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The Evolutionary Perspective
Daily Archives: October 12, 2019
Posted: October 12, 2019 at 12:49 pm
BLOOMINGTON, Ind. -- An astronomer renowned for her work on the black hole at the center of our galaxy will deliver a free public lecture at Indiana University.
Andrea Ghez will present the 2019 Edmondson Lecture, "The Monster at the Heart of Our Galaxy," at 7:30 p.m. Oct. 16 in Rawles Hall, Room 100, on the IU Bloomington campus, followed by a reception. Ghez is the Lauren Leichtman and Arthur Levine Chair of Astrophysics at UCLA.
The event is free and open to the public. No registration is required.
Ghez's work uses the world's most powerful telescopes and next-generation imaging technology to peer into the heart of the Milky Way. Her groundbreaking work has provided the best evidence to date for the existence of the supermassive black hole in the center of the galaxy. It also suggests that the center of most, if not all, other galaxies also harbor these massive objects in their core.
Earlier this year, Ghez's research led to the observation that our galaxy's central black hole -- named Sagittarius A -- has recently grown inexplicably "hungrier," consuming unusually large amounts of gas, dust and other interstellar debris, and flaring so brightly that astronomers briefly mistook it for a star.
During her lecture at IU, Ghez will explore the bizarre environment that surrounds this supermassive object -- which contains an estimated 4.3 million suns' worth of mass -- as well as discuss how her work tests Einstein's theory of relativity.
Ghez is a member of the National Academy of Sciences and a recipient of both the 2008 John D. and Catherine T. MacArthur Foundation Fellowship, commonly known as the "genius grant," and the 2012 Crafoord Prize from the Swedish Academy of Sciences. She holds a doctorate in astrophysics from the California Institute of Technology and a bachelor's degree in physics from MIT.
The annual F.K. Edmondson Astronomy Public Lectures were established to honor the memory of professor Frank Kelly Edmondson, a faculty member of the IU Bloomington Department of Astronomy from 1937 until his retirement in 1983, and chair of the department from 1944 until 1978. Edmondson is remembered not only for his contributions to the study of asteroids through the Indiana Asteroid Program but also for his dedication and service to IU and to the astronomical community. The Edmondson Lectures are endowed in Edmondson's honor by his family and friends.
Originally posted here:
Space shock: Astronomers discover stunning ‘lighthouse beam’ with answers to start of life – Express.co.uk
Posted: at 12:49 pm
The team - led by Professor Joss Bland-Hawthorn from Australia - used data gathered by the Hubble Space Telescope to help understand the evolution of the galaxy. They say that a cataclysmic energy flare ripped through our galaxy some 3.5 million years ago. The massive blast of energy and radiation, known as a Sifter flare, was so powerful that its impact was felt 200,000 light-years from our galaxy.
The flare created two enormous "ionisation cones" that sliced through the Milky Way.
Mr Bland-Hawthorn, who also works at the University of Sydney said that "the flare must have been a bit like a lighthouse beam".
He added: Imagine darkness, and then someone switches on a lighthouse beacon for a brief period of time.
Professor Lisa Kewley, Director of ASTRO 3D said: A massive blast of energy and radiation came right out of the galactic centre and into the surrounding material.
This shows that the centre of the Milky Way is a much more dynamic place than we had previously thought. It is lucky were not residing there!
The discovery that the Milky Ways centre was more powerful than previously thought, is leading to new ideas on the evolution of the Milky Way.
Magma Guglielmo from the University of Sydney, said: "These results dramatically change our understanding of the Milky Way.
"We always thought about our Galaxy as an inactive galaxy, with a not so bright centre.
JUST IN'Monster' black hole 10 times size of Sun is lurking in galaxy
It is a barred spiral galaxy with a diameter between 150,000 and 200,000 light-years and is estimated to contain 100400 billion stars and more than 100 billion planets.
The oldest stars in the Milky Way are nearly as old as the Universe itself and thus probably formed shortly after the Dark Ages of the Big Bang.
Earlier this year scientists were astonished to discover that the giant blackhole at the centre of the Milky Way, Sagittarius A, had suddenly become active after years of being dormant.
The blackhole, which is 4.3 million times bigger than the Sun, has been feeding itself at an unprecedented rate, consuming huge amounts of gas, dust and anything in its vicinity.
Scientists became curious when they discovered it glowing twice as brightly as normal, with a surreal light emanating outside its point of no return beyond which no matter can escape.
Andrea Ghez, UCLA professor of physics and astronomy: "We have never seen anything like this in the 24 years we have studied the supermassive black hole.
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What Astronomers Can Learn From Hot Jupiters, the Scorching Giant Planets of the Galaxy – Smithsonian
Posted: at 12:49 pm
In 1995, after years of effort, astronomers made an announcement: Theyd found the first planet circling a sun-like star outside our solar system. But that planet, 51 Pegasi b, was in a quite unexpected place it appeared to be just around 4.8 million miles away from its home star and able to dash around the star in just over four Earth-days. Our innermost planet, Mercury, by comparison, is 28.6 million miles away from the sun at its closest approach and orbits it every 88 days.
