Early Initiation of Biologic Improves PsA Disease Outcomes
Golimumab, a tumor necrosis factor inhibitor (TNFi), was associated with rapid and significant improvements in disease outcomes, including remission, among participants with early active psoriatic arthritis (PsA), according to a recent study presented at the American College of Rheumatology annual meeting.
The multicenter, double-blind, randomized controlled trial included participants with active PsA who had not received treatment with methotrexate (MTX) or biologic disease modifying antirheumatic drugs. A total of 26 participants received 50 mg subcutaneous golimumab and MTX and 24 participants received matched placebo and MTX. MTX was started at 15 mg per week and increased to 25 mg per week over 8 weeks.
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The percentage of participants achieving remission on the Disease Activity Score (DAS) at week 22 was assessed as the primary efficacy endpoint. Key secondary endpoints included DAS C-Reactive Protein (CRP), Visual Analogue Scale (VAS) global, VAS pain, VAS physician, swollen joint count (66) (SJC) and tender joint count (68) (TJC), and achievement of minimal disease activity (MDA), as well as safety.
DAS remission was achieved by 81% of participants who received golimumab by week 22 compared with 42% of participants who received MTX only. At week 22, MDA was achieved by 85% of participants who received golimumab compared with 29% of participants who received MTX only. The researchers observed differences in DAS remission and MDA as early as week 8 among 73% and 58% of participants who received golimumab, respectively, compared with 42% and 21% of participants who received MTX only.
In addition, golimumab treatment was associated with significant improvements in several key secondary endpoints compared with MTX, most of which were seen as early as week 8.
Mild to moderate adverse events occurred in 43 out of 50 participants, and the occurrence rates were similar for both treatment arms. One participant in the MTX and placebo group experienced a serious adverse event (cervical spine stenosis), but it was not considered study related and did not result in withdrawal.
“DAS remission at week 22 was achieved by almost double the number of patients with early PsA treated with golimumab + MTX versus placebo + MTX. This double-blind, randomized, placebo-controlled study supports the concept that early initiation of TNFi in patients with active PsA favors rapid and sustained remission.”
van Mens L, de Jong J, Fluri I, et al. Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: A double-blind, randomized, placebo-controlled trial of golimumab + methotrexate versus placebo + methotrexate. Presented at: American College of Rheumatology Annual Meeting; Chicago, IL; October 19-24, 2018. Abstract 1655.