Adalimumab biosimilar safety, efficacy matches Humira through 51 weeks

A biosimilar of adalimumab was associated with similar safety and efficacy outcomes compared with Humira in a cohort of patients with chronic plaque psoriasis, according to a company-issued press release.

Results of the study were presented at the European Academy of Dermatology and Venereology Annual Congress in Geneva.

The phase 3 randomized, double-blind, controlled, 51-week study included a 17-week initial treatment period for patients with clinically stable but active moderate to severe disease. Patients were treated with the novel adalimumab biosimilar therapy (Sandoz) or the originator Humira (adalimumab, AbbVie). The second period saw the patients randomly assigned again to one of four treatment groups: Two groups continued their originally assigned treatment, while two underwent alternating therapy between the novel drug and the originator drug every 6 weeks until week 35, according to the release. For the third study period, patients were returned to their initial assignment through week 51.

Results were assessed using the Psoriasis Area and Severity Index 75 (PASI 75). Week 17 results showed that 75.2% of patients treated continuously with the biosimilar therapy and 67.8% of those treated with the originator adalimumab reached PASI 75 response rates. At week 51, those rates were 84.5% for the biosimilar arm and 79.6% for the originator arm.

Other findings indicated similar Investigator's Global Assessment response rates for the biosimilar and the originator therapies during the 51 weeks.

Adverse events for the two drugs were comparable, as were immunogenicity profiles, according to the results.

The European Medicines Agency is currently reviewing the biosimilar therapy for the treatment of plaque psoriasis and other immunological conditions. – by Rob Volansky

Reference :

Blauvelt A, et al. A phase III confirmatory study comparing GP2017 with reference adalimumab in patients with moderate-to-severe chronic plaque psoriasis: 51 week results from the ADACCESS study. Presented at: European Academy of Dermatology and Venereology Annual Congress; September 13-17, 2017; Geneva.

Disclosures: This study was sponsored by Sandoz. Schuck, Jauch-Lembach, and Balfour report being paid employees of Hexal AG, a Sandoz company. Leonardi reports serving as a consultant for Sandoz.