Whats more, 51 Pegasi b was big half the mass of Jupiter, which, like its fellow gas giant Saturn, orbits far out in our solar system. For their efforts in discovering the planet, Michel Mayor and Didier Queloz were awarded the 2019 Nobel Prize for Physics alongside James Peebles, a cosmologist. The Nobel committee cited their contributions to our understanding of the evolution of the universe and Earths place in the cosmos.
The phrase hot Jupiter came into parlance to describe planets like 51 Pegasi b as more and more were discovered in the 1990s. Now, more than two decades later, we know a total of 4,000-plus exoplanets, with many more to come, from a trove of planet-seeking telescopes in space and on the ground: the now-defunct Kepler; and current ones such as TESS, Gaia, WASP, KELT and more. Only a few more than 400 meet the rough definition of a hot Jupiter a planet with a 10-day-or-less orbit and a mass 25 percent or greater than that of our own Jupiter. While these close-in, hefty worlds represent about 10 percent of the exoplanets thus far detected, its thought they account for just 1 percent of all planets.
Still, hot Jupiters stand to tell us a lot about how planetary systems form and what kinds of conditions cause extreme outcomes. In a 2018 paper in the Annual Review of Astronomy and Astrophysics, astronomers Rebekah Dawson of the Pennsylvania State University and John Asher Johnson of Harvard University took a look at hot Jupiters and how they might have formed and what that means for the rest of the planets in the galaxy. Knowable Magazine spoke with Dawson about the past, present and future of planet-hunting, and why these enigmatic hot Jupiters remain important. This conversation has been edited for length and clarity.
What is a hot Jupiter?
A hot Jupiter is a planet thats around the mass and size of Jupiter. But instead of being far away from the sun like our own Jupiter, its very close to its star. The exact definitions vary, but for the purpose of the Annual Review article we say its a Jupiter within about 0.1 astronomical units of its star. An astronomical unit is the distance between Earth and the sun, so its about 10 times closer to its star or less than Earth is to the sun.
What does being so close to their star do to these planets?
Thats an interesting and debated question. A lot of these hot Jupiters are much larger than our own Jupiter, which is often attributed to radiation from the star heating and expanding their gas layers.
It can have some effects on what we see in the atmosphere as well. These planets are tidally locked, so that the same side always faces the star, and depending on how much the heat gets redistributed, the dayside can be much hotter than the nightside.
Some hot Jupiters have evidence of hydrogen gas escaping from their atmospheres, and some particularly hot-hot Jupiters show a thermal inversion in their atmosphere where the temperature increases with altitude. At such high temperatures, molecules like water vapor and titanium oxide and metals like sodium and potassium in the gas phase can be present in the atmosphere.
Between 2009 and 2018, NASA's Kepler space telescope discovered thousands of planets. But exoplanetsplanets outside the solar systemappeared in science fiction before they appeared in telescopes. Astronomers in the early decades of the twentieth century spent entire careers searching for planets in other stellar systems. In The Lost Planets, John Wenz offers an account of the pioneering astronomer Peter van de Kamp, who was one of the first to claim discovery of exoplanets.
What might explain how a planet ends up so close to its star?
There are three categories of models that people have come up with. One is that maybe these planets form close to their stars to begin with. Originally, people sort of dismissed this. But more recently, astronomers have been taking this theory a bit more seriously as more studies and simulations have shown the conditions under which this could happen.
Another explanation is that during the stage when the planetary system was forming out of a disk of gas and dust, the Jupiter was pulled in closer to its star.
The last explanation is that the Jupiter could have started far away from the star and then gotten onto a very elliptical orbit probably through gravitational interactions with other bodies in the system so that it passed very close to the host star. It got so close that the star could raise strong tides on the Jupiter, just like the moon raises tides on the Earth. That could shrink and circularize its orbit so that it ended up close to the star, in the position we observe.
Are there things we see in the planetary systems that have hot Jupiters that other systems dont have?
There are some trends. One is that most hot Jupiters dont have other small planets nearby, in contrast to other types of planetary systems we see. If we see a small hot planet, or if we see a gas giant thats a bit farther away from its star, it often has other planets nearby. So hot Jupiters are special in being so lonely.
The loneliness trend ties in to how hot Jupiters formed so close to their stars. In the scenario where the planet gets onto an elliptical orbit that shrinks and circularizes, that would probably wipe out any small planets in the way. That said, there are a few systems where a hot Jupiter does have a small planet nearby. With those, its not a good explanation.
Planetary systems with hot Jupiters often have other giant planets in the system farther away out beyond where the Earth is, typically. Perhaps, if hot Jupiters originated from highly eccentric orbits, those faraway planets are responsible for exciting their eccentricities to begin with. Or there could have been responsible planets that got ejected from the system in the process, so we dont necessarily have to still see them in the system.
Another big trend is that hot Jupiters tend to be around stars that are more metal-rich. Astronomers refer to metals as any element heavier than hydrogen or helium. Theres more iron and other elements in the star, and we think that this may affect the disk of gas and dust that the planets formed out of. There are more solids available, and that could facilitate forming giant planets by providing material for their cores, which would then accrete gas and become gas giants.
Having more metals in the system could enable the creation of multiple giant planets. That could cause the type of gravitational interaction that would put the hot Jupiter onto a high eccentricity orbit.
