Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Insidens av alopecia vid reamatoid artrit

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

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en-GB

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 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 Arthritis.

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

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

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

3Genovese 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

4Genovese 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

5Genovese 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.

6Smolen 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

7Rheumatrex (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

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 June 01, 2020


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