Olumiant ® (baricitinib)

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What were the common side effects reported in Olumiant® (baricitinib) rheumatoid arthritis clinical trials?

Common treatment-emergent adverse events in patients treated with baricitinib generally decreased or remained stable over time.

UK_cFAQ_BAR101A_COMMON_SIDE_EFFECTS_RA
UK_cFAQ_BAR101A_COMMON_SIDE_EFFECTS_RA
en-GB

Baricitinib Common Side Effects in Rheumatoid Arthritis Clinical Trials

7-Study Placebo-Controlled Dataset

The 7-study pooled dataset included patients with rheumatoid arthritis (RA) randomized to baricitinib (BARI) 4 mg (N=1142, patient-years of exposure [PYE]=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Patients could have been taking background methotrexate (MTX) or other conventional disease-modifying antirheumatic drugs (DMARDs). Evaluation time periods included through

  • the 12-week placebo-controlled period in phase 2 studies
  • 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and
  • 24 weeks of assigned treatment or until rescue in phase 3 studies.1

Data from BARI 2 mg (N=479, patient-years of exposure [PYE]=185.8) were derived from 4 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).1

Treatment-emergent adverse events (TEAEs) occurring in ≥2% of patients in the 7-study dataset are presented in Treatment-Emergent Adverse Events Occurring in ≥2% of Patients in the 7-Study Integrated Safety Dataset by MedDRA Preferred Term up to Week 16.

  • A statistically significantly larger proportion of patients had blood creatine phosphokinase (CPK) increased, hypercholesterolemia, hyperlipidemia, and abdominal pain upper in the BARI 4-mg group compared with the placebo group.  A statistically significantly smaller proportion of patients had back pain in the BARI 4-mg group compared with the placebo group.2
  • A statistically significantly larger proportion of patients had blood CPK increased, hypertension, and abdominal pain upper in the BARI 2-mg group compared with the placebo group.2
Treatment-Emergent Adverse Events Occurring in ≥2% of Patients in the 7-Study Integrated Safety Dataset by MedDRA Preferred Term up to Week 162

Preferred Term

PBO (N=1215)

(PYE=343.5)

BARI 2 mg (N=479)

(PYE=137.3)


BARI 4 mg (N=1142)

(PYE=335.4)

BARI 4 mg vs PBO

BARI 2 mg vs PBO


n (%)

EAIR

n (%)

EAIR

n (%)

EAIR

P Valuea

P Valueab

Upper respiratory tract infection

57 (4.7)

16.6

27 (5.6)

19.7

70 (6.1)

20.9

.183

.636

Nasopharyngitis

56 (4.6)

16.3

16 (3.3)

11.7

60 (5.3)

17.9

.457

.267

Headache

40 (3.3)

11.6

30 (6.3)

21.8

43 (3.8)

12.8

.631

.180

Blood CPK increased

6 (0.5)

1.7

11 (2.3)

8.0

41 (3.6)

12.2

.001

.011

UTI

34 (2.8)

9.9

17 (3.5)

12.4

40 (3.5)

11.9

.347

.366

Anemia

35 (2.9)

10.2

8 (1.7)

5.8

32 (2.8)

9.5

.774

1.000

Bronchitis

31 (2.6)

9.0

12 (2.5)

8.7

32 (2.8)

9.5

.739

.318

Hyper-cholesterolemia

17 (1.4)

4.9

7 (1.5)

5.1

31 (2.7)

9.2

.019

.599

Hyperlipidemia

16 (1.3)

4.7

5 (1.0)

3.6

31 (2.7)

9.2

.018

.840

Nausea

17 (1.4)

4.9

13 (2.7)

9.5

28 (2.5)

8.3

.078

.629

Diarrhea

36 (3.0)

10.5

16 (3.3)

11.7

26 (2.3)

7.8

.227

.471

Cough

19 (1.6)

5.5

9 (1.9)

6.6

28 (2.5)

8.3

.141

.815

Hypertension

24 (2.0)

7.0

16 (3.3)

11.7

27 (2.4)

8.0

.605

.021

Pharyngitis

14 (1.2)

4.1

10 (2.1)

7.3

23 (2.0)

6.9

.086

.057

Abdominal pain upper

6 (0.5)

1.7

10 (2.1)

7.3

17 (1.5)

5.1

.015

.040

Rheumatoid arthritis

24 (2.0)

7.0

5 (1.0)

3.6

14 (1.2)

4.2

.123

.256

Back pain

28 (2.3)

8.2

14 (2.9)

10.2

12 (1.1)

3.6

.013

.514

Vomiting

7 (0.6)

2.0

11 (2.3)

8.0

13 (1.1)

