Methotrexate, Apremilast Show Similar Efficiency Outcomes in Head-to-Head PsA Study


Both drugs were well tolerated and without any serious adverse events.

In patients with psoriatic arthritis (PsA),methotrexate and apremilast (Otezla, Amgen) were equally effective in controlling disease activity and were well tolerated, according to a small head-to-head study published in Rheumatology International.1

Methotrexate, Apremilast Show Similar Efficiency Outcomes in Head-to-Head PsA Study

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“There was no difference in the efficacy of both the drugs as measured by major clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), American College of Rheumatology ≥20% improvement (ACR20) response, and Psoriasis Area and Severity Index (PASI),” wrote Joydeep Samanta, MD, of the Post Graduate Institute of Medical Education and Research in Chandigarh, India, and colleagues. “Both the drugs were well tolerated and had similar adverse event profiles.”

The APREMEPsA study, a single blind, randomized controlled trial, was conducted to compare the efficacy of methotrexate and apremilast in patients with active PsA. Between October 2019 and December 2020, a total of 31 patients were recruited from a tertiary hospital in India. The patients had not taken methotrexate/apremilast in the prior 3 months and had never received biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKs). The methotrexate group (n=16, median age:39, male:9) was started on 15 mg weekly with 5 mg dose increments every 4 weeks depending on disease activity with the maximum target dose of 25 mg per week. The apremilast group (n=15, median age:38, male:8) was started on 10 mg once per day, which was increased by 10 mg daily to a target dose of 30 mg twice daily. A total of 26 patients, 13 in each treatment group, completed 24 weeks follow-up.

The primary outcome measure was the rate of major cDAPSA response at week 24. The secondary outcome measures were ACR20 response, change in PASI score, Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), Leeds Dactylitis Index (LDI), and Health Assessment Questionnaire-Disability Index (HAQ-DI), along with the number of adverse events at week 24 between methotrexate and apremilast groups.

At baseline, the median cDAPSA score was 23 in the apremilast group and 20 in the methotrexate group. At week 24, no difference in major cDAPSA response was observed between the apremilast and methotrexate group (20% vs. 37.5%; P = .433).

While only the methotrexate group saw improvement in LDI and HAQ-DI, there was no significant difference between the methotrexate and apremilast groups in terms of all secondary outcome measures. A total of 9 adverse events occurred in 7 patients, but they were all mild and there was no difference in the adverse event rate between the groups.

“Considering the small sample size in our study, a larger study is needed to confirm these findings,” the investigators concluded.


  1. Samanta J, Naidu G, Chattopadhyay A, et al. Comparison between methotrexate and apremilast in Psoriatic Arthritis-a single blind randomized controlled trial (APREMEPsA study) [published online ahead of print, 2023 Mar 24]. Rheumatol Int. 2023;1-8. doi:10.1007/s00296-023-05315-4
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