Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Incidens av huvudvärk i de kliniska prövningarna för reumatoid artrit

Huvudvärk rapporteras som en vanlig (≥1% och <10%) biverkning vid behandling med baricitinib.

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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

Information From the Label 

Based on data from clinical studies of BARI, headache was reported as a common (≥1% and <10%) adverse drug reaction. This frequency is based on integrated data across both rheumatoid arthritis and atopic dermatitis indications.6

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

6Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M08 28


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