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Baricitinib: Incidence of Headache in the Rheumatoid Arthritis Clinical Development Program
Headache is reported as a common (≥1% and <10%) adverse drug reaction with baricitinib treatment.
Baricitinib Prescribing Information
Based on data from clinical studies of BARI, headache was reported as a common (≥1% and <10%) adverse drug reaction.1
Treatment-Emergent Adverse Event
A TEAE is an adverse event that either occurred or worsened in severity after the first dose of study treatment and did not necessarily have a causal relationship to study treatment.1
Incidence of Headache in the Baricitinib Rheumatoid Arthritis Clinical Development Program
7-Study Placebo-Controlled Dataset
The 7-study pooled dataset included patients with RA randomized to BARI 4 mg (N=1142, PYE=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Patients could have been taking background MTX or other conventional DMARDs. Evaluation time periods included through
the 12-week placebo-controlled period in phase 2 studies
16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and
24 weeks of assigned treatment or until rescue in phase 3 studies.2
Data from BARI 2 mg (N=479, PYE=185.8) were derived from 4 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).2
Incidence of Headache
In this safety analysis, through 24 weeks of treatment, the TEAE of headache was reported in
The All BARI RA analysis set included 3770 patients with RA who received BARI at a variety of doses from 1 phase 1, 3 phase 2, and 5 phase 3 studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with
Postmarketing Spontaneous Reports of Headache With Baricitinib Treatment
In post-marketing spontaneous adverse event reporting as of June 22, 2020, the TEAE of headache was uncommonly reported (≥0.1% and <1%).1
Postmarketing data do not necessarily represent the rate of occurrence of an AE in a treated population, but they represent a reporting rate of a particular AE to the company. Spontaneous reporting of AEs can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an event.5
Spontaneous reporting has limited use due to
lack of control population
under-reporting or reporting bias, and
missing or incomplete information regarding medical history or concomitant medications.5
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis over a median of 3 years of treatment: an updated integrated safety analysis. Lancet Rheumatol. 2020;2(6):E347-E357. https://doi.org/10.1016/S2665-9913(20)30032-1
3Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis [abstract]. Ann Rheum Dis. 2020;79(suppl 1):638. https://ard.bmj.com/content/79/Suppl_1/642.1
4Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. Poster presented at: European League Against Rheumatism Virtual Congress; June 3-6, 2020.