Session Information
Date: Monday, October 22, 2018
Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Clinical/Epidemiology Studies
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: In inflammatory arthritis such as RA, early initiation of highly effective targeted treatments is a successful strategy to aim for sustained remission.1 Here we aimed to assess if a similar strategy is effective in psoriatic arthritis(PsA) by assessing the efficacy and safety of golimumab + methotrexate (MTX) vs. MTX alone in PsA patients with early, active disease.
Methods: This investigator-initiated, multicenter, double blind, randomized, placebo-controlled trial included MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 SJC/TJC). Patients were randomized to either golimumab (50mg SC monthly) + MTX (n=26) (TNFi arm) or matched placebo + MTX (n=24) (MTX arm). MTX was started 15 mg/week orally and increased to 25mg/week over 8 weeks. Primary efficacy endpoint was % of patients achieving DAS remission (<1.6) at week 22. Key secondary endpoints included changes in DAS CRP, VAS global, VAS pain, VAS physician, SJC (66) and TJC (68) and achievement of MDA. Safety was assessed throughout the study.
Results: The baseline demographics and disease characteristics were similar between both groups. The median disease duration at inclusion was 0.5 (0.5-2) (yrs), disease activity at baseline was: DAS CRP 2.25 (1.86-2.78) swollen joint count (66) 5(4-8.25); tender joint count (68) 10(5-15.3), PASI 1.75(0.35-4.48). The median MTX dosage used was 19.2(4.5) mg/week in the TNFi arm and 21.2(2.4) in the MTX arm. There were 6 early drop-outs due to withdrawal of informed consent: 1 in the TNFi arm (wk14), 1 in the MTX arm (wk14); due to AE: 1 in the TNFi treatment arm (wk14) and 3 in the MTX arm (wk14).
The study met the primary efficacy endpoint with DAS remission at week 22 achieved by 81% of the subjects in the TNFi arm versus 42% in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8 (73% vs. 42%, p=0.025). MDA was achieved by 81% vs. 29% at week 22 (p<0.001) and in 58% vs. 21% at week 8 (p=0.008). A significant difference in favor of the TNFi arm at week 22 was also observed for several key secondary endpoints, most secondary parameters were already significantly different in favor of the TNFi arm at week 8 (Figure 1).
As to safety, one SAE occurred in a patient in the MTX arm (cervical spine stenosis), which was considered not to be study related and did not result in early withdrawal. 43/50 patients experienced ≥1 AE (range 1-7), all of which were graded mild to moderate. The occurrence rates of AE and TEAE were similar in both arms.
Conclusion: 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.
1 Bijlsma et al, U-ACT-EARLY study, Lancet, 2016
To cite this abstract in AMA style:
van Mens L, de Jong J, Fluri I, van de Sande M, Nurmohamed M, Kok MR, van Kuijk A, Baeten D. Achieving Remission in Psoriatic Arthritis By Early Initiation of TNF Inhibition: A Double-Blind, Randomized, Placebo-Controlled Trial of Golimumab + Methotrexate Versus Placebo + Methotrexate [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/achieving-remission-in-psoriatic-arthritis-by-early-initiation-of-tnf-inhibition-a-double-blind-randomized-placebo-controlled-trial-of-golimumab-methotrexate-versus-placebo-methotrexate/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/achieving-remission-in-psoriatic-arthritis-by-early-initiation-of-tnf-inhibition-a-double-blind-randomized-placebo-controlled-trial-of-golimumab-methotrexate-versus-placebo-methotrexate/