Olumiant® ▼ (baricitinib): Insidens av alopecia i programmet för klinisk utveckling

Incidence of Alopecia

Alopecia is not present in the adverse events listed in the summary of product characteristics.¹

7-Study Placebo-Controlled Dataset

Dataset Description

The 7-study placebo-controlled dataset compared BARI 4 mg vs placebo and included patients with RA who were randomized to BARI 4 mg (N=1142) or placebo (N=1215) from 3 phase 2 and 4 phase 3 studies. In the majority of the studies, patients were on background therapy either with MTX or another csDMARD. The BARI 2-mg data is derived from 4 studies in which both BARI 2 mg (N=479) and BARI 4 mg were options during randomization.^2,3

Evaluation time periods included through 24 weeks of assigned treatment or until rescue in phase 3 studies.^2,3

Incidence of Alopecia

In the 7-study placebo-controlled dataset, through 24 weeks of treatment, alopecia was reported as a TEAE in

• 9 (0.8%) patients who received BARI 4 mg

• 1 patient (0.2%) who received BARI 2 mg, and

• 6 (0.5%) patients who received placebo.²

There was no statistically significant difference between the BARI 4 mg and placebo groups in the incidence of alopecia. The BARI 2 mg arm is included as reference only and no formal statistical comparisons can be made with this group.²

All Baricitinib Rheumatoid Arthritis Dataset

Dataset Description

The All BARI RA safety analysis dataset includes patients with RA (N=3770) from 1 phase 1, 3 phase 2, 5 phase 3 studies, and 1 phase 3 ongoing extension study who received BARI at a variety of doses.^2,3

Incidence of Alopecia

In the All BARI RA analysis, with data through February 13, 2018 and up to 6.9 patient years of exposure, alopecia was reported as a TEAE in 44 (1.2%) patients.²

Incidence of alopecia based on Concomitant Methotrexate Use

6-Study Placebo-Controlled Dataset Description

The 6-study placebo-controlled dataset compared BARI 4 mg vs placebo and included patients with RA who were randomized to BARI 4 mg (N=997) or placebo (N=1070) from 3 phase 2 and 3 phase 3 studies. In the majority of the studies, patients were on background therapy either with MTX or another csDMARD. The BARI 2-mg data is derived from 4 studies in which both BARI 2 mg (N=479) and BARI 4 mg were options during randomization.⁴

Incidence of alopecia

More events of hair loss occurred during the screening process than during the 24-week placebo-controlled period.²

Hair loss is reported as a common side effect of MTX. The majority of cases of alopecia reported during 24 weeks of the BARI placebo-controlled studies occurred

• in the first 12 weeks of treatment, and

• in patients also receiving MTX.^2,5

See Table 1.

Table 1. Distribution of Reports of Alopecia in the Screening Period and First 24 Weeks of 6 Placebo-Controlled Studies of Baricitinib for the Treatment of Rheumatoid Arthritis²

Abbreviations: AE = adverse events; BARI = baricitinib; MTX = methotrexate; PBO = placebo; TEAE = treatment-emergent adverse event.

References

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

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

3. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Ann Rheum Dis. 2019;78(2):308-309. http://dx.doi.org/10.1136/annrheumdis-2019-eular.691

4. Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment. J Rheumatol. 2019;46(1):7-18. http://dx.doi.org/10.3899/jrheum.171361

5. Rheumatrex (methotrexate) [package insert]. Fort Lee, NJ: DAVA Pharmaceuticals, Inc; 2013.

Glossary

AE = adverse event

BARI = baricitinib

csDMARD = conventional synthetic disease-modifying antirheumatic drug

MTX = methotrexate

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.