Table 5.

Baricitinib in rheumatoid arthritis (RA)

Study name	No.of subjects	Participants	Intervention	Study duration	Efficacy	Adverse events	Serious adverse events
Genovese et al. [132] (RA-BEACON)	527	Active RA with inadequate response/unacceptable side effects with ≥TNF inhibitors, other biologics DMARDs, or both	Randomly assigned in 1:1:1 baricitinib 2 or 4 mg daily or placebo for 24 weeks	24 weeks	Baricitinib 4, 2 mg and placebo had ACR20 response at 12 weeks 55, 49 and 27% (p < 0.001). Significant difference in HAQ-DI and DAS28-CRP between higher-dose baricitinib group and placebo group	Mild neutropenia, increased serum creatinine, LDL, herpes zoster	Fatal stroke, MI, non melanomatous skin cancers
Dougados et al. [133] (RA-BUILD)	684	Active RA and inadequate response to conventional DMARDs	Randomized 1:1:1 to placebo or baricitinib (2 or 4 mg) daily with stable background treatment	24 weeks	ACR20 response at week 12 was 62% with baricitinib 4 mg, 66% in 2 mg, and 40% with placebo (p ≤ 0.001). Improvements in ACR50, ACR70, DAS28, CDAI, SDAI, and HAQ-DI	Similar in all groups, no opportunistic infection, no GI perforation	Tuberculosis: 1 case, Non-melanomatous skin cancer: 1 case in baricitinib 4 mg
Fleischmann et al. [131] (RA-BEGIN)	584	Active RA, no previous DMARD other than ≤3 doses of MTX	Randomized 4:3:4 to MTX, baricitinib 4 mg once daily (baricitinib monotherapy), or baricitinib 4 mg QD + MTX for up to 52 weeks	Results reported at 24 weeks	ACR20 response higher with baricitinib 4 mg monotherapy vs. MTX (77% vs. 62%, p ≤ 0.01). Compared with MTX, baricitinib 4 mg monotherapy produced significantly greater improvements in ACR 50, 70, CDAI, SDAI, DAS28-CRP, HAQ-DI, MTX and baricitinib 4 mg combination was not superior to baricitinib monotherapy	Similar in all groups Herpes zoster, anemia, leukopenia, transaminitis	PJP, esophageal candidiasis in combination group
Taylor et al. [134] (RA-BEAM)	1305	Active RA on stable background MTX	Randomized 3:3:2 to placebo, baricitinib 4 mg once daily, or adalimumab 40 mg biweekly	24 weeks, results reported at 12 and 24 weeks	ACR20 higher for baricitinib vs. placebo (70 vs. 40%, p ≤ 0.001). ACR20 with adalimumab 61%. Significant improvements in ACR 20/50/70 and HAQ-DI, DAS28, CDAI, and SDAI for baricitinib vs. placebo. Compared with ADA, baricitinib superior in ACR20 and DAS28-CRP. Diminished radiographic progression with Bari vs. placebo	Anemia, leukopenia, transaminitis, 3 opportunistic infections	1 case of pneumonia and 1 duodenal ulcer hemorrhage 5 malignancies, 1 case of TB

ACR20/50/70 American College of Rheumatology 20, 50 and 70% improvement criteria, ARDS acute respiratory distress syndrome, ARF acute renal failure, AV atrioventricular, Ca carcinoma, CCF congestive cardiac failure, CCP cyclic citrullinated peptide, CMV cytomegalovirus, COPD chronic obstructive pulmonary disease, Cr serum creatinine, CRP C-reactive protein, DAS28 Disease Activity Score 28, DMARD disease-modifying anti-rheumatic drugs, DVT deep vein thrombosis, ESR erythrocyte sedimentation rate, GI gastrointestinal, HAQ-DI Health Assessment Questionnaire-Disability Index, HDL high-density lipoprotein, LDL low-density lipoprotein, MI myocardial infarction, MTX methotrexate, NNT number needed to treat, NSAIDs non-steroidal anti-inflammatory drugs, PE pulmonary embolism, PJP pneumocystis jirovecii pneumonia, PNA pneumonia, PRO patient-reported outcome, PtGA patient global assessment, RF rheumatoid factor, RTI respiratory tract infections, SF-36 36-Item Short Form Health Survey, TB tuberculosis, TNF tumor necrosis factor, URI upper respiratory tract infections, UTI urinary tract infections