Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Viktökning

Viktökning med baricitinibbehandling har rapporterats i ovanliga fall i kliniska studier av reumatoid artrit.

Summary

The proportion of patients with reported TEAE of weight gain through 16 weeks was: 

  • in a 6 study safety analysis dataset compared BARI 4 mg vs placebo:  

    • 0.6% in the BARI 4 mg group, and 

    • 0.5% in the placebo group.1

  • In a 4 study safety analysis dataset comparing BARI 2 mg vs BARI 4 mg vs placebo

    • 0.8% in the BARI 4 mg group

    • 0.8% in the BARI 2 mg group, and

    • 0.4% in the placebo group.1

Incidence of Weight Gain in the Rheumatoid Arthritis Clinical Trials

The description of the study datasets are available Safety Dataset Descriptions.

Baricitinib vs Placebo 6-Study Dataset

The proportion of patients with reported TEAE of weight gain through 16 weeks was

  • 0.6% in the BARI 4 mg group, and 

  • 0.5% in the placebo group.1

Baricitinib 2 mg vs 4 mg vs Placebo 4-Study Dataset

The proportion of patients with reported TEAE of weight gain through 16 weeks was

  • 0.8% in the BARI 4 mg group

  • 0.8% in the BARI 2 mg group, and

  • 0.4% in the placebo group.1

Abnormal Weight Gain by Body Weight Strata

Abnormal weight gain was defined as an increase of ≥7% from the highest value recorded during baseline. The proportion of patients with abnormal weight gain was analyzed with baseline weight stratified into

  • 3 strata, divided by

    • <60 kg

    • 60 to <100 kg, and

    • 100 kg, and

  • 2 strata, divided by

    • median weight, and

    • >median weight.1

Baricitinib vs Placebo 6-Study Dataset

The proportion of patients who had a ≥7% weight gain was numerically greater with BARI 4 mg compared to placebo for patients in all size strata.1 Details presented in Table 1

The proportion of patients with an abnormal weight gain was the largest, and the difference between BARI 4 mg and placebo was only statistically significant for the strata with

  • body weight <60 kg (OR=5.0 and CI [2.3, 11.0]),

  • below median weight, defined as ≤71 kg (OR=5.0 and CI [2.6, 9.6]), and

  • BMI <25 kg/m2 (OR=5.0 and CI [2.5, 10.0]).1

In the BARI 4-mg group, the proportion of patients with an abnormal weight gain decreased as the baseline weight or BMI increased.1

There were no reports of peripheral edema or congestive heart failure by patients with abnormal weight gain in either the BARI 4-mg or placebo group through week 24.1

Baricitinib 2 mg vs 4 mg vs Placebo 4-Study Dataset

There was no significant difference in the proportion of patients who had a ≥7% weight gain in all baseline weight strata between the BARI 2-mg group and the

  • placebo group, and

  • BARI 4-mg group.1

For the proportion of patients with abnormal weight gain by strata see Table 1

Table 1. Weight Gain ≥7% Through 16 Weeks of Treatment Stratified by Baseline Weight1


4-Study Dataset

4-Study Dataset

4-Study Dataset

6-Study Dataset

6-Study Dataset

Baseline Weight n (%)

Placebo (N=551)

BARI 2 mg (N=479)

BARI 4 mg (N=479)

Placebo (N=1070)

BARI 4 mg (N=997)

<60 kg

6 (4.7)

7 (6.7)

6 (5.9)

8 (2.8)

35 (14.1)

60 to <100 kg

6 (1.8)

16 (5.3)

9 (3.0)

13 (2.0)

28 (4.4)

100 kg

0

1 (1.4)

1 (1.5)

0

2 (2.0)

Below mediana

9 (3.3)

15 (6.3)

12 (5.2)

11 (2.0)

51 (10.1)

Above mediana

3 (1.2)

9 (3.8)

4 (1.6)

10 (2.0)

14 (2.9)

Abbreviations: BARI, baricitinib

a Baseline median weight was 73.1 kg for the 4 Study Dataset and 71.0 kg for the 6 Study Dataset.

Weight Gain with Rheumatoid Arthritis Therapy

Weight gain has been described in association with effective control of RA using DMARD therapies, including MTX and tumor necrosis factor inhibitors.2,3 Consistent with these prior findings,

  • statistically significant within group weight increases from baseline to week 52 were observed for MTX (p=.001) in the RA-BEGIN study, and

  • statistically significant between group differences in weight increase were observed for adalimumab compared to placebo at week 24 (p=.001) in the RA-BEAM study.1

Safety Dataset Descriptions

Description of the 6-Study Dataset

A 6 study safety analysis dataset compared BARI 4 mg vs placebo and included patients with RA from 3 phase 2 and 3 phase 3 studies who were randomized to BARI 4 mg (N=997) or placebo (N=1070).1

Patients in the BARI and placebo groups could have been taking

  • background MTX, or

  • in some studies, other csDMARD therapy.1

Description of the 4-Study Dataset Untitled

A 4 study safety analysis dataset compared BARI 2 mg vs BARI 4 mg vs placebo and included patients with RA from 2 phase 2 and 2 phase 3 studies who were randomized to

  • BARI 2 mg (N=479)

  • BARI 4 mg (N=479), or

  • placebo (N=551).1

Patients in the BARI and placebo groups could have been taking background MTX or other csDMARD therapy.1

References

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

2. Brown RA, Spina D, Butt S, Summers GD. Long-term effects of anti-tumour necrosis factor therapy on weight in patients with rheumatoid arthritis. Clin Rheumatol. 2012;31(3):455-461. http://dx.doi.org/10.1007/s10067-011-1863-6

3. Jurgens MS, Jacobs JW, Geenen R, et al. Increase in body mass index in a tight controlled methotrexate-based strategy with prednisone in early rheumatoid arthritis: side effect of the prednisone or better control of disease activity? Arthritis Care Res (Hoboken). 2013;65(1):88-93. http://dx.doi.org/10.1002/acr.21797

Glossary

BARI = baricitinib

BMI = body mass index

CI = Confidence Interval

csDMARD = conventional synthetic disease-modifying antirheumatic drug

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

OR = odds ratio

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 M03 02

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