Olumiant® (Baricitinib)

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Baricitinib: Incidence of Eye Disorders in the RA Clinical Development Program

In the baricitinib rheumatoid arthritis clinical development program, 361 (EAIR=2.7) patients reported an eye disorder as a treatment emergent adverse event.

MX_cFAQ_BAR116A_EYE_DISORDERS_TEAE_RA
MX_cFAQ_BAR116A_EYE_DISORDERS_TEAE_RA
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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
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.

All BARI RA Analysis Set

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
  • data through September 1, 2019.3,4

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 All BARI RA Dataset: Incidence of Eye Disorders Occurring in ≥0.2% of Patients.

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.

References

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

2Genovese 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

3Genovese 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

4Genovese 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

Fecha de la última revisión: 2020 M07 24


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