ABP 501, adalimumab biosimilar, safe and effective, for psoriasis
Kim Papp, M.D., Ph.D., from Clinical Research and Probity Medical Research in Waterloo, Canada, and colleagues randomized 308 patients (1:1) to receive ABP 501 or adalimumab (40 mg) every two weeks for 16 weeks. At week 16, patients with at least 50 percent improvement from baseline in psoriasis area-and-severity index score (PASI) were eligible to continue to Week 52 (152 patients), whereas adalimumab patients were re-randomized (1:1) to continue adalimumab (79 patients) or undergo a single transition to ABP 501 (77 patients).
The researchers found that PASI percent improvements were similar across groups for weeks 16, 32, and 50 (range, 85.8 to 88.2 percent), with no significant differences across groups in percentages of PASI 50, 75, 90, and 100 responders. Similarly, changes in percent body surface area affected were similar across groups and timepoints. There were no new safety issues reported, with adverse events similar between the groups.
"ABP 501 and adalimumab have similar clinical efficacy, safety, and immunogenicity profiles over 52 weeks, including after single transition, in this patient population," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Amgen, which manufactures ABP 501 and funded the study.
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