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 Alopecia in the Rheumatoid Arthritis Clinical Development Program

In the rheumatoid arthritis clinical development program, alopecia was reported as a treatment-emergent adverse event by 1.2% of patients who received baricitinib.

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 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, 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 01 September 2019.4,5

Incidence of Alopecia

In the All BARI RA analysis up to 8.4 PYE, alopecia was reported as a TEAE in 48 (1.3%; EAIR=0.4) patients.2

None of these TEAEs were considered serious, or led to temporary interruption or permanent discontinuation of BARI.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.6

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.2,7

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

 

PBO (N=1070)

BARI 2 mg (N=479)

BARI 4 mg (N=997)

Total BARI (2 mg and 4 mg)

Total Cases

Overall (Screening Period and TEAEs)

MTX Yes, n

12

2

9

11

23

MTX No, n

3

1

4

5

8

Total, n

15

3

13

16

31

Non-Treatment Emergent AEs During Screening Period

MTX Yes, n

9

1

4

5

14

MTX No, n

1

1

0

1

2

Total, n

10

2

4

6

16

TEAEs in First 24 Weeks

MTX Yes, n

3

1

6

7

10

MTX No, n

2

0

3

3

5

Total, n

5

1

9

10

15

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. 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. http://scientific.sparx-ip.net/archiveeular/?c=a&view=4&item=2020FRI0123

5. 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.

6. 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

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

Glossary

BARI = baricitinib

csDMARD = conventional synthetic disease-modifying antirheumatic drug

MTX = methotrexate

PYE = patient-years of exposure

RA = rheumatoid arthritis

TEAE = treatment-emergent adverse event

Appendix

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: June 01, 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

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

Submit a question