Hot Jupiters like 51 Pegasi b were the first type of planet discovered around sun-like stars. What led to their discovery?
It occurred after astronomers started using a technique called the radial velocity method to look for extrasolar planets. They expected to find analogs to our own Jupiter, because giant planets like this would produce the biggest signal. It was a very happy surprise to find hot Jupiters, which produce an even larger signal, on a shorter timescale. It was a surprising but fortuitous discovery.
Can you explain the radial velocity method?
It detects the motion of the host star due to the planet. We often think of stars sitting still and theres a planet orbiting around it. But the star is actually doing its own little orbit around the center of mass between the two objects, and thats what the radial velocity method detects. More specifically, it detects the doppler shift of the stars light as it goes in its orbit and moves towards or away from us.
One of the other common ways to find planets is the transit method, which looks for the dimming of a stars light due to a planet passing in front of it. Its easier to find hot Jupiters than smaller planets this way because they block more of the stars light. And if they are close to the star they transit more frequently in a given period of time, so were more likely to detect them.
In the 1990s, many of the exoplanets astronomers discovered were hot Jupiters. Since then, weve found more and different kinds of planets hot Jupiters are relatively rare compared with Neptune-sized worlds and super-Earths. Why is it still important to find and study them?
One big motivation is the fact that theyre out there and that they werent predicted from our theories of how planetary systems form and evolve, so there must be some major pieces missing in those theories.
Those missing ingredients probably affect many planetary systems even if the outcome isnt a hot Jupiter a hot Jupiter, we think, is probably an extreme outcome. If we dont have a theory that can make hot Jupiters at all, then were probably missing out on those important processes.
A helpful thing about hot Jupiters is that they are a lot easier to detect and characterize using transits and radial velocity, and we can look at the transit at different wavelengths to try to study the atmosphere. They are really helpful windows into planet characterization.
Hot Jupiters are still going to always be the planets we can probe in the most detail. So even though people dont necessarily get excited about the discovery of a new hot Jupiter anymore, increasing the sample lets us gather more details about their orbits, compositions, sizes or what the rest of their planetary system looks like, to try to test theories of their origins. In turn, theyre teaching us about processes that affect all sorts of planetary systems.
What questions are we going to be able to answer about hot Jupiters as the next-generation observatories come up, such as the James Webb Space Telescope and larger ground-based telescopes?
With James Webb, the hope is to be able to characterize a huge number of hot Jupiters atmospheric properties, and these might be able to help us test where they formed and what their formation conditions were like. And my understanding is that James Webb can study hot Jupiters super quickly, so it could get a really big sample of them and help statistically test some of these questions.
The Gaia mission will be really helpful for characterizing the outer part of their planetary systems and in particular can help us measure whether massive and distant planets are in the same plane as a transiting hot Jupiter; different theories predict differently on whether that should be the case. Gaia is very special in being able to give us three-dimensional information, when usually we have only a two-dimensional view of the planetary system.
TESS [the Transiting Exoplanet Survey Satellite space telescope] is going on right now and its discoveries are around really bright stars, so it becomes possible to study the whole system that has a hot Jupiter using the radial velocity method to better characterize the overall architecture of the planetary system. Knowing whats farther out will help us test some of the ideas about hot Jupiter origins.
TESS and other surveys also have more young stars in the sample. We can see what the occurrence rate and properties are of hot Jupiters closer to when they formed. That, too, will help us distinguish between different formation scenarios.
Theyre alien worlds to us, but what can hot Jupiters tell us about the origins of our own solar system? These days, many missions are concentrating on Earth-sized planets.
What were all still struggling to see is: Where does our solar system fit into a bigger picture of how planetary systems form and evolve, and what produces the diversity of planetary systems we see? We want to build a very complete blueprint that can explain everything from our solar system, to a system with hot Jupiters, to a system more typical of what [the retired space telescope] Kepler found, which are compact, flat systems of a bunch of super-Earths.
We still dont have a great explanation for why our solar system doesnt have a hot Jupiter and other solar systems do. Wed like some broad theory that can explain all types of planetary systems that weve observed. By identifying missing processes or physics in our models of planet formation that allow us to account for hot Jupiters, were developing that bigger picture.
Do you have any other thoughts?
The one thing I might add is that, as we put together all the evidence for our review, we found that none of the theories can explain everything. And that motivates us to believe that theres probably multiple ways to make a hot Jupiter so its all the more important to study them.
Knowable Magazine is an independent journalistic endeavor from Annual Reviews.
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Space discovery: Astronomers warn of colossal galaxy explosion heading towards Earth – Express.co.uk
Posted: at 12:49 pm
Early humans may have witnessed such an explosion over 3.5 million years ago - and it could happen again very soon according to researchers. Scientists call the cosmic gas orbs the Fermi bubbles and even though theyre a few million years old there is a mystery as to how the bubbles first formed. Researchers from the University of Sydney reconstructed a plausible explanation for the bubbles birth, putting it down to a gigantic explosion.
The Fermi bubbles were created by an epic flare of hot nuclear energy that shot out the galaxys poles roughly 3.5 million years ago.
A beam from the explosion shot into space for hundreds of thousands of light-years.
Lead study author Joss Bland-Hawthorn told Live Science, the effect would have shone out of the galaxys centre for 300,000 years.
