Olumiant® (Baricitinib)

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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.

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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

Dataset Description

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

  • 46 (4.0%) patients in the BARI 4 mg group,
  • 33 (6.9%) patients in the BARI 2 mg group, and
  • 44 (3.6%) patients in the placebo group.1

All BARI RA Dataset

Dataset Description

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

  • 13,148 PYE
  • median exposure of 4.2 years
  • maximum exposure of 8.4 years, and
  • data through September 1, 2019.3,4

Incidence of Headache

In the All BARI RA analysis dataset through September 1, 2019, a TEAE of headache was reported in 248 (6.6%, EAIR=1.9) patients.1

Of these 248 TEAEs of headache

  • 4 were reported as serious adverse events
  • 3 resulted in temporary interruption of BARI, and
  • 0 resulted in permanent discontinuation of BARI.1

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

References

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.

5Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(suppl 3):C40-C44. http://dx.doi.org/10.1016/S0149-2918(98)80007-6

Glossary

AE = adverse event

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

EAIR = exposure-adjusted incidence rate

MTX = methotrexate

PYE = patient-years of exposure

RA = rheumatoid arthritis

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2020 M08 28


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