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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.
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
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 |
||
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
Preferred Terms |
All BARI RA (PYE=15,114) |
Nasopharyngitis |
625 (16.6) |
Upper respiratory tract infection |
610 (16.2) |
Bronchitis |
575 (15.3) |
Urinary tract infection |
527 (14.0) |
Herpes zoster |
402 (10.7) |
Hypertension |
373 (9.9) |
Back pain |
347 (9.2) |
Influenza |
343 (9.1) |
Blood CPK increased |
338 (9.0) |
Arthralgia |
310 (8.2) |
Cough |
282 (7.5) |
Pharyngitis |
269 (7.1) |
Gastroenteritis |
237 (6.3) |
Headache |
262 (6.9) |
Hypercholesterolemia |
261 (6.9) |
Rheumatoid arthritis |
257 (6.8) |
Anemia |
252 (6.7) |
Hyperlipidemia |
242 (6.4) |
Diarrhea |
222 (5.9) |
Sinusitis |
213 (5.6) |
Pneumonia |
210 (5.6) |
Nausea |
210 (5.6) |
Osteoarthritis |
195 (5.2) |
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.
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