Mr Bland-Hawthorn also noted that a similar explosion or flare could have occurred 10 million years ago and could well be heading towards Earth.
He said: It's plausible that one explosion took place 10 million years ago, and the jet is now arriving in our direction.
Speaking on the flare, the director of the Sydney Institute for Astronomy and his team calculated the blast may have been visible to early humans.
He said: It's an amazing thought that, when cave people walked the Earth, if they'd looked off in the direction of the galactic centre, they'd have seen some kind of giant ball of heated gas.
JUST IN:Building blocks of DNA could have been present in gas clouds in space
Researchers looked to the Hubble Space Telescope of the Magellanic Stream to date the explosion.
The Magellanic stream is a 600,000-light-year-wide arc of gas trailing behind two dwarf galaxies that orbit the Milky Way.
From the Earth, the Magellanic Stream spreads across half of the night sky as it surges through space some 200,000 light-years away.
It is still close enough for neighbouring galaxies to feel the heat of particularly violent eruptions from our galaxys central black hole, according to the researchers.
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While most of the hydrogen gas makes up the Magellanic Stream is very cold, recent Hubble observations have revealed at least three large regions where the gas is unusually hot.
Those regions, incidentally, align with the north and south poles of the Milky Way's galactic centre.
According to Mr Bland-Hawthorn, thats a clear sign that those hot regions were toasted by an enormous flare-up of charged particles beaming out of our galaxy and into deep space.
He said: This can only be done radiatively from the monster at the galaxy's nucleus.
The scientist and his colleagues showed how such an explosion of energy, known as a Seyfert flare, could blast out of the centre and reach all the way to the hottest regions of the Magellanic stream.
The team calculated the explosion must have occurred between 2.5 and 4.5million years ago - a time when humanitys early ancestors were already walking the Earth.
While early humans may have seen the mysterious flare overhead, Mr Bland-Hawthorn believes it is unlikely they were impacted by its energy due to the earth's protective atmosphere.
e added how it was good news for humanity as research suggests more Seyflert flares could be on their way.
The scientist stated that flares can get trapped in the immediate vicinity of the back holes that made them for millions of years.
He added: But I think the most powerful bursts from our Sun would be about the same power so, bad for satellites and space walkers, but our atmosphere protects life pretty well."
Posted: at 12:49 pm
Down on Earth around 3.5 million years ago, humanity was starting to take its earliest forms in some regions of Africa. At the same time, the sky was bursting with radiation from an explosive flare that took place in the center of the Milky Way.
An international team of astronomers recently found evidence of the explosion, the impact of which extended across 200,000 light-years and released a flash of energy that shone out into space through the two poles of our galaxy. And while humans probably couldnt see this flare, if there are any intelligent beings in the rest of the galaxy, they may have caught a glimpse.
The study, published on Sunday in The Astrophysical Journal, is based on observations made by the Hubble Space Telescope that caught the afterglow of the flare.
Gerald Cecil, Ph.D., professor of physics and astronomy at the University of North Carolina and co-author of the study, believes that the flare was caused by gas and shattered stars falling into the supermassive black hole at the center of the Milky Way.
We then see this glowing light, Cecil tells Inverse. Although we dont have a direct view of the explosion in the center, we see its reflective light.
The new study is based on a 2013 discovery of the Magellanic Stream, a stream of gas clouds that extends over the Milky Way, as shown in the video above. Light from distant quasars, massive and extremely bright cosmic objects, passed through the stream on its way to Earth. The composition of the arc, which removed some parts of the quasar light, led the team to suspect that something was heating and lighting up the gas stream.
What the team managed to observe was the fading remnant of the explosion, which was much brighter when it occurred 3.5 million years ago.
The fire is over, and were looking at the glowing coals, Cecil says. A lightbulb burning out.
The researchers estimate that the blast may have lasted for 300,000 years but is no longer active today based on mathematical models of how the heated gas de-energized.
The supermassive black hole in the Milky Way is always flickering, if an asteroid fell in instead of dust, you might get a flare that lasts for hours, Cecil says.
The new findings suggest that our galaxy is more active than we had initially thought it to be. The Milky Way is known to have some low level activity but, according to Cecil, this new research suggests that it was perhaps a million times more active only a few million years ago than what astronomers believed in the past.
Other galaxies have this behavior, Cecil says. It puts the Milky Way into the mainstream.
Considering that this event took place only a couple of million years ago, an insignificant amount of time in the life of a galaxy, means that it may be one of many such episodes that have occurred over the lifetime of the Milky Way.
If we start thinking about the cumulative effects of those radiation, we have to incorporate them in the models of whats going on in the Milky Way, Cecil says. That hasnt been done reliably.
The new study casts the Milky Way in a new, perhaps brighter, light, as well as the activity of the black hole at its center, if it is in fact the culprit behind this relatively recent explosion. The team behind the research hopes to get a better understanding of the duration of the flare, and whether it flared back up again during that period or continued to fade gradually.
Another aspect of the findings that Cecil points out is that this galactic event may have been observed by other inhabitants of the Milky Way, which he strongly believes exist, and essentially synchronized everybodys clock to a point of reference in the galaxys timescale.
