People with psoriasis who havent seen improvement with standard treatments now have a new option. The Food and Drug Administration (FDA) has approved the injectable drug Siliq (broadalumab) for the treatment of moderate-to-severe plaque psoriasis in adults.
Because of an association with suicidal thoughts and behaviors, Siliq will be sold with a "black box" warning and should be considered only for patients whose psoriasis has not respondedor has stopped respondingto phototherapy or to other systemic medicines taken orally or via injection.
Plaque psoriasis is an autoimmune condition that causes cells to build up on the surface of the skin, forming thick red patches and flaky silver-white scales. Current treatment options for psoriasis include topical treatments (like corticosteroids) phototherapy (using an ultraviolet light box or a laser) and systemic drugsdelivered via a pill, an injection or an IV infusionthat work throughout the body.
Siliq is unique because it binds to the receptor of a protein called interleukin-17, a known contributor to inflammation. By blocking the receptor from being activated, it keeps the body from receiving signals that can fuel inflammatory responses and psoriasis progression. Two other psoriasis drugs currently on the market work similarly, but instead bind to the protein itself.
This small difference is significant, says Dr. Richard Fried, a member of the National Psoriasis Foundation medical board, since responses to drug treatments can vary dramatically from person to person. "Having another agent in our armamentarium that works by a different mechanism is a welcome addition and may prove beneficial to many psoriasis suffers," he says in an email. (Fried says he has no involvement with the drug or the drug company.)
In the three clinical trials considered for drug approval, more than 50% of patients who used Siliq achieved total skin clearancethe ultimate goal of psoriasis treatmentswithin a year. The most common side effects of the drug were joint and muscle pain, headache, fatigue, diarrhea, throat pain, nausea, flu, low white blood cell count, fungal infections and reactions at the injection site.
The drug also comes with a more serious warning, as well. In a total of six clinical trials totaling about 6,200 participants, six suicides were reported by people receiving Siliq. People with a history of suicide attempts or depression had an increased risk of suicidal ideation and behavior.
Because of these events, the labeling for Siliq will include a Boxed Warning, and the drug will only be available through a restricted REMS (Risk Evaluation and Mitigation Strategy) program. In order to prescribe it, doctors must be certified with the program and must counsel patients about this risk. Patients must also agree to seek medical attention should they experience new or worsening mood changes, anxiety or suicidal thoughts.
A causal association between Siliq and increased risk of suicidal ideation and behavior has not been established. Fried, a dermatologist and clinical psychologist, points out that psoriasis itself can be associated with mental health problems .
"E ffective treatment has consistently shown reduction in the incidence and severity of depression and reduced likelihood of suicide," says Fried. He adds that the data on Siliq suggests that it is not only effective in treating psoriasis, but that many patients experience improvement in anxiety and depression, as well.
Siliq, like other psoriasis medications, also affects the immune system. It can raise patients risk of infections and shouldnt be used by people with certain chronic conditions, such as Crohns disease or active tuberculosis infections. People should also avoid immunizations with live vaccines while being treated with Siliq.
"Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment," said Dr. Julie Beitz, director of the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research, in an agency press release .
The drug's recommended dosage schedule is an injection once a week for the first three weeks, followed by an injection every other week. Valeant Pharmaceuticals, Siliq's manufacturer, says that pricing information is not available at this time, and expects to begin sales and marketing in the second half of 2017.
Read the rest here:
How a New Psoriasis Drug Is Different From Others - TIME
- Why Jews With Psoriasis Might Think Twice About Seeking Treatment in Jordan - December 20th, 2013 [December 20th, 2013]
- Skin conditions leave emotional scars - December 20th, 2013 [December 20th, 2013]
- Psoriasis Free Forever Review | How This Program Helps People Treat The Root Causes Of Their Psoriasis Symptoms ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis | University of Maryland Medical Center - December 20th, 2013 [December 20th, 2013]
- Psoriasis Treatment, Symptoms, Pictures, Types, Prognosis ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis - National Library of Medicine - PubMed Health - December 20th, 2013 [December 20th, 2013]
- Psoriasis: MedlinePlus - U.S. National Library of Medicine - December 20th, 2013 [December 20th, 2013]
- Psoriasis - Wikipedia, the free encyclopedia - December 20th, 2013 [December 20th, 2013]
- Psoriasis Symptoms, Treatment, Causes, Medication Information ... - December 21st, 2013 [December 21st, 2013]
- Psoriasis Free For Life Review - Watch This Before You Buy - Video - December 21st, 2013 [December 21st, 2013]
- Natural Psoriasis Relief in Seattle, Washington - Video - December 21st, 2013 [December 21st, 2013]
- PSORIASIS VULGARIS - Video - December 21st, 2013 [December 21st, 2013]
- Top 5 Powerful Home Remedies For Psoriasis - Video - December 21st, 2013 [December 21st, 2013]
- Psoriasis feedback after hijama - Video - December 21st, 2013 [December 21st, 2013]
- 9 Home Remedies For Scalp Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- Manga - Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- How to treat psoriasis | In Good Shape - Interview - Video - December 22nd, 2013 [December 22nd, 2013]
