In patients with psoriatic arthritis (PsA), early treatment initiation with golimumab plus methotrexate (MTX) was associated with a nearly 2-fold improvement in remission compared with the use of MTX alone, according to study results published in Annals of the Rheumatic Diseases.
The multicenter, investigator-initiated, double-blind, randomized, placebo-controlled study (ClinicalTrials.gov identifier: NCT01871649) was conducted at 3 centers in The Netherlands between September 2013 and September 2017. The investigators sought to explore whether combination therapy with golimumab plus MTX as a first-line treatment in patients with PsA was superior to MTX alone at inducing disease remission. A total of 51 MTX- and biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients with PsA, according to Classification Criteria for Psoriatic Arthritis (CASPAR), who had active disease at baseline (≥3 swollen joint count/tender joint count) were enrolled in the study. All participants were age 18 to 70 years.
All participants were randomly assigned to receive 5 injections of golimumab 50 mg or placebo administered subcutaneously each month. In both treatment groups, oral MTX was initiated at a dose of 15 mg per week and increased to 25 mg per week over 8 weeks. The primary study end point was the percentage of patients who attained Disease Activity Score (DAS) remission (<1.6) at 22 weeks. Safety was evaluated throughout the duration of the study. Overall, 26 patients were randomly assigned to golimumab 50 mg monthly plus MTX (tumor necrosis factor inhibitor [TNFi] group) and 25 patients were randomly assigned to matched placebo plus MTX (MTX group).
Results of the study demonstrated that the primary efficacy end point was achieved by 81% of patients in the TNFi group and 42% of patients in the MTX group (P =.004). The difference in DAS remission was observed as early as 8 weeks following study initiation. A significant difference in favor of the TNFi group was also reported with respect to such other response criteria as Minimal Disease Activity (P <.001) and 20%, 50%, and 70% improvements in American College of Rheumatology criteria (P =.039, P =.001, and P =.001, respectively).
Regarding safety findings, the rates of adverse events and treatment-emergent adverse events were similar in both treatment groups.
The investigators concluded that early intervention with TNFi therapy in patients with PsA, rather than the use of the classical step-up approach, is linked to the attainment of disease remission. Additional studies are warranted to confirm whether the responses reported in this study can be maintained up to 50 weeks on MTX monotherapy.
van Mens LJJ, de Jong HM, Fluri I, et al. Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate. Ann Rheum Dis. 2019;78(5):610-616.