Here is an event thats galaxy wide, for wherever they are in the galaxy, Cecil says. There was an event, one that everyone could see.
Abstract: There is compelling evidence for a highly energetic Seyfert explosion (105657 erg) that occurred in the Galactic Centre a few million years ago. The clearest indications are the x-ray/-ray 10 kpc bubbles identified by the Rosat and Fermi satellites. In an earlier paper, we suggested another manifestation of this nuclear activity, i.e. elevated H emission along a section of the Magellanic Stream due to a burst (or flare) of ionizing radiation from Sgr A*. We now provide further evidence for a powerful flare event: UV absorption line ratios (in particular CIV/CII, Si IV/Si II) observed by the Hubble Space Telescope reveal that some Stream clouds towards both galactic poles are highly ionized by a source capable of producing ionization energies up to at least 50 eV. We show how these are clouds caught in a beam of bipolar, radiative ionization cones from a Seyfert nucleus associated with Sgr A*. In our model, the biconic axis is tilted by about 15 from the South Galactic Pole with an opening angle of roughly 60. For the Stream at such large Galactic distances (D > 75 kpc), nuclear activity is a plausible explanation for all of the observed signatures: elevated H emission and H ionization fraction (xe > 0.5), enhanced CIV/CII and Si IV/Si II ratios, and high CIV and Si IV column densities. Wind-driven shock cones are ruled out because the Fermi bubbles lose their momentum and energy to the Galactic corona long before reaching the Stream. Our time-dependent Galactic ionization model (stellar populations, hot coronal gas, cloud-halo interaction) is too weak to explain the Streams ionization. Instead, the nuclear flare event must have had a radiative UV luminosity close to the Eddington limit (fE 0.1 1). Our time-dependent Seyfert flare models adequately explain the observations and indicate the Seyfert flare event took place To = 3.5 1 Myr ago. The timing estimates are consistent with the mechanical timescales needed to explain the x-ray/-ray bubbles in leptonic jet/wind models ( 2 8 Myr).
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Lilly Presents Positive Results for Taltz (ixekizumab) in Pediatric Patients with Moderate to Severe Plaque Psoriasis at the 28th Annual European…
Posted: at 12:48 pm
INDIANAPOLIS, Oct. 12, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area and Severity Index score (PASI 75) and 81 percent of patients treated with Taltz achieved a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1). Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain. Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.
"Results from our study indicate that Taltz may have the potential to clear skin and reduce itch in pediatric patients with moderate to severe plaque psoriasis," said study investigator Kim Papp, MD, PhD, Probity Medical Research, Inc., Waterloo, Ontario, Canada. "While it is estimated that up to one third of people with psoriasis first develop symptoms during childhood, there are limited medications available for pediatric patients. This study provides encouraging data supporting the potential for Taltz to become another treatment option for this patient population."
The co-primary endpoints of the study were the proportion of patients achieving a significant 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS 4) among patients with baseline Itch NRS 4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children's Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients 17 years old) at Week 12 was also evaluated.
"We recognize that psoriasis can have a significant impact on children and adolescents, causing challenging symptoms and affecting their self-esteem and ability to connect to peers," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We're pleased to see positive results for Taltz in pediatric patients. These results build on more than five years of safety and efficacy data in adults and support the potential for Taltz in this new population, pending regulatory approvals."
A total of 201 patients aged 6 to <18 years of age with moderate to severe plaque psoriasis were randomized to receive Taltz (20 mg for <25 kg, 40 mg for 25-50 kg or 80 mg for >50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference (P<0.001), including:
Taltz also met all major secondary endpoints in the study (P<0.001).
In this trial, the overall safety profile of Taltz was consistent with previously reported results. The Taltz safety profile has been studied across 15 clinical trials in plaque psoriasis and psoriatic arthritis, with 6,989 patients receiving Taltz, with a total exposure of 16,586 patient-years.1,2,3
INDICATIONS AND USAGE FOR TALTZTaltz is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also approved for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.
IMPORTANT SAFETY INFORMATION FOR TALTZ
CONTRAINDICATIONSTaltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
WARNINGS AND PRECAUTIONSInfectionsTaltz may increase the risk of infection. In clinical trials of patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of patients with psoriatic arthritis and ankylosing spondylitis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
Pre-Treatment Evaluation for TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.
HypersensitivitySerious hypersensitivity reactions, including angioedema and urticaria (each 0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel DiseaseDuring Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz 80 mg Q2W group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn's disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn's disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.
ImmunizationsPrior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.
ADVERSE REACTIONSMost common adverse reactions (1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.
Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.
IX HCP ISI 23AUG2019
About TaltzTaltz (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.4 IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.4
About Moderate to Severe Plaque Psoriasis Psoriasis is a chronic, immune disease that affects the skin.5 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis affects approximately 125 million people worldwide, approximately 20 percent of whom have moderate to severe plaque psoriasis.5,6 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.5 Patients with plaque psoriasis often have other serious health conditions, such as diabetes and heart disease and experience negative impact on their quality of life.5
About the Phase 3 Pediatric Study This study is a Phase 3, multicenter, randomized, double-blinded, placebo controlled study to evaluate safety, tolerability and efficacy of Taltz in patients from 6 to <18 years of age with moderate to severe plaque psoriasis. The co-primary endpoints of the study were the proportion of patients achieving a 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA 0 and PASI 100 at Week 12, and at least a four-point improvement in Itch numeric rating scale (Itch NRS 4) among patients with baseline Itch NRS 4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children's Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients 17 years old) at Week 12 was also evaluated.
