ADACCESS Phase III study of GP 2017 (biosimilar adalimumab) matches the originator medicine to treat plaque psoriasis.- Sandoz.
Sandoz,announces new data on its proposed biosimilar adalimumab. Data from a long-term study of patients continuously treated with the proposed biosimilar or the reference medicine show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis. Results were presented at the 26th Congress of the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland.
About the study : ADACCESS (NCT02016105) is a Phase III confirmatory randomized, double-blind, controlled, 51-week study to compare efficacy and safety between Sandoz biosimilar adalimumab and the reference medicine. The study consists of three treatment periods. During the first 17-week treatment period, eligible patients with active, but clinically stable, moderate-to-severe chronic plaque psoriasis were randomized to receive either biosimilar adalimumab or its reference medicine. In the second period, patients were re-randomized into four groups; the first two groups continued with their originally assigned treatment and the other two switched to alternating treatment every six weeks until Week 35. In the third period, patients received their initially assigned treatment up to Week 51.
The Phase III confirmatory study demonstrates that Sandoz biosimilar adalimumab matches the reference medicine in terms of efficacy and safety up to Week . Psoriasis Area and Severity Index 75 (PASI 75) response rates for patients who received biosimilar adalimumab continuously throughout the study were 75.2% at Week 17 and 84.5% at Week 51, compared with 67.8% at Week 17 and 79.6% at Week 51 for patients who received continuous treatment with the reference medicine. PASI 75 response represents an improvement of at least 75% in the severity of a patient's psoriasis. Investigator's Global Assessment (IGA) response rates were also similar between the two groups in the study throughout the 51 weeks. There were no clinically relevant differences in adverse events between the two treatment groups, and the immunogenicity profiles were similar.
Comment: GP 2017 has been accepted for regulatory review by the EMA in June 2017.
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