Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4\xa0years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial

J A Walsh,A B Gottlieb,B Hoepken,T Nurminen,P J Mease

doi:10.1007/s10067-018-4227-7

J A Walsh, A B Gottlieb + Show 3 more

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https://doi.org/10.1007/s10067-018-4227-7

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Journal: Clinical Rheumatology	Publication Date: Sep 6, 2018
Citations: 15	License type: open-access

Affiliation: UCB Pharma (Germany)

Abstract

To report long-term efficacy of certolizumab pegol (CZP) treatment with and without concomitant DMARDs in patients with psoriatic arthritis (PsA). RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 216. Patients had active PsA with ≥ 1 failed DMARD. At baseline, patients were randomized 1:1:1 to CZP 200 mg every 2 weeks: CZP 400 mg every 4 weeks: placebo. CZP-randomized patients continued their dose into open-label. Observed case efficacy data are reported to week 216 for week 0 CZP-randomized patients (dose combined) with and without baseline DMARD use (DMARD+/DMARD−). Dactylitis (tenderness and ≥ 10% difference in swelling between affected and opposite digits) and enthesitis were measured using Leeds Dactylitis Index (LDI) and Leeds Enthesitis Index (LEI). 273/409 randomized patients received CZP from baseline: 199/273 (72.9%) DMARD+ and 74/273 (27.1%) DMARD− patients. 141/199 (70.9%) DMARD+ and 42/74 (56.8%) DMARD− patients completed Week 216. DMARD+ (79.7%) and 83.3% of DMARD− patients achieved ACR20 response at week 216; 79.2 and 78.1% achieved 75% improvement from baseline in Psoriasis Area and Severity Index (PASI75). High proportions of DMARD+/DMARD− patients with extra-articular manifestations at baseline reported total resolution at week 216; dactylitis 91.4% of DMARD+ and 93.3% of DMARD− patients, enthesitis 74.4% of DMARD+ and 87.5% of DMARD− patients. Long-term improvements in PsA symptoms were observed with CZP monotherapy or concomitant DMARDs, across important psoriatic disease domains, including joint disease, psoriasis, nail disease, dactylitis, and enthesitis.Trial registration: NCT01087788

Highlights

Psoriatic arthritis (PsA) is a chronic, inflammatory disease, affecting up to a third of psoriasis patients [1]
disease-modifying anti-rheumatic drugs (DMARDs) at baseline consisted of MTX (174 patients, 63.7%), leflunomide (12 patients, 4.4%), sulfasalazine (12 patients, 4.4%), and hydroxychloroquine (1 patient, 0.4%, despite hydroxychloroquine use at baseline being contraindicated in the study protocol)
ACR American College of Rheumatology, American College of Rheumatologists 20% (ACR20)/50/70 American College of Rheumatology 20, 50, and 70% response criteria, BSA body surface area, DMARD disease-modifying anti-rheumatic drug, Health Assessment Questionnaire-Disability Index (HAQ-DI) Health Assessment Questionnaire Disability Index, LDI Leeds Dactylitis Index, LEI Leeds Enthesitis Index, LOCF last observation carried forward, MCID minimal clinically important difference, PASI Psoriasis Area and Severity Index, PASI75/90/100 75, 90, and 100% improvement in PASI a Of patients with ≥ 3% BSA at baseline b Of patients with dactylitis at baseline, defined as ≥ 1 digit affected, with a difference in circumference ≥ 10% c Of patients with LEI > 0 at baseline d Of patients with modified nail psoriasis severity index (mNAPSI) > 0 at baseline e HAQ-DI MCID was defined as a decrease of ≥ 0.35 points from baseline

Summary

Introduction

Psoriatic arthritis (PsA) is a chronic, inflammatory disease, affecting up to a third of psoriasis patients [1]. Clinical features of PsA include progressive and erosive joint inflammation and damage, [1], psoriatic skin disease, and extra-articular manifestations including dactylitis and enthesitis [2]. These symptoms are often accompanied by pain, fatigue, and functional impairment [3], with reductions in patient wellbeing and quality of life [4, 5]. The most recent treatment recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) advise on optimal therapy choices based on disease activity and appropriate subsequent. For patients who did not respond adequately to DMARDs, biological DMARDs (biologics: anti-TNF, anti-IL-12/23, anti-IL-17) are recommended, either with or without concomitant DMARD treatment [6]

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