Patients with psoriatic arthritis showed long-term efficacy and safety with Cimzia by achieving Disease Activity Index for Psoriatic Arthritis minimal disease activity and very low disease activity in the 4-year RAPID-PsA phase 3 trial, according to results presented at the European Academy of Dermatology and Venereology Congress.
“These new data further confirm the durability profile of Cimzia treatment in both psoriasis and psoriatic arthritis,” clinical study investigator Andrew Blauvelt, MD, MBA, president and investigator, Oregon Medical Research Center, told Healio Dermatology. “Long-term data such as these are helpful to guide clinical decision-making for patients hoping to have meaningful results that endure over time.”
The RAPID-PsA trial was double-blind and placebo-controlled to week 24, dose-blind to week 48 and open-label to week 216, according to the study abstract.
Two hundred seventy-three patients were randomly assigned to Cimzia (certolizumab pegol, UCB) 200 mg every 2 weeks or 400 mg every 4 weeks until week 216. Patients received a loading dose of certolizumab pegol 400 mg at weeks 0, 2 and 4.
Researchers assessed psoriatic arthritis severity using seven minimal disease activity (MDA) criteria: tender joint count of 1 or less, swollen join count of 1 or less, Psoriasis Area and Severity Index (PASI) of 1 or less or body surface area affected (BSA) of 3% or less, patient pain Visual Analogue Score (VAS) of 15 or less, patient global disease activity VAS of 20 or less, Health Assessment Questionnaire Disability Index of 0.5 or less, and tender entheseal points of 1 or less.
At baseline, 166 patients had BSA of 3% or greater; 39 of these patients achieved MDA plus BSA of 3% or less at week 24.
At week 24, 95 patients achieved MDA and 37 patients achieved very low disease activity (VLDA).
“The greatest durability observed was for MDA, but VLDA and MDA plus body surface area 3% were sustained to week 216 in over 80% of week 24 responders,” Blauvelt said. – by Abigail Sutton
Gottlieb AB, et al. Durability of response in patients with psoriatic arthritis treated with certolizumab pegol over 216 weeks: Post hoc analyses from the RAPID-PsA study. Presented at: 28th European Academy of Dermatology and Venereology Congress; Oct. 9-13, 2019; Madrid.
Disclosure: Blauvelt reports he is a scientific consultant and clinical study investigator for UCB.