Management of rheumatoid arthritis (RA) includes control of synovitis, improvement of physical function and prevention of joint damage and disability. Conventional and biological disease-modifying antirheumatic drugs (bDMARD) may have disadvantages such as low disease remission activity, lose response over time, safety or tolerability issues, including infections in some patients.

Baracitinib is an oral selective Janus kinase (JAK1/JAK2) inhibitor used as an alternative option in the management of moderate to severely active rheumatoid arthritis. A comparative evaluation of trials with the more extended time frame is required to evaluate the drug safety profile 

Smolen JS et al. conducted a clinical trial to analyze the safety profile of baracitinib by collecting data from available RA clinical trials, including a long-term extension (LTE) study. The study included all-bari-RA group and a placebo group. The dose assessment was based on four studies with 2 mg and 4 mg including LTE data ("2 mg-4 mg-extended"). A total of 3492 patients received baricitinib for 6637 total patient-years (PY) of exposure (max 5.5 yrs). 

The results of the study indicated no differences in death rates, malignancies, serious infections, adverse events leading to drug discontinuation, and major adverse cardiovascular event (MACE), for 4 mg v/s placebo or 4 mg versus 2 mg. Infections including herpes zoster were more frequent in 4 mg versus placebo, and deep vein thrombosis or pulmonary embolism was reported in 4 mg and not in placebo group. About 6 cases of lymphoma, three gastrointestinal perforations,10 cases of tuberculosis, and 22 all-cause deaths were reported in an all-bari-RA group. Incidence rates for malignancies (0.8/100 PY) and MACE (0.5/100 PY) were low and did not increase with prolonged exposure. The baracitinib showed an acceptable safety profile and efficacy in patients with moderate to severely active RA with an average exposure of approx 5.5 years.