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Olumiant ® (baricitinib) tabletter
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
Treatment-Emergent Adverse Events
A 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
7-Study Placebo-Controlled Dataset
Dataset Description
The 7-study pooled dataset included patients with RA randomized to BARI 4 mg (N=1142, 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 MTX or other conventional 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.2
Data from BARI 2 mg (N=479, 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).2
Incidence of Eye Disorders
Through 24 weeks of treatment, TEAE categorized as eye disorders were reported in
35 (3.1%) patients in the BARI 4 mg group
13 (2.7%) patients in the BARI 2 mg group, and
35 (2.9%) patients in the placebo group.1
The most commonly reported eye disorders in any treatment group are presented in Table 1.
Table 1. 7-Study Pooled Dataset: Incidence of Eye Disorders Occurring in ≥0.2% of Patients in Any Treatment Group Through 24-Weeks of Treatment1
n (%) |
PBO (n=1215) |
BARI 4 mg (n=1142) |
BARI 2 mg (n=479) |
Eye disorders |
35 (2.9) |
35 (3.1) |
13 (2.7) |
Dry eye |
6 (0.5) |
8 (0.7) |
2 (0.4) |
Cataract |
7 (0.6) |
6 (0.5) |
2 (0.4) |
Vision blurred |
2 (0.2) |
5 (0.4) |
1 (0.2) |
Conjunctival hemorrhage |
3 (0.2) |
1 (0.1) |
0 |
Conjunctivitis allergic |
2 (0.2) |
1 (0.1) |
1 (0.2) |
Visual impairment |
0 |
2 (0.2) |
0 |
Vitreous floaters |
0 |
2 (0.2) |
0 |
Glaucoma |
1 (0.1) |
1 (0.1) |
1 (0.2) |
Lacrimation Increased |
1 (0.1) |
1 (0.1) |
1 (0.2) |
Keratitis |
1 (0.1) |
0 |
1 (0.2) |
Eye discharge |
0 |
0 |
1 (0.2) |
Iritis |
0 |
0 |
1 (0.2) |
Ocular Discomfort |
0 |
0 |
1 (0.2) |
Pinguecula |
0 |
0 |
1 (0.2) |
Posterior capsule opacification |
0 |
0 |
1 (0.2) |
Retinal vascular thrombosis |
0 |
0 |
1 (0.2) |
Abbreviations: BARI = baricitinib; PBO = placebo.
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, and 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
Incidence of Eye Disorders
In the All BARI RA analysis set through September 1, 2019, TEAEs categorized as eye disorders were reported in 361 (9.6%, EAIR=2.7) patients.1
Of these 361 eye disorder related TEAEs
21 were reported as serious adverse events
12 resulted in temporary interruption of BARI, and
0 resulted in permanent discontinuation of BARI.1
The incidence of most common eye disorders reported in the All BARI RA analysis set through September 1, 2019 can be seen in Table 2.
Table 2. All BARI RA Dataset: Incidence of Eye Disorders Occurring in ≥0.2% of Patients1
n (%) [EAIR] |
TEAE |
SAE |
TI |
Eye disorders |
361 (9.6) [2.7] |
21 (0.6) [0.2] |
12 (0.3) [0.1] |
Cataract |
98 (2.6) [0.7] |
13 (0.3) [0.1] |
7 (0.2) [0.1] |
Dry eye |
69 (1.8) [0.5] |
0 |
0 |
Glaucoma |
22 (0.6) [0.2] |
1 (0.0) [0.01] |
0 |
Conjunctivitis allergic |
19 (0.5) [0.1] |
0 |
0 |
Vision blurred |
17 (0.5) [0.1] |
0 |
0 |
Blepharitis |
10 (0.3) [0.1] |
0 |
0 |
Vitreous floaters |
10 (0.3) [0.1] |
0 |
0 |
Xerophthalmia |
10 (0.3) [0.1] |
0 |
0 |
Conjunctival hemorrhage |
7 (0.2) [0.1] |
0 |
0 |
Keratitis |
7 (0.2) [0.1] |
1 (0.0) [0.01] |
0 |
Ocular hyperemia |
6 (0.2) [0.0] |
0 |
0 |
Abbreviations: EAIR = exposure-adjusted incidence rate; SAE = serious adverse event; TEAE = treatment emergent adverse event; TI = temporary interruption.
1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2. Genovese 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
3. Genovese 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
4. Genovese 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.
Glossary
BARI = baricitinib
DMARD = disease-modifying antirheumatic drug
EAIR = exposure-adjusted incidence rate
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 2020 M07 24