Monthly Archives: June 2020

Treatment with tumor necrosis factor inhibitors (TNFis) vs methotrexate alone is not associated with a decreased risk for progression to psoriatic arthritis (PsA) in patients with psoriasis, according to study results presented at the European League Against Rheumatism (EULAR) 2020 E-Congress, held online from June 3 to 6, 2020.

To determine if treatment with TNFis vs methotrexate alone reduce the risk of developing PsA in patients with existing psoriasis, researchers from Oregon Health and Science University, School of Medicine, Portland, assessed data from all patients with psoriasis seen at their clinic from January 2006 to June 2019. Diagnosis of PsA was made by a rheumatologist. Continuous covariates and categoric covariates were compared by the Students t-test and Pearsons chi-squared test or Fishers test, respectively.

A total of 154 patients (51.3% women) with psoriasis who did not have PsA at baseline were included in the study. A TNFi was administered to 55.2% (n=85) and methotrexate to 44.8% (n=69) of the patients during the study period. Patients in the TNFi cohort received therapy for a mean duration of 3.950.50 years and patients in the methotrexate cohort had a mean duration of therapy of 1.930.28 years. Mean follow-up time was 5.180.49 years and 2.710.37 years for the TNFi and methotrexate cohorts, respectively.

During the study period, 22.7% of patients (n=35) developed PsA. After adjusting for propensity score, nail pitting, body surface area involved in psoriasis, and depression, the investigators found that treatment with TNFi did not significantly reduce the risk for PsA, as compared with treatment with methotrexate (HR, 0.68; 95% CI, 0.32-1.41).

Use of TNFi was not associated with a statistically significant decreased risk of incident PsA compared to methotrexate in this study, but a larger cohort with longer follow-up will have better power to estimate the true association, the researchers concluded.

Reference

Lininger N, Siegel S, Kiwalkar S, Winthrop K, Ortega Loayza A, Deodhar A. Do TNF inhibitors decrease risk of incident psoriatic arthritis in psoriasis patients compared to those treated with methotrexate alone? Presented at: EULAR 2020 E-Congress; June 3-6, 2020. Abstract FRI0555.

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Do TNFis Reduce the Risk for Progression to PsA in Patients With Psoriasis? - Rheumatology Advisor

The long-term safety and tolerability is consistent with the known safety profile of ixekizumab in multiple chronic inflammatory diseases, including psoriasis, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), according to study results published in Rheumatology.

Ixekizumab is a monoclonal antibody that targets interleukin-17A and is used for the treatment of several inflammatory diseases. In an integrated analysis of 21 clinical trials, the investigators aimed to characterize the long-term safety and tolerability of ixekizumab in patients with psoriasis, PsA, and axSpA.

Using data from randomized controlled trials, the researchers examined the rates of adverse events (AEs) and treatment-emergent adverse events (TEAEs), summarized by exposure-adjusted incidence rates, associated with ixekizumab use.

The pooled population included 8228 patients, of whom 5898 had psoriasis, 1401 had PsA, and 929 had axSpA. The percentage of men ranged from 48.5% to 69.9% in the analysis, with all groups including predominantly white patients (74%-91.3%). The cumulative exposure time was 20,895.9 person-years (PYs), with up to 5, 3 and 2 years of exposure for patients treated for psoriasis, PsA, and axSpA, respectively.

The overall incidence rates of patients with 1 TEAE were 29.5 per 100 PYs in the psoriasis group (86.6% of patients), 50.6 per 100 PYs in the PsA group (80.5% of patients), and 55.9 per 100 PYs in the axSpA group (80.4% of patients). Severe TEAEs were reported by 8.1% to 16.7% of patients across all groups. The most frequently reported events among all groups were nasopharyngitis (14.4%-25.7%), upper respiratory tract infections (10.5%-15.6%), and injection site reactions (9.7%-11.1%). The most commonly reported TEAEs of special interest were infections, including nasopharyngitis, upper respiratory tract infections, and bronchitis. Infections were most common during the first year, with incidence rates ranging from 49.5 to 56.6 per 100 PYs, and decreased over time to 40.1 per 100 PYs across all groups.

Major cardiovascular events, malignancies, and inflammatory bowel disease were rare, with incidence rates of <1 per 100 PYs across all groups. Serious adverse events were reported at an incidence rate of 5.4 to 6.0 per 100 PYs and remained stable over time. Discontinuation from the study due to adverse events was reported in <10% of patients in all groups.

Among the pooled population, 43 deaths were reported, including 35, 6, and 2 in the psoriasis, PsA, and axSpA groups, respectively. The predominant cause of death was major cardiovascular events in the psoriasis and PsA groups, though ixekizumab was not associated with individual causes of death.

The most significant limitation of the analysis included the survival bias that occurs in long-term study extensions, since only patients who continue to respond to treatment are enrolled in such studies.

Chronic diseases such as [psoriasis], PsA and axSpA require long-term treatment management. Therefore, long-term assessment of safety is needed to evaluate the benefit-risk of treatment, the researchers concluded. This long-term analysis on the safety of ixekizumab was consistent with previously published reports and did not show any new safety signals.

