JAK Inhibitors With or Without Methotrexate in Rheumatoid Arthritis

By Patrick Daly - Last Updated: October 28, 2022

In a meta-analysis published in Frontiers in Immunology, researchers evaluated the safety and efficacy of Janus kinase (JAK) inhibitors with or without methotrexate in patients with active rheumatoid arthritis. According to the study’s authors, JAK inhibitors in combination with methotrexate were superior to JAK inhibitor monotherapy based on American College of Rheumatology (ACR) criteria, disease activity, and remission incidence.

The meta-analysis included three randomized controlled trials encompassing 2290 patients that were published to the Medline, Embase, and Cochrane Library databases. The researchers conducted pooled analysis used random-effects models and identified risk differences (RD) between the two groups. The JAK inhibitors in the enrolled studies included tofacitinib, baricitinib, and filgotinib.

JAK Inhibitor and Methotrexate Superior to JAK Inhibitor Monotherapy

According to the report, patients in the JAK inhibitor plus methotrexate group had a higher proportion of patients who met the ACR criteria compared with the JAK inhibitor monotherapy group at week 52:

  • ACR20: RD, 0.032; 95% CI, -0.027 to 0.091
  • ACR50: RD, 0.050; 95% CI, 0.003-0.097
  • ACR70: RD, 0.056; 95% CI, 0.012-0.100

Additionally, the authors reported that the differences in ACR20, ACR50, and ACR70  between the two groups were also similar at week 24. Furthermore, the groups had no significant differences in the proportion of patients who improved by 0.22 or more on the Health Assessment Questionnaire disability index (HAQ-DI) at weeks 24 and 52.

Comparatively, the authors found that JAK inhibitors plus methotrexate exhibited higher response rates and lower disease activity compared with JAK inhibitor monotherapy at 24 and 52 weeks. Notably, the combination regimen showed a higher risk of treatment-emergent adverse events and adverse events leading to treatment discontinuation.

Overall, the researchers summarized that JAK inhibitor plus methotrexate regimens appeared superior to JAK inhibitor monotherapy based on ACR response, disease activity, and remission. “The two regimens presented comparable physical functioning measured by HAQ-DI improvement and similar tolerability, except for high risks of TEAEs and AEs leading to study discontinuation in combination therapy,” they closed.

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