About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.
About Eli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a potential treatment for pediatric patients with moderate to severe plaque psoriasis, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that Taltz will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertake no duty to update forward-looking statements to reflect events after the date of this release.
1 Data on file. Lilly USA, LLC. TAL20171211A.2 Data on file. Lilly USA, LLC. DOF-IX-US-0019.3 Mease P, Roussou E, Burmester GR, et al. Safety of ixekizumab in patients with psoriatic arthritis: results from a pooled analysis of three clinical trials. Arth Care Res. 2018 (Epub). doi:10.1002/acr.23738.4 Taltz Prescribing Information, 2019.5 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed September, 2019.6 Skin conditions by the numbers. American Academy of Dermatology website. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed September, 2019.
SOURCE Eli Lilly and Company
Sun Pharma Presents Long-term Study Results that Show Significant Skin Clearance with ILUMYA (tildrakizumab-asmn) Maintained Over Four Years in People…
Posted: at 12:48 pm
MUMBAI, India and PRINCETON, N.J., Oct. 9, 2019 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" including its subsidiaries and/or associate companies) today announced that one of its wholly owned subsidiaries presented long-term follow-up data from ILUMYA (tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials at the 28th European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.
The data showed that the significant response rates seen in the initial 52 and 64 weeks, respectively, were maintained over four years for people with moderate-to-severe plaque psoriasis, with more than half of participants achieving at least 90 percent skin clearance (Psoriasis Area Sensitivity Index (PASI) 90) and no new safety concerns recorded.1,2 Additional study analyses showed that the 75 to 100 percent skin clearance achieved with ILUMYA treatment over three years was sustained equally in people with and without metabolic syndrome,3,4 a common condition in people with psoriasis.5
Click to Tweet #NEWS: @SunPharma_Live presents long-term data showing significant skin clearance response maintained in people with moderate-to-severe plaque psoriasis over four years at #EADV2019. Read more: https://bit.ly/2F4CEoo
"Psoriasis is an individualized condition and it can be a challenge for clinicians to prescribe a medicine that's effective over time, especially for patients with co-morbid conditions like metabolic syndrome," said Jeffrey Crowley, M.D., Bakersfield Dermatology, Bakersfield, California. "These data provide confidence that ILUMYA can help patients with moderate-to-severe plaque psoriasis, regardless of metabolic syndrome, achieve and maintain significant skin clearance over the long-term."
Eligible participants in the ILUMYA Phase 3 reSURFACE 1 and 2 trials who remained on treatment for the open-label extension studies received ILUMYA for a total of 208 weeks (reSURFACE 1) and 200 weeks (reSURFACE 2).1,2 After four years, ILUMYA treatment led to significant and durable observed improvements in PASI and Physician Global Assessment (PGA) scores key measures of disease severity.1,2
ILUMYA 100 mg was well-tolerated, with a low rate of adverse events (AEs) that were comparable or numerically lower than placebo based upon exposure-adjusted rates for many AE categories.1,2
Researchers also analyzed the reSURFACE 1 and reSURFACE 2 studies to glean insights into whether ILUMYA's efficacy was similar in people with metabolic syndrome (defined as elevated blood pressure, body mass index/obesity, triglycerides and glucose and low HDL cholesterol levels), as this co-morbid condition can negatively affect people's response to most biologic psoriasis medicines.6 This post-hoc analysis showed that the skin clearance levels achieved and sustained with ILUMYA 100 mg at three years were comparable in participants with and without metabolic syndrome.3,4
Three-year adverse event rates usually associated with metabolic syndrome, such as infections, cardiovascular events or complications of diabetes, were no different in study participants with and without metabolic syndrome.3,4
"Moderate-to-severe psoriasis is a lifelong condition, and at Sun Pharma we're committed to helping people find treatment options that work consistently over time, regardless of any co-morbid conditions, to help manage the frustrating symptoms that for so many years are a part of everyday life," said Alan Mendelsohn, M.D., Associate Vice President, Dermatology Medical Affairs, Sun Pharma. "ILUMYA has been proven to provide significant skin clearance that begins soon after initial use and is maintained for years, with just four doses a year following two starter doses, without demonstrating any new or increased risk of safety events."
