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The analysis found out that the selective
Janus kinase (JAK1/JAK2) inhibitor, baricitinib exhibits a favourable long-term
safety profile among active rheumatoid arthritis patients.
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.
The Journal of Rheumatology
Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment.
Smolen JS et al.
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