Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study

• Published in: Journal of the American Academy of Dermatology Vol. 76; no. 6; pp. 1093 - 1102
• Main Authors: Papp, Kim, Bachelez, Herve, Costanzo, Antonio, Foley, Peter, Gooderham, Melinda, Kaur, Primal, Narbutt, Joanna, Philipp, Sandra, Spelman, Lynda, Weglowska, Jolanta, Zhang, Nan, Strober, Bruce
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2017
• Subjects: ABP 501; adalimumab; Adalimumab - therapeutic use; Adult; biosimilar; Biosimilar Pharmaceuticals - therapeutic use; Dermatology; Double-Blind Method; efficacy; equivalence; Female; Humans; Male; Middle Aged; psoriasis; Psoriasis - drug therapy; safety; Severity of Illness Index; PASI 90; equivalence; PASI; PASI 50; CI; PASI 75; TNF; ABP 501; adalimumab; efficacy; PASI 100; TEAE; psoriasis; safety; SAE; ADA; biosimilar; 50% or more improvement in Psoriasis Area and Severity Index score from baseline; treatment-emergent adverse event; Psoriasis Area and Severity Index; 100% improvement in Psoriasis Area and Severity Index score from baseline; 75% or more improvement in Psoriasis Area and Severity Index score from baseline; serious adverse event; 90% or more improvement in Psoriasis Area and Severity Index score from baseline; antidrug antibody; tumor necrosis factor; confidence interval

ABP 501 is a biosimilar of adalimumab. We sought to compare the efficacy and safety of ABP 501 with adalimumab. This 52-week, double-blind study randomized patients with moderate to severe psoriasis to ABP 501 or adalimumab. At week 16, those with 50% or more improvement in Psoriasis Area and Severi...