Safety and Efficacy of Baricitinib in Patients Receiving Conventional Synthetic Disease-Modifying Antirheumatic Drugs or Corticosteroids

Rheumatol Ther 2018 Dec;5(2):525-536. DOI 10.1007/s40744-018-0128-0

Baricitinib (BARI) in combination with MTX and concomitant csDMARDs was shown to be efficacious, regardless of corticosteroid use in RA patients. MTX is prescribed to most RA patients but concomitant csDMARDs and/or corticosteroids can be added. This study assessed the efficacy and safety of BARI in two arms; with/without corticosteroids and; with MTX only/MTX plus csDMARD/csDMARDs only. Baseline characteristics and adverse reactions were also compared. Data were pooled from two phase 3 studies (RA-BUILD and RA-BEAM), where patients were randomized to PBO or BARI. No significant interactions were seen between BARI 4 mg and PBO in the corticosteroid subgroup. Odds ratios for ACR20 and CDAI ≤10 favoured BARI over PBO at Week 12. Discontinuation rates were higher for corticosteroid users in the BARI group. The rates of adverse events were similar irrespective of MTX and/or csDMARDs use for both PBO and BARI groups. Overall, BARI demonstrated efficacy regardless of concomitant csDMARDs or corticosteroid use, and incidences of adverse events were similar across all patient groups.