Olumiant® ▼ (baricitinib): Förekomst av ögonsjukdomar i RA kliniska utvecklingsprogram

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 Eye Disorders

Through 24 weeks of treatment, TEAE categorized as eye disorders were reported in

• 35 (3.1%) patients in the BARI 4 mg group

• 13 (2.7%) patients in the BARI 2 mg group, and

• 35 (2.9%) patients in the placebo group.¹

The most commonly reported eye disorders in any treatment group are presented in Table 1.

Table 1. 7-Study Pooled Dataset: Incidence of Eye Disorders Occurring in ≥0.2% of Patients in Any Treatment Group Through 24-Weeks of Treatment¹

Abbreviations: BARI = baricitinib; PBO = placebo.

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 Eye Disorders

In the All BARI RA analysis set through September 1, 2019, TEAEs categorized as eye disorders were reported in 361 (9.6%, EAIR=2.7) patients.¹

Of these 361 eye disorder related TEAEs

• 21 were reported as serious adverse events

• 12 resulted in temporary interruption of BARI, and

• 0 resulted in permanent discontinuation of BARI.¹

The incidence of most common eye disorders reported in the All BARI RA analysis set through September 1, 2019 can be seen in Table 2.

Table 2. All BARI RA Dataset: Incidence of Eye Disorders Occurring in ≥0.2% of Patients¹

Abbreviations: EAIR = exposure-adjusted incidence rate; SAE = serious adverse event; TEAE = treatment emergent adverse event; TI = temporary interruption.

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.

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.