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At week 16, no significant differences in response rates were observed regarding the adalimumab biologic and biosimilars.
Results of a systematic assessment of adalimumab biosimilar agents in patients with moderate-to-severe plaque psoriasis revealed a similar efficacy and safety profile compared with the reference product among this patient population, according to a study published in Journal of Dermatological Treatment.1
Psoriasis, a common immune-mediated inflammatory disease, can impact the quality of life, mental health, and appearance of a patient, including clinical manifestations called plaques which can be either localized or widespread. Previous research on reference adalimumab has been shown to be safe and effective in treating both moderate-to-severe plaque psoriasis and psoriatic arthritis.2
“Once the patent protection of the adalimumab-antigen drug adalimumab (Humira) expired, many pharmaceutical companies performed research to develop its biosimilars,” wrote a group of Chinese investigators. “There are now various adalimumab biosimilars on the market in China and other countries which are significantly cheaper and more accessible than adalimumab. However, it is vital to know if the efficacy and safety of adalimumab biosimilar agents differ from those of their reference agents in the treatment of psoriasis.”
In the systematic review, investigators searched databases including PubMed, Cochrane Library, China National Knowledge Internet (CNKI), Embase, and WanFang, from inception through April 2022 to evaluate the efficacy and safety of adalimumab biosimilars. Eligible studies were randomized controlled trials (RCTs) which assessed the biosimilars compared with the reference product in the treatment of moderate-to-severe plaque psoriasis. Patients were categorized by intervention plan and intervention time and received an initial dose of 80 mg of the applicable study drug in week 1, followed by a 40 mg dose every other week until week 16. Those who completed 16 weeks of treatment entered stage 2 and received either the biosimilar or the reference drug until the treatment cycle was completed.
Seven RCTs, involving 2589 patients, were included in a meta-analysis, with 1295 cases in the experimental cohort and 1294 cases in the control cohort. At the 16-week mark, no significant differences in response rates were observed regarding the adalimumab biologic and the biosimilars. Response was defined as a 75% decrease in the Psoriasis Area and Severity Index (PASI 75; P >.05), PASI 50, PASI 90, and PASI 100 (P > .05).
Additionally, there was no significant difference in the incidence rate of serious adverse events (SAEs) between both cohorts and weeks 16 and 24 (P >.05). The withdrawal rate due to SAEs and treatment-emergent adverse events (TEAEs), which were compared in 4 of the RCTs, were not significantly different among both groups at week 16, week 24, and week 51 after treatment initiation (P >.05). Regarding the adverse events of special interests, no statistical heterogeneity was reported among both treatment groups during the first 16 weeks of treatment.
Investigators noted limitations of the analysis including the small number of included studies, as well as the relatively small number of included subjects. Therefore, they encouraged further multicenter, large-sample trials. Additionally, the short analysis period of studies may not be adequate to capture the complete disease cycle of the complex, chronic condition. Lastly, there is a possible risk of bias for SAEs and TEAEs due to the limited reference value.
“Adalimumab biosimilar agents are cheaper than their reference agents, which therefore makes them good choices for patients,” investigators emphasized. “These results support adalimumab biosimilar agents as an effective and affordable option for patients with moderate-to-severe plaque psoriasis.”