Certolizumab pegol (CZP) may be safe and effective in the long-term treatment of psoriatic arthritis (PsA), according to a post hoc analysis presented at the 28th European Academy of Dermatology and Venereology Congress, held October 9 to 13, 2019, in Madrid, Spain.
Researchers presented 4-year data from the RAPID-PsA trial (ClinicalTrials.gov Identifier: NCT01087788) that evaluated the long-term safety and efficacy of CZP in PsA.
RAPID-PsA, a double-blind, placebo-controlled trial to 24 weeks, dose-blind to 48 weeks, and open-label to 216 weeks, included data from patients with active PsA and failed previous treatment with ≥1 disease-modifying antirheumatic drug. All patients received a loading dose of CZP 400 mg at weeks 0, 2, and 4, and were randomly assigned to receive either CZP 200 mg every 2 weeks or 400 mg every 4 weeks. These assigned doses were continued up to week 216.
In this analysis, data from patients receiving CZP 200 mg or 400 mg were collected, and PsA severity was assessed by 7 minimal disease activity criteria: tender and swollen joint counts ≤1, Psoriasis Area Severity Index ≤1 or body surface area affected ≤3%, patient pain visual analog score ≤15, patient global disease activity visual analog score ≤20, Health Assessment Questionnaire Disability Index ≤0.5, and tender entheseal points ≤1.
In total, 273 patients were randomly assigned to receive either dose of CZP at baseline. At 24 weeks, 95 patients achieved minimal disease activity, and 37 achieved very low disease activity. At baseline, 166 patients had an affected body surface area ≥3%; 39 of these patients achieved minimal disease activity plus affected body surface area ≤3% at 24 weeks.
For all 3 composite outcome measures, patient response rates remained high up to week 216 in patients who had a response at week 24.
“In this analysis, a high [percentage] of patients [treated with CZP] demonstrated durability of their initial week 24 response to week 216,” the researchers concluded. “The greatest durability was observed for [minimal disease activity], although both [very low disease activity] and [minimal disease activity] plus [body surface area] ≤3% were achieved by over 80% of week 24 responders at week 216.”
Disclosure: This clinical trial was supported by UCB Pharma. Please see the original reference for a full list of authors’ disclosures.
Gottlieb AB, Gisondi P, Eells J, Peterson L, Kavanaugh A. 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; October 9-13, 2019; Madrid, Spain. Abstract #P0432.