Is baricitinib beneficial for treating moderate to severe SLE patients? Study findings!

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Baricitinib, a Janus kinase inhibitor is commonly indicated for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. Now, a recent phase 2 study has shown that oral baricitinib 4 mg significantly improved disease activity in SLE patients, especially the rashes and joint manifestations. Professor Morand and his team have published the results in the recent issue of The Lancet.

The multicentre, double-blind, randomized, placebo-controlled study involving 760 participants have shown that a  significantly large number of patients who received baricitinib 4 mg (P=0.016) have attained the SLE Responder Index response with a difference from the placebo. However, adverse events were reported in 10% of patients who received baricitinib 4 mg, 9% who received baricitinib 2 mg, and 7% in the placebo group. The safety profile of baricitinib remained consistent with known findings.

A 2018 study has also reported significant improvement in signs and symptoms with baricitinib 4 mg treatment in patients refractory to standard care of therapy. Treatment for around 24 weeks demonstrated that 70/104 patients who received baricitinib 4 mg ( P=0.0414) and 61/104 who received baricitinib 2 mg (P=0.39) had resolution of arthritis or rash.

The results of both studies determining the safety and efficacy of baricitinib are consistent with the previous investigations. Hence, with the provided information, researchers recommended a phase 3 trial to further corroborate the findings of the oral therapy for SLE.

References

  1. Morand EF, Vital EM, Petri M, Vollenhoven R van, Wallace DJ, Mosca M, et al. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I). The Lancet. 2023 Feb 24;0(0). Available from: https://doi.org/10.1016/S0140-6736(22)02607-1
  2. Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, et al. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. The Lancet. 2018 Jul 21;392(10143):222–31. Available from: https://doi.org/10.1016/S0140-6736(18)31363-1