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Positive Results Reported With Adalimumab Biosimilar in Treatment of Plaque Psoriasis

Clinical equivalence demonstrated in phase III study

A phase III trial evaluating the efficacy and safety of the biosimilar candidate ABP 501 (Amgen) compared with adalimumab (Humira, AbbVie) in patients with moderate-to-severe plaque psoriasis has met its primary endpoint — the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment.

At week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared with adalimumab. In addition, the safety and immunogenicity of ABP 501 were comparable with that of adalimumab. This is the first of two phase III studies intended to form the basis for global regulatory submissions for ABP 501.

ABP 501 is being developed as a biosimilar to adalimumab, an anti–tumor necrosis factor (TNF)-alpha monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. The active ingredient in ABP 501 is an anti–TNF-alpha monoclonal antibody that has the same amino acid sequence as that of adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab in the U.S.

The new phase III, randomized, double-blind, active-controlled study evaluated the safety and efficacy of ABP 501 compared with that of adalimumab in adults with moderate-to-severe plaque psoriasis. A total of 350 patients were enrolled. Among these subjects, 174 in the ABP 501 group and 173 in the adalimumab group were treated. The trial’s primary endpoint — the PASI percent improvement — was evaluated at week 16. The PASI is a measure of the average erythema, induration, and scaling of the lesions (each graded on a severity scale of 0 to 4, and weighted by the area of involvement).

Patients with a PASI 50 or greater response at week 16 will remain in the study for up to 52 weeks. Patients continuing in the study beyond week 16 were re-randomized in a blinded fashion such that all patients initially assigned to receive ABP 501 continued to receive that treatment, and those given adalimumab either continued on adalimumab or switched to ABP 501. Patients will continue on treatment until week 48, when they will receive the last dose of the investigational product. The final efficacy assessments will be conducted at week 50, and the study will end at week 52.

Psoriasis is a non-contagious chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Instead of being shed, skin cells pile up, causing painful and itchy, red, scaly patches. Approximately 125 million people worldwide have psoriasis, and 80% of those patients have plaque psoriasis.

Source: Amgen; October 8, 2014.

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