Long-term effectiveness and safety of infliximab, golimumab and ustekinumab in patients with psoriatic arthritis from a Canadian prospective observational registry

Abstract

Objectives: The objectives of this study were to describe the demographic profile and baseline disease characteristics of patients with psoriatic arthritis (PsA) treated with either infliximab (IFX), subcutaneous golimumab (GLM) or ustekinumab (UST) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety.

Methods: Patients with PsA were enrolled into the Biologic Treatment Registry Across Canada registry (ClinicalTrials.gov Identifier: NCT00741793) from 2005 to 2017. The study visits occurred at study enrolment (baseline) and every 6 months thereafter. Effectiveness was assessed by changes in disease parameters (joint counts, Psoriasis Area Severity Index (PASI), Health Assessment Questionnaire, patient/physician global, minimal disease activity, enthesitis, dactylitis, erythrocyte sedimentation rate, C reactive protein). Improvements from baseline were explored with the paired t-test and the McNemar's test. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates.

Results: A total of 111 IFX-treated, 281 GLM-treated and 70 UST-treated patients were enrolled. Most baseline disease parameters remained similar over time in all three cohorts. UST-treated patients had lower mean baseline Disease Activity Score in 28 joints CRP, swollen joint based on 28 joints and higher PASI compared with patients treated with GLM. Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters over time (p<0.001) from baseline up to 84, 84 and 40 months, respectively.AEs were reported for 74.8%, 69.8% and 52.9% (138, 114 and 115 events/100 patient-years (PYs)) covering 325, 567 and 87 years of exposure for IFX-treated, GLM-treated and UST-treated patients, respectively. Severe AEs were reported in 19.8%, 8.5% and 5.7% (8.8, 7.2 and 8.0 events/100 PYs) in IFX-treated, GLM-treated and UST-treated patients, respectively. The proportion of patients who discontinued treatment were 63.1%, 50.9% and 50.0%, respectively.

Conclusions: IFX, GLM and UST treatment significantly reduced disease activity and improved functionality in patients with PsA followed by routine clinical practice and had a safety profile similar to that previously reported in the literature.

Trial registration number: NCT00741793.

Keywords: clinical trials; immunology; rheumatology.

Conflict of interest statement

Competing interests: PR has received consulting fees for Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer and Roche; and received research grant from Janssen. RA, DS and MS received grant/research support from Janssen. MK received grant/research support from Novartis and consultant fees from Amgen, Celgene, Gebro, Janssen, Novartis, Pfizer, Lilly and Merck. AJL and FN are employees of Janssen Inc. and are JNJ stockholders.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Evolution of baseline characteristics over time. CRP, C reactive protein; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; GLM, golimumab; HAQ, Health Assessment Questionnaire; IFX, infliximab; PASI, Psoriasis Area Severity Index; SJC, swollen joint count; TJC; tender joint count; UST, ustekinumab.

Figure 2

Effect of treatment with IFX, GLM and UST on disease parameters over time. Observed data. P value versus baseline. GLM, golimumab; HAQ, Health Assessment Questionnaire; IFX, infliximab; PASI, Psoriasis Area Severity Index; PtGA, patient global assessment; SJC, swollen joint count; TJC; tender joint count; UST, ustekinumab.