Over the course of 4 years, patients with psoriatic arthritis (PsA) taking certolizumab pegol (CZP) as monotherapy or in combination with disease-modifying antirheumatic drugs (DMARDs) demonstrated clinical improvement compared with those taking placebo, according to a report published in Clinical Rheumatology.
For individuals with inadequate responses to DMARD therapy, the addition of biologic medications, such as CZP, can improve treatment outcomes, whereas CZP monotherapy should be considered for patients in whom conventional DMARDs are contraindicated. Although there is available information regarding the efficacy of biologics with and without DMARDs, there has been limited investigation of similar comparisons involving CZP.
The RAPID-PsA trial (ClinicalTrials.gov identifier: NCT01087788) was a 216-week, multicenter, phase 3 randomized clinical trial. At baseline, patients with active PsA with a history of at least 1 DMARD failure were randomly assigned to receive CZP 200 mg every other week, CZP 400 mg every 4 weeks, or placebo. Patients who were randomly assigned to receive CZP continued their dose into the open-label segment.
American College of Rheumatology 20% improvement (ACR20) was the primary end point and was accompanied by other outcome indices assessing dactylitis, enthesitis, and psoriasis, as well as health-related quality of life, using the Health Assessment Questionnaire Disability Index (HAQ-DI).
Of 409 total participants, 273 were assigned to receive CZP from baseline, divided according to DMARD use. A total of 199 patients were positive for DMARD use (mean age, 48.4 years; 53.3% women; 98.0% white), and 74 did not use DMARDs (mean age, 45.9 years; 55.4% women; 98.6% white). At 216 weeks, 70.9% DMARD-positive and 56.8% DMARD-negative patients had completed the study, with 79.7% of DMARD-positive individuals and 83.3% of DMARD-negative patients achieving ACR20 responses by the end of the study.
Nearly 80% of patients in each subgroup saw a 75% improvement on the Psoriasis Area and Severity Index, and a high percentage of patients with extra-articular manifestations reported total resolution by 216 weeks. In terms of dactylitis and enthesitis, 91.4% and 74.4% of DMARD-positive and 93.3% and 87.5% of DMARD-negative patients showed improvements, respectively.
The HAQ-DI had a minimal clinically important difference of at least a 0.35-point reduction from baseline, which was achieved by 58.7% and 69.0% of DMARD-positive and DMARD-negative patients, respectively, by 216 weeks. Overall safety profiles were similar for the 2 subgroups, with serious treatment-emergent adverse events occurring in 26.2% of DMARD-positive and 23.7% of DMARD-negative patients.
Study limitations included initial classification of participants with or without DMARD use without accounting for any changes in usage during the study period. Additional limitations included lack of control or randomization by DMARD status, lack of formal comparisons between DMARD subgroups, and a risk for bias secondary to patient withdrawal.
“Our study has shown sustained improvements in signs and symptoms of PsA whether patients’ treatment was with CZP alone or in combination with DMARDs,” observed the authors.
“These findings are of particular importance for those patients who are unable or unwilling to take DMARDs.”
Please see original article for funding information and conflict-of-interest disclosures.
Walsh JA, Gottlieb AB, Hoepken B, Nurminen T, Mease PJ. Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial [published online September 6, 2018]. Clin Rheumatol. doi: 10.1007/s10067-018-4227-7