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Baricitinib for relapsing giant cell arteritis: a prospective open-label 52-week pilot study
  1. Matthew J Koster1,
  2. Cynthia S Crowson2,
  3. Rachel E Giblon2,
  4. Jane M Jaquith1,
  5. Ali Duarte-García1,
  6. Eric L Matteson1,
  7. Cornelia M Weyand1,
  8. Kenneth J Warrington1
  1. 1 Department of Internal Medicine, Division of Rheumatology, Mayo Clinic, Rochester, Minnesota, USA
  2. 2 Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota, USA
  1. Correspondence to Dr Matthew J Koster, Department of Internal Medicine, Division of Rheumatology, Mayo Clinic, Rochester, USA; koster.matthew{at}


Background/purpose Preclinical vascular inflammation models have demonstrated effective suppression of arterial wall lesional T cells through inhibition of Janus kinase 3 and JAK1. However, JAK inhibition in patients with giant cell arteritis (GCA) has not been prospectively investigated.

Methods We performed a prospective, open-label, pilot study of baricitinib (4 mg/day) with a tiered glucocorticoid (GC) entry and accelerated taper in patients with relapsing GCA.

Results 15 patients were enrolled (11, 73% female) with a mean age at entry of 72.4 (SD 7.2) years, median duration of GCA of 9 (IQR 7–21) months and median of 1 (1–2) prior relapse. Four (27%) patients entered the study on prednisone 30 mg/day, 6 (40%) at 20 mg/day and 5 (33%) at 10 mg/day. Fourteen patients completed 52 weeks of baricitinib. At week 52, 14/15 (93%) patients had ≥1 adverse event (AE) with the most frequent events, including infection not requiring antibiotics (n=8), infection requiring antibiotics (n=5), nausea (n=6), leg swelling (n=2), fatigue (n=2) and diarrhoea (n=1). One subject required baricitinib discontinuation due to AE. One serious adverse event was recorded. Only 1 of 14 (7%) patients relapsed during the study. The remaining 13 patients achieved steroid discontinuation and remained in disease remission during the 52-week study duration.

Conclusion In this proof-of-concept study, baricitinib at 4 mg/day was well tolerated and discontinuation of GC was allowed in most patients with relapsing GCA. Larger randomised clinical trials are needed to determine the utility of JAK inhibition in GCA.

Trial registration number NCT03026504.

  • giant cell arteritis
  • systemic vasculitis
  • therapeutics

Data availability statement

All data relevant to the study are included in the article.

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Data availability statement

All data relevant to the study are included in the article.

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  • Handling editor Josef S Smolen

  • Contributors All authors were involved in drafting the article or revising it critically for important intellectual content, and approved the final version to be submitted for publication. MJK and KJW had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Guarantor of study: MJK. Study conception and design: MJK and KJW; acquisition of data: MJK, KJW and JMJ; analysis and interpretation of data: REG, CSC, MJK, KJW, ELM, AD-G and CMW.

  • Funding Eli Lilly and Company provided funding to support the completion of this investigator-initiated study.

  • Competing interests KJW (principal investigator) and JMJ (study coordinator) received support through funds paid to Mayo Clinic, from Eli Lilly, to assist in the completion of this study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.