About the Studies
reSURFACE 1 Extension StudyreSURFACE 1 was a three-part, double-blind, randomized, controlled, 64-week study that evaluated ILUMYA 100 mg and 200 mg at weeks 0 and 4, and every subsequent 12 weeks in adults with moderate-to-severe chronic plaque psoriasis. Participants with at least 50 percent improvement in PASI 50 at base study completion who received ILUMYA within 12 weeks of base study end (week 64) were eligible to enroll in the extension study and continued on the same ILUMYA dose once every 12 weeks. Researchers evaluated PASI and PGA response (score of 0 or 1 with 2 grade reduction from baseline) and incidence rates for prespecified adverse events, including severe infections, cardiovascular events and drug-related hypersensitivities.
reSURFACE 2 Extension StudyreSURFACE 2 was a three-part, double-blind, randomized, controlled, 52-week study that compared the safety and efficacy of ILUMYA 100 mg and 200 mg to placebo and etanercept 50 mg. At Week 12, patients with at least a 50 percent improvement in PASI 50 at base study completion on ILUMYA 100 or 200 mg were eligible to enroll in the extension study and continued on the same ILUMYA dose every 12 weeks. Partial and non-responders to etanercept were converted to treatment with ILUMYA200 mg, while responders (PASI 75) were discontinued. Researchers evaluated PASI and PGA response (score of 0 or 1 with 2 grade reduction from baseline) and incidence rates for prespecified adverse events, including severe infections, cardiovascular events and drug-related hypersensitivities.
reSURFACE 1 and reSURFACE 2 Post-Hoc AnalysesPost-hoc analyses of reSURFACE 1 and reSURFACE 2 were conducted to evaluate changes in ILUMYA's efficacy in people with and without metabolic syndrome, which was previously defined as those who met the National Cholesterol Education Program-Adult Treatment Panel III criteria (including elevated blood pressure, body mass index [BMI], triglycerides, and glucose). Researchers stratified efficacy results determined by proportion of patients with at least PASI 75 and absolute and median percent PASI change from baseline up to week 148 in both studies.
ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in Australia and under the brand name ILUMETRITM in Europe.
INDICATION AND IMPORTANT SAFETY INFORMATION
ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS:
Hypersensitivity: Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
Infections: ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves.
Pretreatment Evaluation for Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment.
Immunizations: Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.
Adverse Reactions: The most common (1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.
Please click here for Full Prescribing Information and Medication Guide.
About Sun Dermatology
Sun Dermatology (the branded dermatology division of a wholly owned subsidiary of Sun Pharmaceutical Industries Inc.) is committed to expanding its dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions like moderate-to-severe plaque psoriasis. Sun Pharmaceutical Industries Ltd., along with its subsidiaries, is ranked second in dermatology prescription volume within the U.S. per IQVIA and is the fourth largest specialty generic pharmaceutical company globally. In addition to ILUMYA, Sun Dermatology is comprised of several branded products with a focus on various dermatologic conditions.
About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050)
Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit http://www.sunpharma.com & follow us on Twitter @SunPharma_Live.
Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.
SOURCE Sun Pharmaceutical Industries Ltd.
Researchers Identify Differences Between Axial Psoriatic Arthritis and Ankylosing Spondylitis – Consultant360
Posted: at 12:48 pm
Persons with ankylosing spondylitis (AS)with or without psoriasishave different demographic, genetic, radiographic, and clinical variables from persons with axial psoriatic arthritis (axPsA), according to results of a new study. The findings suggest that axPsA is a distinct entity.
The researchers compared data of patients with AS with psoriasis (n=91) and patients with AS without psoriasis (n=675) with data of patients with axPsA (n=477) and patients with peripheral PsA (n=826).
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All patients cases were followed prospectively using the same protocol. A logistic regression analysis was performed and adjusted for follow-up duration.
Results showed that patients with AS with or without psoriasis were younger, were more often male, were positive for HLA-B*27 antigen, had received more treatment with biologics, and had a higher grade of sacroiliitis.
Additionally, patients with AS had more back pain at presentation, worse Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Metrology Index scores, and worse physician global assessments.
Similar differences were detected when patients with AS and psoriasis were compared with those with axPsA, and in a regression model.
Feld J, Ye JY, Chandran V, et al. Is axial psoriatic arthritis distinct from ankylosing spondylitis with and without concomitant psoriasis? [published online October 8, 2019]. Rheumatology. doi:10.1093/rheumatology/kez457.
Scots psoriasis sufferer opens up on how skin condition can affect mental health and leave her not wanting to – The Scottish Sun
Posted: at 12:48 pm
A SCOTS psoriasis sufferer has told how the condition has impacted her relationship by leaving her not wanting to be "touched, cuddled or kissed".
Jude Duncan, 26, has had the irritating skin condition for six years and says it can affect intimate relationships and dating.
The marketing officer, who is a 'Skinfluencer' on Instagram has been with her boyfriend for two years and says she is lucky that he is very supportive.
But she also has moments where her itchy and flaky skin affects her mental health and leaves her not wanting intimacy.
Psoriasis, which affects around 2 per cent of people in the UK, is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Jude, from Gourock, told the Scottish Sun: "Im very lucky to have a supportive partner but I know that if I'm not having a great nights sleep, and tossing and turning, then hes not getting a great nights sleep and that can have an impact on them as well.
"Actually having that communication with a partner is really important but it can be really difficult as well for people to open up.
"I'm in a lucky position where I feel very confident with my psoriasis but also sometimes it has felt like if I'm having a flare up I dont want to be touched, I dont want to cuddled, I dont want to be kissed. So it does have that impact on it.
"I wouldn't say that because Im with someone I havent had those difficulties."
She added: "Its very hard to get your partner to understand what you're going through mentally as well as the physical aspect of it.
"And the fact that they cant do anything to help puts a strain on it, so its just different."
Jude also had a period of time before she was in a relationship where she was trying to date - but potential suitors were put off by her condition.
