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Is there any long-term safety data available for baricitinib?

Featuring Michael Cameron, MD |

Assistant Professor
Mount Sinai Ichan School of Medicine
New York, NY

| Published August 01, 2023


Dr. Michael Cameron discusses the long-term safety data available for baricitinib, a drug used in the treatment of rheumatoid arthritis and alopecia areata. The drug has been in use for many years for rheumatoid arthritis, and now several years of data are available for its use in alopecia areata. Comparing the safety data with that of another drug, tofacitinib, used in rheumatoid arthritis, there are no significant safety signals seen for baricitinib. 

The safety signals observed with tofacitinib in a study for rheumatoid arthritis included issues like malignancy, clustering of organ systems for malignancy (lymphoma or lung cancers), cardiac events, blood clots, and an increased risk of serious infections, including shingles. However, in the case of baricitinib used for alopecia areata, there are no such signals. The safety profile for baricitinib in alopecia areata is described as "really, really clean" by Dr. Cameron. 

Overall, the data indicates that baricitinib appears to be safe for long-term use in treating alopecia areata, with no significant safety concerns observed in the studied period. 

Key Points 
  • Baricitinib has been used for many years in rheumatoid arthritis. 
  • There is now data available for baricitinib use in alopecia areata. 
  • The safety signals observed with tofacitinib use in rheumatoid arthritis are not seen with baricitinib in alopecia areata. 
  • No signal for malignancy or clustering of organ systems for malignancy (e.g., lymphoma or lung cancers) is observed. 
  • There are no significant cardiac events or blood clot risks associated with baricitinib use. 
  • There is no increased risk for serious infections, including shingles, with baricitinib use. 
  • The rate of adverse events with baricitinib is almost numerically equivalent to placebo, with only a slight increase observed. 
  • Baricitinib shows a very clean safety profile in alopecia areata.

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