Disclosures: The clinical trial was supported by Eli Lilly and Company. Several authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.

Reference

Genovese MC, Mysler E, Tomita T, Papp KA, Salvarani C, Schwartzman S, et al. Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials [published online May 25, 2020]. Rheumatology (Oxford). doi:10.1093/rheumatology/keaa189

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Integrated Analysis Shows Long-Term Safety, Tolerability of Ixekizumab in Psoriasis, PsA, and axSpA - Rheumatology Advisor

Although previous studies suggest that psoriasis may be independently associated with an increased risk of serious infectionthat which leads to hospitalizationthe research had various limitations, and thus, the relationship remains unclear, explains Zenas Yiu, PhD. In a study published in the British Journal of Dermatology, Dr. Yiu and colleagues sought to determine if patients with psoriasis, when compared with those without the condition, have a higher risk of hospitalization due to any infection, respiratory infections, soft tissue and skin infections, or death due to infection.

Using data from the nationally representative UK Clinical Practice Research Datalink linked to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) mortality records between January 2003 and December 2016, the researchers matched adults with psoriasis with up to six comparators on age, sex, and general practice. Hospitalization due to infection was ascertained from HES records and death from ONS mortality records. Stratified Cox proportional hazard models were estimated, with stepwise adjustment in different models for confounding factors, including body mass index, smoking, alcohol intake, socioeconomic status, and comorbid conditions. Approximately 70,000 patients with psoriasis and nearly 340,000 comparators were followed for a median of about 5 years.

People with psoriasis had a higher incidence rate of serious infection, at 20.5 per 1,000 person-years, than the comparators, at 16.1 per 1,000 person-years, says Dr. Yiu. After adjustment, people with psoriasis had a 36% increased relative probability of developing a serious infection during follow-up compared with the general population (hazard ratio, 1.36). However, this only translated to three out of 100 more people with psoriasis developing a serious infection after 10 years of follow-up, compared with the general population.

Dr. Yiu notes that while patients with psoriasis were found to have a small but increased risk of serious infection when compared with those without the condition, because the absolute increased probability of serious infection is small, people with psoriasis should not be unduly concerned. We recommend further research to investigate whether this slight increase in the risk of infection can be explained by biological mechanisms.

Risk of Hospitalization and Death due to Infection in People with Psoriasis: a Populationbased Cohort Study using the Clinical Practice Research Datalinkhttps://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.19052

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Infection-Related Hospitalization & Mortality in Patients With Psoriasis - Physician's Weekly

AbbVie has submitted an application to the Food and Drug Administration (FDA) for review of upadacitinib in the treatment of active psoriatic arthritis (PsA) in adults.

The application is supported by data from two phase 3 studies (SELECT-PsA 1 and SELECT-PsA 2) that assessed the efficacy and safety of upadacitinib (15mg and 30mg) in more than 2000 adults with active PsA. SELECT-PsA 1 compared upadacitinib with placebo and adalimumab; SELECT-PsA 2 compared upadacitinib with placebo. The primary end point for both studies was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 12.

Results from SELECT-PsA 1 showed that upadacitinib 15mg and 30mg achieved noninferiority at week 12 compared with adalimumab, with the 30mg dose showing superiority. Both doses of upadacitinib achieved statistically significant ACR20, ACR50, and ACR70 responses at week 12 compared with placebo, along with significant improvements for key secondary end points, including the Health Assessment Questionnaire Disability Index (HAQ-DI), Psoriasis Area Severity Index (PASI 75), and Minimal disease activity (MDA).

Additionally, findings from SELECT-PsA 2 demonstrated both doses of upadacitinib achieved statistically significant ACR 20, ACR50, and ACR70 responses at week 12 compared with placebo. Both doses of upadacitinib also achieved statistically significant responses for PASI 75 and MDA compared with placebo.

With regard to safety, upadacitinib demonstrated a profile consistent with that seen in previous clinical studies.

Upadacitinib, a selective and reversible Janus Kinase (JAK) inhibitor, is currently marketed under the brand name Rinvoq and is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.

For more information visit abbvie.com.

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Upadacitinib Application for Active Psoriatic Arthritis Submitted for Review - Monthly Prescribing Reference

Novartis' Cosentyx lost a race against Eli Lilly's Taltz after the latter scored an FDA approval in spondyloarthritis earlier this week. But Cosentyx, which facesan FDA review in that indication, is touting long-term data that will help it keep the pressure on Lilly's rival.

The drugbestedplacebo atreducing the symptoms ofnon-radiographic axial spondyloarthritis in patients after 52 weeks, according to long-term data from the phase 3 Prevent study released Thursday at the European League Against Rheumatology (EULAR)meeting.

The 52-week data adds to earlier 16-week data that showed Cosentyx significantly reduced disease symptoms over placebo. More than 35%of patients treated with Cosentyx hit the study's primary endpoint of reducing a targeted set of disease symptoms at 52 weeks compared with 19% of patients taking placebo. At 16 weeks, 42.2% of patients hit the same markversus 29.2% for placebo.