She has hit out at the 'Insta perfect' world which means people can be very shallow and focus on a person's perceived flaws.
She said: "On every date I would be asked 'what's wrong with your face' and stuff like that, so it was definitely a topic of conversation.
"It was the elephant in the room, like when is this going to be brought up.' And thats not how it should be.
"It shouldnt matter if I have a bit of psoriasis on my face or not whether you want a second date, but it really did impact that a lot.
"We live in this Insta perfect world where people with flaws or differences arent seen to be good enough and people dont want to be seen with someone like that.
"But to be honest with you if you have a problem with how I look, I dont really want to date anyone that treats people like that anyway."
Negative affect on Mental Health
Speaking on Mental Health day, Jude explained how various factors surrounding the condition can affect a person's mental wellness.
That includes the discomfort itself, but also the negative impact of how other people treat you.
Stats show that 67 per cent of sufferers believe that the condition can have an affect on your mental health.
Jude said: "If you are uncomfortable and thats causing you to not sleep then thats going to have an affect on your mental health, but also just that uncomfortableness all the time, being in a constant state of irritation, not being able to relax - that is going to have a toll on your mental health.
"A lot of people are like oh lets focus on treating the skin but they dont look at surrounding factors such as mental health.
"Because its such a visual condition it can make you incredibly insecure and really lonely and isolated because it's not really talked about. So that can also have an impact on your mental health because you feel like youre bottling it up and not talking about it.
"If youre not getting any sleep that means the next day you're not going to be functioning to your full potential, and you're stressing yourself out because you're not maybe getting as much done as you want and that's going to result in you stressing out more, which is going to affect your sleep, which is going to affect your mental health and its just a really vicious cycle.
Mental health stats:
Public perception stat:
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"I think for me as well, when people stare or make comments, sometimes they mean well but that can really also play on your mental health."
She added: "I definitely had comments in the past. I've had people say really horrible things to my face.
"But I'm OK that in that I'm in a position where I'm confident enough. There's so many people out there that arent and a situation like that would knock their confidence.
"I was in a position that I was able to move on and deal with it but thats not always the case."
If you are affected by any of the issues raised in this article, please call the Samaritans on (free) 116123.
We pay for your stories and videos! Do you have a story or video for The Scottish Sun? Email us at email@example.com or call 0141 420 5300
AbbVie Announces New Data from its Dermatology Portfolio and Pipeline at the 28th European Academy of Dermatology and Venereology (EADV) Congress -…
Posted: at 12:48 pm
NORTH CHICAGO, Ill., Oct. 9, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it will present new results evaluating the safety and efficacy of SKYRIZI (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as additional data on HUMIRA (adalimumab) and the investigational JAK inhibitor upadacitinib, at the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid.
"Leveraging more than two decades of clinical experience with HUMIRA, AbbVie recently expanded its dermatology portfolio with the approval of SKYRIZI for patients living with moderate to severe plaque psoriasis," said Marek Honczarenko, MD, PhD, vice president, global immunology development, AbbVie. "The new data presented at EADV will advance the knowledge around new and existing treatments for serious skin diseases, like psoriasis, as well as diseases with high levels of unmet need, such as atopic dermatitis and hidradenitis suppurativa."
In addition to sharing new long-term data from the LIMMitless open-label extension study in moderate to severe plaque psoriasis, AbbVie will share results from its ongoing investigational Phase 2 program evaluating risankizumab for the treatment of psoriatic arthritis. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
In addition, Phase 2b results evaluating time to treatment response with upadacitinib, an oral JAK inhibitor, under investigation for patients with moderate to severe atopic dermatitis will be shared as an oral presentation. Upadacitinib is not approved for atopic dermatitis by any regulatory authority, and its safety and efficacy have not been established in this indication.
Additional presentations include efficacy and safety results further evaluating HUMIRA in hidradenitis suppurativa.
"Chronic skin diseases can have a significant physical and psychosocial impact on patients," said Jean-Marie Meurant, board president of the International Alliance of Dermatology Patient Organizations. "While progress has been made to improve the lives of patients, many still do not have access to the treatment and care they need and deserve. It's critical that the scientific community build upon current research to better understand these diseases and continue to keep the patient experience at the forefront of their efforts."
AbbVie Data at EADV
Risankizumab Abstracts Psoriasis
Upadacitinib AbstractsAtopic dermatitis
Disease State AbstractsHidradenitis suppurativa
About SKYRIZI (risankizumab) in the EU1
SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Important EU Safety Information1
SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in clinically important active infections. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.
This is not a complete summary of all safety information. See the full summary of product characteristics (SmPC) at http://www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.
Discovered and developed by AbbVie, upadacitinib is an investigational, oral, small molecule JAK inhibitor being studied for moderately to severely active rheumatoid arthritis and other immune-mediated inflammatory diseases.2-15 Phase 3 trials of upadacitinib in psoriatic arthritis, Crohn's disease, atopic dermatitis and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis and giant cell arteritis.10-15
About HUMIRA in the EU16
HUMIRA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
HUMIRA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.
Important EU Safety Information16
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.
This is not a complete summary of all safety information. Globally, prescribing information varies; refer to the individual country product label for complete information.
Full summary of product characteristics is available at: http://www.ema.europa.eu
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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