“We have to understand that these patients have been treated with methotrexate, steroids and other immunosuppressive medications, so they are prone to develop infections and other complications even without the addition of the biologic agent,” he says. “So it is hard to attribute all the adverse events just to the JAK inhibitor.”
Despite these high rates of adverse events, Dr. Paz says “we have limited treatment options for these patients so I would consider using this medication in patients who failed multiple other interventions and are sick and disabled.”
Saying that gathering safety data across all Phase 3 studies on baricitinib is needed to evaluate when the drug may be contraindicated for which patients, Dr. Genovese emphasizes that the study results provide hope for these difficult to treat patients.
“The message of this study should be one of optimism and hope for both patients and providers that therapies in clinical development can be effective for patients with rheumatoid arthritis and active disease,” Dr. Genovese says.
Mary Beth Nierengarten is a freelance medical journalist based in Minneapolis.
References
- Genovese MC, Kremer J, Zamani O, et al. Baricitnib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016 Mar 31;374(13):1243–1252.
- Eli Lilly and Co., Incyte Corp. Phase 3 study findings demonstrate treatment with baricitinib results in significant improvements for patients with rheumatoid arthritis who had inadequate response to biologics: Pivotal RA-BEACON Study Published in New England Journal of Medicine. PR Newswire. 2016 Mar 31.