3.9

.178

.057

Sinusitis

12 (1.0)

3.5

10 (2.1)

7.3

11 (1.0)

3.3

.941

.240

Abbreviations: BARI = baricitinib; CPK = creatine phosphokinase; EAIR = exposure adjusted incidence rate; MedDRA = Medical Dictionary for Regulatory Activities; N = number of patients in the safety analysis set; n = number of patients in specified category; PBO = placebo; PYE = patient-years of exposure; UTI = urinary tract infection.
Notes: Percentages are based on the number of patients in each treatment group (N). EAIR is expressed as the number of patients experiencing an adverse event per 100 PYE to treatment and is derived as 100 times the incidence of the event divided by the sum of all patient exposure time (in years for the specific treatment group censored at rescue). Preferred terms are sorted by decreasing frequency in the BARI 4-mg group.

aP value from Cochran-Mantel-Haenszel (CMH) test stratified by study.

bP values for the BARI 2 mg vs placebo comparison calculated using the 4-study placebo-controlled dataset placebo group consisting of 551 patients and 150.0 PYE.

All-BARI-RA Dataset

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, and RA-BALANCE). Data include a long-term extension study (RA-BEYOND) with

  • 14,744 PYE to BARI
  • 15,114 patient-years (PY) overall observation including time on BARI and follow up
  • median exposure of 4.6 years, and
  • maximum exposure of 9.3 years.3

Common Treatment-Emergent Adverse Events

Most patients (90.7%) reported ≥1 TEAE.3 The system organ classes (SOCs) with the most TEAEs were

  • infections and infestations
  • musculoskeletal and connective tissue disorders, and
  • gastrointestinal disorders.2

Treatment-Emergent Adverse Events ≥5% in the All-BARI-RA Analysis Set presents further details.

The same TEAEs that occurred relatively frequently in previous data cut submissions were also observed in the final dataset with up to 9.3 years. Generally, the exposure-adjusted incidence rate (EAIRs) per 100 patient-years for the 15 most frequently reported TEAEs decreased compared with previous submissions.2

Treatment-Emergent Adverse Events ≥5% in the All-BARI-RA Analysis Set3

Preferred Terms

All BARI RA (PYE=15,114)
N=3770

n (%)
[EAIR]

Nasopharyngitis

625 (16.6)
[4.1]

Upper respiratory tract infection

610 (16.2)
[4.0]

Bronchitis

575 (15.3)
[3.8]

Urinary tract infection

527 (14.0)
[3.5]

Herpes zoster

402 (10.7)
[2.7]

Hypertension

373 (9.9)
[2.5]

Back pain

347 (9.2)
[2.3]

Influenza

343 (9.1)
[2.3]

Blood CPK increased

338 (9.0)
[2.2]

Arthralgia

310 (8.2)
[2.1]

Cough

282 (7.5)
[1.9]

Pharyngitis

269 (7.1)
[1.8]

Gastroenteritis

237 (6.3)
[1.6]

Headache

262 (6.9)
[1.7]

Hypercholesterolemia

261 (6.9)
[1.7]

Rheumatoid arthritis

257 (6.8)
[1.7]

Anemia

252 (6.7)
[1.7]

Hyperlipidemia

242 (6.4)
[1.6]

Diarrhea

222 (5.9)
[1.5]

Sinusitis

213 (5.6)
[1.4]

Pneumonia

210 (5.6)
[1.4]

Nausea

210 (5.6)
[1.4]

Osteoarthritis

195 (5.2)
[1.3]

Abbreviations: BARI = baricitinib; CPK = creatine phosphokinase; EAIR = exposure-adjusted incidence rate; PYE = patient-years of exposure; RA = rheumatoid arthritis.

Information From the Label

The most commonly reported adverse drug reactions with baricitinib are4

  • increased LDL cholesterol (26.0 %),
  • upper respiratory tract infections (16.9 %) 
  • headache (5.2 %)
  • herpes simplex (3.2 %), and
  • urinary tract infections (2.9 %).

Serious pneumonia and serious herpes zoster occurred uncommonly in patients with rheumatoid arthritis.4

Please refer to section 4.8 of the Olumiant Summary of Product Characteristics for further information on this topic.

Please note that the frequencies of the adverse reactions are based on integrated data from4

  • clinical trials and/or
  • postmarketing setting

across

  • rheumatoid arthritis, 
  • atopic dermatitis, and
  • alopecia areata

indications unless stated otherwise.4 

References

1Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis over a median of 3 years of treatment: an updated integrated safety analysis. Lancet Rheumatol. 2020;2(6):e347-e357. https://doi.org/10.1016/S2665-9913(20)30032-1

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

3Taylor 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

4Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Date of Last Review: 10 December 2021


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