Olumiant ® (baricitinib)

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Does Olumiant® (baricitinib) cause weight gain in patients treated for rheumatoid arthritis?

With baricitinib, weight gain is an uncommon adverse drug effect (≥0.1% and <1%).

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Incidence of Treatment-Emergent Weight Gain in the Rheumatoid Arthritis Clinical Trials

A treatment-emergent adverse event (TEAE) is an adverse event that either occurred or worsened in severity after the first dose of study treatment and did not necessarily have a causal relationship to study treatment.1

Baricitinib vs Placebo 6-Study Dataset

A 6 study safety analysis dataset compared baricitinib 4 mg vs placebo and included patients with rheumatoid arthritis (RA) from 3 phase 2 and 3 phase 3 studies who were randomized to baricitinib 4 mg (N=997) or placebo (N=1070). Patients in the baricitinib and placebo groups could have been taking

  • background methotrexate (MTX), or
  • in some studies, other conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy.1

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

  • 0.6% in the baricitinib 4 mg group, and
  • 0.5% in the placebo group.1

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

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

  • baricitinib 2 mg (N=479)
  • baricitinib 4 mg (N=479), or
  • placebo (N=551).1

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

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

  • 0.8% in the baricitinib 4 mg group
  • 0.8% in the baricitinib 2 mg group, and
  • 0.4% in the placebo group.1

All BARI RA Dataset

The All BARI RA analysis set included 3770 patients with RA who received baricitinib 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, and RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with

  • 14,744 patient-years exposure to baricitinib
  • 15,114 patient-years overall observation including time on baricitinib and follow up
  • median exposure of 4.6 years, and
  • maximum exposure of 9.3 years.2

Events of weight increased are from preferred terms "weight increased" and "overweight."1

In the All BARI RA dataset, a total of 1.9% (exposure-adjusted incidence rate [EAIR] 0.46) of patients reported the TEAE of weight increased. Weight gain was mainly present during the first 2 years after treatment initiation (Treatment-Emergent Weight Increased (Preferred Term) by Time Periods in the All BARI RA Analysis Set).1

Treatment-Emergent Weight Increased (Preferred Term) by Time Periods in the All BARI RA Analysis Set1

Figure description: The incidence rate per 100 patient years of treatment-emergent weight was greatest from weeks 0-48 at 1.1%, with the incidence rate decreasing over time to 0.0% at >336 weeks.

Abbreviations: BARI = baricitinib; NAR = number of patients at risk; PYR = patient-years at risk; RA = rheumatoid arthritis.

Abnormal Weight Increase 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 baricitinib 4 mg compared to placebo for patients in all size strata.1 Details presented in Weight Gain ≥7% Through 16 Weeks of Treatment Stratified by Baseline Weight.

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

  • body weight <60 kg (odds ratio [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
  • body mass index (BMI) <25 kg/m2 (OR=5.0 and CI [2.5, 10.0]).1

In the baricitinib 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 baricitinib 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 baricitinib 2-mg group and the

  • placebo group, and
  • baricitinib 4-mg group.1

For the proportion of patients with abnormal weight gain by strata refer to Weight Gain ≥7% Through 16 Weeks of Treatment Stratified by Baseline Weight

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

aBaseline 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 disease modifying antirheumatic drug (DMARD) therapies, including MTX and tumor necrosis factor inhibitors.3,4 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

References

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

2Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022;81(3):335-343. https://doi.org/10.1136/annrheumdis-2021-221276

3Brown 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

4Jurgens 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

Date of Last Review: 24 June 2022


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