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Olumiant ® ▼ (baricitinib)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information:
Olumiant Summary of Product Characteristics (SmPC)
Olumiant® ▼ (baricitinib): Incidence of Rheumatoid Nodules in Atopic Dermatitis
The effect of baricitinib on rheumatoid nodules was not evaluated in the atopic dermatitis clinical trials and there were no treatment-emergent adverse events of rheumatoid nodules in atopic dermatitis patients treated with baricitinib.
Effect
of Baricitinib on Rheumatoid Nodules
An
analysis of the effect of BARI treatment on rheumatoid nodules has
not been conducted within the BREEZE-AD clinical development
program.1
Incidence
of Rheumatoid Nodules in the BREEZE-AD Clinical Development Program
The
integrated datasets used to evaluate incidence of rheumatoid nodules
are described in more detail in Table
1.
Incidence
of Rheumatoid Nodules
There
were no reports of rheumatoid nodules as a TEAE in patients who
received BARI.1
Integrated
Safety Dataset Table
Table
1. Integrated Analysis Datasets Used to Evaluate Safety in Atopic
Dermatitis Clinical Trials1
Analysis
Set
Description
BARI
2 mg Placebo-Controlled
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, BREEZE- AD5, and
BREEZE-AD7
Compares
BARI 2 mg vs placebo
Includes
patients with AD from 1 phase 2 and 5 phase 3 studies who were
randomized to
BARI
2 mg (n=721, PYE =210.6), or
placebo
(n=889, PYE=252.7).
Treatment
period is 0 to 16 weeks.
BARI
4 mg Placebo-Controlled
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, and BREEZE-AD7
Compares
BARI 4 mg vs placebo
Includes
patients with AD from 1 phase 2 and 4 phase 3 studies who were
randomized to
BARI
4 mg (n=489, PYE=147.1), or
placebo
(n=743, PYE=211.8).
Treatment
period is 0 to 16 weeks.
BARI
2 mg vs 4 mg
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, and BREEZE-AD7
Compares
BARI 2 mg vs BARI 4 mg through 16 weeks
Includes
patients with AD from 1 phase 2 and 4 phase 3 studies who were
randomized to
BARI
2 mg (n=576, PYE=169.1), or
BARI
4 mg (n=489, PYE=147.1).
Treatment
is 0 to 16 weeks during the placebo-controlled period.
BARI
2 mg vs 4 mg Extended
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD7, and
extension study BREEZE-AD3
Compares
BARI 2 mg vs BARI 4 mg including extended evaluations
Includes
patients with AD from 1 phase 2 and 4 phase 3 studies and any
further exposure for those patients in the phase 3 extension
study, BREEZE-AD3, who were randomized to
BARI
2 mg (n=576, PYE=425.5), or
BARI
4 mg (n=489, PYE=459.3).
Treatment
period is 0 to 16 weeks.
Data
censored at dose or treatment change (rescue, dose switch, or
re-randomization to a different BARI dose or placebo) for
BREEZE-AD4 and BREEZE-AD3.
Includes
2531 (total PYE=2247.4) patients with AD from 1 phase 2, 5 phase
3, and 2 phase 3 extension studies who received BARI at a variety
of doses, including
BARI
1 mg (n=538, PYE=245.9)
BARI
2 mg (n=1580, PYE=1129.5), and
BARI
4 mg (n=914, PYE=872.8).
Includes
all patients who were exposed to any BARI dose at any time during
the studies, either from randomization or from switch or rescue
from placebo.
No
censoring of data at dose change.
Abbreviations:
AD = atopic dermatitis; BARI = baricitinib; PYE = patient years of
exposure.
Note:
BARI 1 mg was studied in pivotal trials, however it is not approved.
Please refer to section 4.2 of the Olumiant Summary of Product
Characteristics for approved dosage.
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
AD =
atopic dermatitis
BARI
= baricitinib
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.
Date of Last Review:August 03, 2020
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