Studies added to the knowledge base of biosimilars for psoriasis, HS

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A cohort study of psoriasis patients in Denmark found that a non-medical change of brand was being made adalimumab in adalimumab biosimilars was not associated with drug retention after one year. And another study, a small retrospective study of a single patient center with suppurative hydradenitis (HS), found that the administration of infliximab and biosimilar infliximab were associated with a similar and significant improvement in the disease.

Both studies were published online in April in JAMA Dermatology and add to the evidence that biosimilars can be interchangeable under certain dermatological conditions.

“Biosimilars are an exciting innovation in the field,” Joseph Zahn, MD, said in an interview the assistant professor of dermatology at George Washington University, Washington. “Its effectiveness and price will allow patients greater access to effective treatment.” To date, U.S.-approved biosimilars that could be prescribed by dermatologists include biosimilars. rituximab, etanercept, adalimumab and infliximab.

A la test of Denmark, Nikolai Loft, MD, of the University of Copenhagen and colleagues evaluated the results after a mandatory medical change of the brand name adalimumab, called the originator of adalimumab, to biosimilars of adalimumab between 726 people who were enrolled in a nationwide Danish patient registry treated with biologics since 2007. The main outcome was drug retention for one year in patients who switched to adalimumab biosimilar compared to patients treated with originator of adalimumab.

The study population consisted of 348 patients with at least 2 years of adalimumab exposure who had switched from original biosimilars to adalimumab (a mean age of 52 and 72% male) and 378 patients who served as a cohort of adalimumab. adalimumab (mean age 51 years) and 71% male). When the researchers compared the one-year drug retention rates between the adalimumab biosimilar cohort and the adalimumab-originating cohort, the rates were similar (92% vs. 92.1%, respectively).

The hazard ratios for other results were also similar. Specifically, the gross hazard ratios were 1.02 (Pg = 0.94) for all causes of drug discontinuation, 0.82 (Pg = 0.60) for insufficient effect and 1.41 (Pg = .50) for adverse events (ADs) in the adalimumab biosimilar cohort, compared with the adalimumab-originating cohort.

“In general, the results of any EA were contradictory, but certain AEs were more common in the adalimumab biosimilar cohort,” the authors wrote. Dermatological EAs and EAs in the “other” category were more prevalent, which could be attributed to more patients experiencing injection site reactions as a result of higher volumes and differences in excipients and syringes in the biosimilars of the ‘adalimumab and the origin of adalimumab.’ Other potential explanations they offered were the nocebo effect and increased awareness of EAs among professionals and patients.

“This study concludes that when switching to a biosimilar drug, patients do not have worse control of their psoriasis nor do they switch to other drugs,” Zahn, who was asked about these results, said in the interview. “However, there was a trend toward a greater number of side effects in the biosimilar group. The main highlight of this study is that adalimumab biosimilars appear to be relatively interchangeable in patients with psoriasis without loss of efficacy or significant increase in side effects leading to a change in medication for the patient. “

The researchers acknowledged certain limitations of their study, including the fact that it was limited to Danish patients and that individual AE could not be examined. “Furthermore, surveillance of EAs is not as vigilant as in clinical trials and EA is unlikely to be notified,” they wrote. “Although no significant differences were found when switching from the original adalimumab to the biosimilar versions of adalimumab, the performance of the individual biosimilar versions of adalimumab could not be assessed in this study.”

In the second to study, Christopher Sayed, MD, associate professor of dermatology, University of North Carolina, Chapel Hill, and colleagues retrospectively evaluated the efficacy of infliximab-abda versus infliximab administration in the treatment of 34 HS patients treated at the dermatology clinic of the university. Patients were treated with any agent for at least ten weeks. The infliximab treatment group consisted of 20 patients with a mean age of 42 years mostly female (17; 85%), while the infliximab-abda treatment group included 14 patients with a mean age of 36 years who were also female. mostly women (13; 93%).

Both groups received loading doses of 10 mg / kg at weeks 0, 2, and 6, and treatment was continued with a maintenance dose administered every 4-8 weeks. Patients were followed between February 2016 and June 2020 and the main measure of outcome was the clinical suppurative response of hydradenitis (HiSCR), which was defined as at least 50% in the increase in uninfected inflammatory nodules. the number of abscesses or draining sinuses.

The researchers found that 71% of patients in the infliximab-abda treatment group achieved a HiSCR, compared with 60% of their infliximab treatment group counterparts, a difference that did not reach statistical significance (Pg = .47). Three patients in the infliximab treatment group experienced EA, compared with none in the infliximab-abda treatment group.

“The data is promising,” Zahn said. “Although this is a small study with a limited number of patients, it suggests that this particular biosimilar may be a reasonable alternative or even equivalent to infliximab. A larger, more prospective trial will be needed before having the certainty that the results are equivalent. “

Sayed and colleagues noted certain limitations of their study, including retrospective design and the use of concomitant medications by some participants. “There is also a risk of selection bias because copayments and drug assistance programs are not available for infliximab-abda for patients with HS,” they wrote.

In a editorial accompanying the two studies, Mark Lebwohl, MD, professor of dermatology, Icahn School of Medicine in Mount Sinai, New York, wrote that the introduction of biosimilars has been justified by “the hope that lower costs” will increase the availability of treatments for patients with moderate to severe psoriasis. severe. “However, incidences in the U.S. market have been limited,” he added, and is concerned that “they may be used to prevent access to new interleukin-17 blockers and interleukin-23 blockers for which biosimilars are available and do not carry the box warnings found in tumor necrosis factor blockers “.

Loft reported receiving personal fees from Eli Lilly and Janssen outside of the work presented. Many of its co-authors reported having numerous financial conflicts of interest with the pharmaceutical industry. The SA study was supported by a research award in public health services from the National Institutes of Health. Sayed reported that he had received personal fees or personal fees paid to the institution by AbbVie, Novartis, Chemocentryx, GlaxoSmithKline, Incyte, InflaRx and UCB. No other disclosures were reported. Lebwohl revealed the receipt of research funding from companies such as AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly and Incyte; and receive personal fees from various companies, outside of the work submitted. Zahn reported that he had no disclosures.

This article originally appeared on MDedge.com, which is part of the Medscape professional network.





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