Switching Between Etanercept Biosimilar, Original Safe for Plaque Psoriasis
The EGALITY study showed that frequent switches at short intervals between the originator and the biosimilar agent had no negative impact on efficacy, immunogenicity, or safety.
A recent study reported that etanercept (ETN) biosimilar GP2015 and the ETN original product are similar in efficacy, safety, and immunogenicity in patients with chronic plaque psoriasis, according to results published in the Journal of the European Academy of Dermatology and Venereology.
In the phase 3 comparator EGALITY study, a total of 531 patients were randomly assigned to self-administer GP2015 or ETN subcutaneously twice weekly during treatment period 1 (TP1). Patients who demonstrated a ≥50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 12 were randomly assigned again to treatment period 2 (TP2), either to continue the same therapy with once-weekly dosing or to undergo 3 consecutive treatment switches between GP2015 and ETN until week 30. During TP2, all patients continued the last assigned treatment until week 52. Study results were reported by pooling the 2 continued treatment groups (pooled continued arms; no treatment switches) with the 2 treatment groups that underwent repeated switches (pooled switched arms).
During TP2, mean PASI scores were similar in patients who underwent multiple switches and patients with continued treatment. PASI 50, PASI 75, and PASI 90 response rates, as well as percent change from baseline and all additional efficacy parameters, were similar in the pooled switched and pooled continued treatment groups in TP2. Moreover, the incidence of adverse events, such as injection-site reactions, was comparable in the pooled switched and pooled continued arms (36.7% vs 34.9%, respectively). None of the patients in either TP2 treatment group tested positive for binding antidrug antibodies.
Similar efficacy was reported with both continued therapy with 1 of the 2 agents and alternating treatment between GP2015 and ETN. “Switching between an originator and a biosimilar is expected to become common practice in real-life situations [and] the EGALITY study has shown that frequent switches at short intervals between GP2015 and ETN had no negative impact on efficacy, immunogenicity, and safety during the reported period,” the researchers concluded.
Gerdes S, Thaçi D, Griffiths CEM, et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study [published online September 28, 2017]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.14605.