Olumiant® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant® ▼ (baricitinib): Incidence of Asthma in the RA Clinical Development Program

In the rheumatoid arthritis clinical development program, 56 (EAIR 0.4) patients reported a treatment-emergent adverse event of asthma.

Treatment-Emergent Adverse Events

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

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 Asthma

In this safety analysis, through 24 weeks of treatment, the TEAE of

  • asthma was reported in

    • 4 (0.4%) patients in the BARI 4 mg group

    • 3 (0.6%) patients in the BARI 2 mg group, and

    • 3 (0.2%) patients in the placebo group.1

All BARI RA Analysis Set

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 Asthma

In the All BARI RA analysis set through September 1, 2019, a TEAE of

  • asthma was reported in 56 (1.5%, EAIR=0.4) patients.1

Of these 56 TEAEs of asthma, 

  • 7 were reported as serious adverse events

  • 2 resulted in temporary interruption of BARI, and

  • 0 resulted in permanent discontinuation of BARI.1

Information from the Label

Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.5

The risks and benefits of treatment with baricitinib should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections.5

If an infection develops, the patient should be monitored carefully and baricitinib therapy should be temporarily interrupted if the patient is not responding to standard therapy. Baricitinib treatment should not be resumed until the infection resolves.5

Upper respiratory tract infections was one of the most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2 % of patients treated with baricitinib monotherapy or in combination with conventional synthetic DMARDs.5

Upper respiratory tract infections were very commonly reported with baricitinib in placebo-controlled studies for up to 16 weeks (≥ 1/100 to < 1/10). 

Reporting rates for baricitinib compared to placebo for the infection-related ADRs for up to 16 weeks were:

  • upper respiratory tract infections (14.7 % vs. 11.7 %)5

In treatment-naïve patients, for up to 52 weeks, the frequency of upper respiratory tract infections

  • was greater for the combination treatment of methotrexate and baricitinib (26.0 %) compared to

  • methotrexate alone (22.9 %) or

  • baricitinib alone (22.0 %).5

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Genovese 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

3. Genovese 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

4. Genovese 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.

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

Glossary

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.

Date of Last Review: July 21, 2020


Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 8am - 4pm, excluding Bank Holidays

Or you can

Chat with Us If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a question