- Best Scalp Psoriasis Treatment - Video - December 22nd, 2013 [December 22nd, 2013]
- Sandoz begins Phase III clinical trial for biosimilar adalimumab - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis - Wikipedia, la enciclopedia libre - December 23rd, 2013 [December 23rd, 2013]
- What Is Psoriasis? - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis Treatment Medical Course - Video - December 23rd, 2013 [December 23rd, 2013]
- Healing Psoriasis Hypnosis Session - Video - December 23rd, 2013 [December 23rd, 2013]
- Natural Farm cure for Skin Problems like Psoriasis - Video - December 26th, 2013 [December 26th, 2013]
- Psoriasis - 100% Natural Treatment Shivax® - December 27th, 2013 [December 27th, 2013]
- Psoriasis Symptoms, Causes, Treatment - What is psoriasis ... - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P3 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P2 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P1 - Video - December 28th, 2013 [December 28th, 2013]
- Can Acupuncture treat psoriasis and other scalp disorders? - Video - December 28th, 2013 [December 28th, 2013]
- Psoriasis - Wikipédia - December 31st, 2013 [December 31st, 2013]
- Psoriatic nails - Wikipedia, the free encyclopedia - December 31st, 2013 [December 31st, 2013]
- How to Cure Psoriasis - Psoriasis Symptoms, Treatment, Causes, Medication Information - Video - December 31st, 2013 [December 31st, 2013]
- Psoriasis Chronicles - Dealing with Depression, Anxiety and Anger - Video - January 2nd, 2014 [January 2nd, 2014]
- How to Prevent Psoriasis Flare-Ups - January 4th, 2014 [January 4th, 2014]
- Psoriasis Treatment | Health Plus | Studio N - Video - January 4th, 2014 [January 4th, 2014]
- Ayurvedic Remedy for Psoriasis - By Panditha Elchuri - Video - January 4th, 2014 [January 4th, 2014]
- Silica Gel For Psoriasis / Neurodermatitis - Video - January 4th, 2014 [January 4th, 2014]
- comment traiter son psoriasis détail oubliés - Video - January 4th, 2014 [January 4th, 2014]
- Psoriasis tends to relapse after stopping Methotrexate, shown in a case at Life Force - Video - January 4th, 2014 [January 4th, 2014]
- hiking nevada Health and Wellness Enthusiast Dawn Talks About Managing Plaque Psoriasis hiking watch - Video - January 5th, 2014 [January 5th, 2014]
- Guttate psoriasis - Wikipedia, the free encyclopedia - January 7th, 2014 [January 7th, 2014]
- Biofeedback May Help Control Stress-Related Diseases - January 8th, 2014 [January 8th, 2014]
- Psoriasis can be managed with proper treatment - January 10th, 2014 [January 10th, 2014]
- CNN anchor: How I fight psoriasis - January 10th, 2014 [January 10th, 2014]
- Psoriasis - My Home Remedies - January 10th, 2014 [January 10th, 2014]
- Psoriasis: MedlinePlus en español - January 10th, 2014 [January 10th, 2014]
- Psoriatic arthritis - Wikipedia, the free encyclopedia - January 10th, 2014 [January 10th, 2014]
- CNN anchor Zain Verjee: How I fight psoriasis - January 11th, 2014 [January 11th, 2014]
- Testimonio psoriasis - Video - January 14th, 2014 [January 14th, 2014]
- Heroin addict with severe Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- biospray for Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Psoriasis - Psoriasis Free For Life - Video - January 15th, 2014 [January 15th, 2014]
- 8 Cure For Scalp Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Learn about plaque psoriasis, guttate psoriasis, inverse ... - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Symptoms, Triggers, and Causes of Psoriasis on WebMD - January 16th, 2014 [January 16th, 2014]
- Psoriasis Causes, Symptoms, Treatments, Home Remedies - January 16th, 2014 [January 16th, 2014]
- Psoriasis Treatment - Dermasis Psoriasis Cream - My Honest Review - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Psoriasis Speaks Couple Looking At Rings In Jewelery Store Emotional - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Humira Psoriasis Medication Salon Clearer Skin is Possible - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis Symptoms, Causes and Treatment Pictures Slideshow - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Medscape Reference - January 19th, 2014 [January 19th, 2014]
- 5 Home Remedies For Scalp Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Ikonsulta Mo: Medical Advise on Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Patient Recruitment: Television Campaign for Severe Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Patient Recruitment: Television Campaign for resistant, summertime Mild to Moderate Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Dr stephen ferguson ND PhD chronic fatigue psoriasis cured - Video - January 23rd, 2014 [January 23rd, 2014]
- Noir Naturals Age of Innocence (Unscented) Goat's Milk Lotion for Psoriasis Relief - Video - January 23rd, 2014 [January 23rd, 2014]
- New biologic drugs offer relief for psoriasis sufferers - January 24th, 2014 [January 24th, 2014]
- Psoriasis traitement appliquer le lait pour le corps ISO UREA MD Vidéo La Roche Posay INFO PSO - Video - January 24th, 2014 [January 24th, 2014]
- Psoriasis - Video - January 24th, 2014 [January 24th, 2014]
- Coping with psoriasis - Video - January 26th, 2014 [January 26th, 2014]
- Exfoliative Dermatitis/Psoriasis Vulgaris with Psoriatic Arthritis with English Subtitles - Video - January 26th, 2014 [January 26th, 2014]
- Psoriasis skin care routine 2014 - Video - January 27th, 2014 [January 27th, 2014]
- How to treat psoriasis effectively - By Franziska Ringpfeil, Board Certified Dermatologist - Video - January 28th, 2014 [January 28th, 2014]
- My Psoriasis 411: Apple Cider Vinegar Tutorial for Scalp Treatment - Video - January 29th, 2014 [January 29th, 2014]
- 12 Best and Worst Foods for Psoriasis - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en radio Tagoror - Video - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en Canarias Hoy - Video - January 31st, 2014 [January 31st, 2014]
- Psoriasis Natural Treatment that Workswww savevid com - Video - January 31st, 2014 [January 31st, 2014]