Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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

I kliniska utvecklingsprogrammet för baricitinib var förekomsten av alopeci angett som en biverkning som drabbade 1,2% av patienterna.

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

 

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. 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.

Datum fӧr senaste ӧversyn 2020 M01 16


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