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 Acne in the Rheumatoid Arthritis Clinical Development Program

Acne is a known adverse drug reaction with baricitinib. In baricitinib clinical trials for RA and AD, acne was commonly reported (≥ 1% and < 10%).

Incidence of Acne in the RA Baricitinib Clinical Development Program

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 Acne

In this safety analysis, through 24 weeks of treatment, the TEAE of acne was reported in

  • 8 (0.7%) patients in the BARI 4 mg group,

  • 2 (0.4%) patients in the BARI 2 mg group, and

  • 0 patients in the placebo group.1

No incidences of dermatitis acneiform were reported.1

All Baricitinib Rheumatoid Arthritis 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 Acne

In the All BARI RA analysis dataset through September 1, 2019, a TEAE of acne was reported in 48 (1.3%) of patients.1

Table 1. Incidence of Acne in the All BARI RA Analysis Dataset1

TEAE

n (%)

EAIR

Acne

43 (1.1)

0.3

Dermatitis acneiform

5 (0.1)

0.0

Acne cystic

2 (0.1)

0.0

Acne cosmetics

1 (0.0)

0.0

Abbreviations: EAIR = exposure-adjusted incidence rate; TEAE = treatment-emergent adverse event.

Of these 48 TEAEs of acne

  • 0 were reported as serious adverse events

  • 1 resulted in temporary interruption of BARI (dermatitis acneiform), and

  • 1 resulted in permanent discontinuation of BARI (dermatitis acneiform).1

Information From the Label

Acne is a known adverse drug reaction with BARI.1

Based on the pooled rheumatoid arthritis and atopic dermatitis clinical trials acne was reported as a common adverse event (≥ 1/100 to < 1/10). In patients treated with baricitinib in the rheumatoid arthritis clinical trials, the frequency was uncommon (≥ 1/1,000 to < 1/100). 5

For BARI RA trials, the term acne included acne and dermatitis acneiform. For BARI AD trials, the term acne included the cluster of terms

  • acne

  • dermatitis acneiform, and

  • acne varioliformis.1

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

AD = atopic dermatitis

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: September 01, 2020


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