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Background   EGALITY  was a phase  III  confirmatory efficacy and safety study conducted in patients with plaque‐type psoriasis as a part of totality of evidence gathered during the development of  GP 2015, an etanercept biosimilar.    Objective  To demonstrate equivalent efficacy and comparable safety and immunogenicity of  GP 2015 and the etanercept originator product ( ETN , Enbrel ® ) and evaluate effects of repeated switching between  GP 2015 and  ETN . Results for efficacy, safety and immunogenicity during treatment period ( TP ) 2 ( TP 2) are presented pooling the two continued treatment arms (pooled continued) versus the two treatment arms with repeated switches (pooled switched).    Methods  Patients ( n  = 531) were randomized 1:1 to self‐administer  GP 2015 or  ETN  twice‐weekly subcutaneously during  TP 1. Patients with a ≥50% improvement in Psoriasis Area and Severity Index ( PASI  50) at week 12 were re‐randomized for  TP 2 to continue the same treatment at once‐weekly dosing or to undergo three consecutive treatment switches between  GP 2015 and  ETN  until week 30. Patients continued the last‐assigned treatment during  TP 2, until week 52.    Results  Mean (standard deviation [ SD ])  PASI  scores at baseline were similar in patients who underwent multiple switches compared to those with continued treatments during  TP 2. During  TP 2,  PASI  50,  PASI  75 and  PASI  90 response rates, percent change from baseline in  PASI  scores and all other efficacy parameters were similar between the pooled switched and pooled continued treatment groups at all time points. The incidence of treatment‐emergent adverse events including injection site reactions was comparable between the pooled switched (36.7%) and pooled continued (34.9%) groups. None of the patients in either treatment group were positive for binding anti‐drug antibodies in  TP 2.    Conclusion  Treatment efficacy, safety and immunogenicity were similar between the pooled continued and pooled switched treatments during  TP 2, indicating that there are no effects in the short term on clinical data of multiple switches between  GP 2015 and  ETN .

journal of the european academy of dermatology and venereology

Multiple switches between  GP 2015, 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