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THU0213 Comparative efficacy and safety of baricitinib 2 MG and 4 MG in patients with active rheumatoid arthritis: a bayesian network meta-analysis of randomized controlled trials
  1. YH Lee,
  2. YH Seo,
  3. GG Song
  1. Rheumatology, Korea University Medicial Center, Seoul, Korea, Republic Of

Abstract

Background Baricitinib is a potent, selective JAK1 and JAK2 inhibitor. Baricitinib has been investigated in phase II and phase III studies of active patients with rheumatoid arthritis (RA). who showed an inadequate response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate (MTX) and biologics. However, due to the lack of adequate multiple comparisons, the comparative efficacy and safety of baricitinib in various treatment regimens with different dosages or in combination with DMARDs or MTX remains unclear.

Objectives This study aimed to assess the relative efficacy and safety of once-daily baricitinib 2 mg and 4 mg administration in patients with active RA.

Methods We performed a literature search using MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and the EULAR and ACR conference proceedings. In this network meta-analysis, randomized controlled trials (RCTs) examining the efficacy and safety of baricitinib in patients with active RA were included. A Bayesian network meta-analysis was conducted to combine the direct and indirect evidence from the RCTs.

Results Seven RCTs involving 3,461 patients met the inclusion criteria. There were 10 pairwise comparisons, including 7 direct comparisons and 5 interventions. The ACR20 response rate was significantly higher in the baricitinib 4 mg in combination with disease-modifying antirheumatic drugs (DMARD) group than in the placebo+DMARD group (OR 3.13, 95% CrI 2.32–4.33). Compared with the placebo+DMARD group, the baricitinib 4 mg, baricitinib 2 mg+DMARD, and adalimumab 40 mg+MTX groups showed a significantly higher ACR20 response rate. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that baricitinib 4 mg+DMARD was likely to elicit the best ACR20 response rate (SUCRA =0.7930), followed by baricitinib 4 mg (SUCRA =0.7034), baricitinib 2 mg+DMARD (SUCRA =0.6304), adalimumab 40 mg+MTX (SUCRA =0.3687), and placebo+DMARD (SUCRA =0.0045). By contrast, the safety based on the number of treatment-emergent adverse events (TEAEs) did not differ significantly among the 5 interventions.

Conclusions Baricitinib 2 mg and 4 mg administered once daily was an efficacious intervention for active RA that had no significant risk of TEAE development.

Acknowledgements None

Disclosure of Interest None declared

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