Cosentyx notched a European MedicinesAgency approval to treat non-radiographic axial spondyloarthritis in April and has already filed for regulatory approval in the U.S. and Japan.

The newest Cosentyx data will keep things competitive with Lilly's Taltz, which scored an FDA approval earlier this week as the first IL-17 inhibitor green-lighted in that indication.

RELATED:Eli Lilly's Taltz beats Novartis to the punch with FDA approval in spondyloarthritis

Taltz won its approval based onresults from the phase 3 Coast-X trial, which showed 30% of patients treated with Taltz saw reduced targeted disease symptoms after 52 weeks of treatment compared with 13% of patients treated with placebo.

At 16 weeks, 35% of Taltz patients stayed above that mark compared with 19% of placebo patients.

Non-radiographic axial spondyloarthritis is believed to affect more than 1 million U.S. patients each year, Lilly said.An FDA approval for Cosentyx would be the drug'sfourth, as it was for Taltz; both drugs are also cleared in psoriatic arthritis, ankylosing spondylitis and psoriasis.

In March, UCBs anti-TNF antibody Cimzia became the first FDA-approved drugfor non-radiographic axial spondyloarthritis. But that drug carries a boxed warning about the increased risk of serious infections.

RELATED:Novartis' Cosentyx can't top AbbVie's Humira in head-to-head psoriatic arthritis contest

Lilly and Novartis are not only jockeying for position in spondyloarthritis. The companies are also battling it out across their other indications.

In June, Lilly posted head-to-head phase 3 trial data showing TaltzbestedAbbVie's megablockbuster Humira at reducing psoriatic disease activity by half and completely clearing patient skin after 24 weeks. Lilly also went after Johnson & Johnson's Tremfya in psoriasis with a round of phase 4 data, showing in early August its drug hadtoppedTremfya at achieving total skin clearance after 12 weeks of treatment.

Meanwhile, Cosentyx posted middling results in November in a head-to-head matchup with Humira,failing to outdo AbbVie's behemothin active psoriatic arthritis patients.

While Cosentyx helped more patients numerically reach ACR20a benchmark on a commonly used scale from the American College of Rheumatology to measure joint swelling and moreits lead wasnt statistically relevant, Novartis said.

Editors' Note: This story has been updated to correct an error.

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Novartis' Cosentyx chases Lilly's just-approved Taltz with long-term data in spondyloarthritis - FiercePharma

The challenges of the COVID-19 pandemic have spurred many marketers to create reassuring and empathetic TV ads, including some pharma companies. Several pharmas have adjusted TV strategies to run, along withtypical DTC or disease awareness commercials, ads that offerthanks to frontline healthcare workers ordetails about help to payfor medicine.

AbbVie is leading the way in televised financial support messages, starting with the Humira and Rinvoq brands. The pharma added messages to the end of those ads directed at people who have lost jobs or insurance during the crisis, with re-directs to where they can find assistance.

For Skyrizi, its newer-to-the-airwaves psoriasis medication, AbbVie created an entirely new spot talking about the challenging times and the potential for financial help. The commercial, which aired several times during the popular ESPN Sunday night series The Last Dance about basketball star Michael Jordan, speaks directly to patients who take Skyrizi, telling them financial assistance may be available to help you afford your medication.

RELATED:Pharma ups April TV spending for stuck-at-home viewers with AbbVie leading the way

The TV ads are part of the Illinois drugmaker'sbroader efforts to help patients continue to get their medications,AbbVie said in an emailed statement.

AbbVie understands this is a difficult time for patients affected by the COVID-19 crisis, and we are here to support them. Patients access news in a variety of ways, so AbbVie has updated television spots with COVID-19 support information, in addition to newspaper and social media ads to help increase awareness about our patient assistance resources, the statementsaid.

Other pharma companies offering financial assistancethat may be especially needed during the pandemic include Novo Nordisk for its diabetes brand Ozempic, Novartis for psoriasis med Cosentyx and Sunovion for bipolar depression treatment Latuda.

Some other pharma companies joined the broader thank you-themed TV ad trend that many brands have adopted. Marketers from Google and McDonalds to Dove and Glad are airing commercials expressing appreciation and pledging donations to help.

Pfizer, Amgen and Johnson & Johnson all created TV ads with messages of gratitude to people helping in the fight against COVID-19and offered hope for the future. Novartis also included thank-yous to heroic healthcare workers in a commercial for heart failure medicine Entresto as well as in the Cosentyx Connect financial assistance ad.

RELATED:AstraZeneca tackles COPD, asthma patients' COVID-19 concerns in new YouTube series

While the new ads offer help and hope, theyre also likely reaching more viewers. During the pandemic, the number of TV watchers has grown for the first time since 2012, according to market researcher eMarketer. It predicts an increase of 3% in TV viewer growth for the year, driven by stay-at-home orders during COVID-19, after more than seven years of single-digit slides. Still, the trend may not last for longeMarketer predicts a reversal in 2021 and an overall dip again next year.

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AbbVie, Pfizer, Novartis and more air TV ads to offer COVID-19 thank-you's, support - FiercePharma