Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Överkänslighetsreaktioner

Utslag, ansiktssvullnad och urtikaria har inkluderats som biverkningar av baricitinib. Fall av läkemedelsöverkänslighet associerats till baricitinibadministration har också rapporterats.

Information from the label

Baricitinib is contraindicated in case of hypersensitivity to the active substance or to any of the excipients.1

In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported. If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.1

Cases of rash, urticaria, and facial swelling associated with BARI administration have been reported.1

Rash was reported as a common event (≥1% and <10%) within skin and subcutaneous tissue disorders in patients treated with BARI in clinical trials. Urticaria and face swelling were reported as uncommon events (infrequent ≥0.1% and <1%) within skin and subcutaneous tissue disorders in patients treated with BARI in clinical trials.1

Rash, Urticaria, Facial Swelling, and Hypersensitivity in the Baricitinib Clinical Development Program

The integrated datasets used to evaluate rash, urticaria, facial, and hypersensitivity swelling reactions are described in Table 1.

Exposure-adjusted incidence rates were calculated as the number of patients with an event per 100 patient-years of exposure time, with exposure not censored at time of event.2

Table 1. Integrated Analysis Datasets Used to Evaluate Safety2-4

Analysis Set

Descriptiona

7-Study Placebo-Controlled Dataset

Studies: JADC, JADA, JADN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE

Compares BARI 4 mg vs placebo

Includes patients with RA from 3 phase 2 and 4 phase 3 studies who were randomized to

  • BARI 4 mg (N=1142, [exposure through 24 weeks: PYE=471.8, median exposure=169 days, maximum exposure=211 days]), or

  • placebo (N=1215, [exposure through 24 weeks: PYE=450.8, median exposure=166 days, maximum exposure=235 days]).

Patients in the placebo group could have been taking

  • background MTX, or

  • in some studies, other conventional DMARD therapy.

Evaluation time periods included

  • through the 12-week placebo-controlled period in phase 2 studies

  • through 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and

  • through 24 weeks of assigned treatment or until rescue in phase 3 studies.

BARI 2 mg Analysis Set

BARI 2 mg data is derived from 4 studies in which both BARI 2 mg (N=479, [exposure through 24 weeks: PYE=185.8, median exposure=168 days, maximum exposure=197 days]) and BARI 4 mg were options during randomization (JADA, JADN, RA-BUILD, RA-BEACON).

4-Study Extended Dataset

Studies: JADA, JADN, RA-BUILD, RA-BEACON, RA-BEYOND (extension)

Compares BARI 4 mg vs BARI 2 mg including extended evaluations

Includes patients with RA from 2 phase 2 and 2 phase 3 studies and any further exposure for those patients in the phase 3 extension study, RA-BEYOND, who were randomized to

  • BARI 4 mg (N=479, PYE=698.6, median exposure=342 days, maximum exposure=2520 days), or

  • BARI 2 mg (N=479, PYE=675.6, median exposure=257 days, maximum exposure=1805 days).

Evaluation time period included randomization through last available observation incorporating extension data through 13 February 2018 unless otherwise specified.

All BARI RA Dataset

Studies: JADB, JADC, JADA, JADN, RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE, RA-BEYOND (extension)

No between-group comparisons

Includes patients with RA (N=3770, PYE=10,127, median exposure=1115 days [3.1 yrs], maximum exposure=2520 days [6.9 yrs]) from 1 phase 1, 3 phase 2, 5 phase 3 studies, and 1 phase 3 extension study who received BARI at a variety of doses.

Patients had to have received at least 1 dose of BARI and could have received different doses throughout the trials.

Evaluation time period is all exposure time points including after rescue or changes in study drug through 13 February 2018 unless otherwise specified.

Abbreviations: BARI = baricitinib; DMARD = disease-modifying antirheumatic drug; MTX = methotrexate; PYE = patient-years of exposure; QD = once daily; RA = rheumatoid arthritis.

a Patients with renal function impairment who were randomized to BARI 4 mg, but treated with the 2-mg dose were analyzed in the BARI 4-mg group.

The study population of DMARD-naïve patients from the RA-BEGIN study is not included in the approved label. However, the RA-BEGIN study is supportive for the target population of patients with an inadequate response to, or intolerance to, other DMARDs.1

Treatment-Emergent Adverse Events Including Rash, Urticaria, Facial Swelling, and Hypersensitivity

The integrated datasets were used to evaluate rash, urticaria, facial swelling and hypersensitivity. Data for rash, urticaria, and facial swelling were reported based on individual MedDRA preferred terms and are included as part of hypersensitivity incidence data. The majority of the events that resulted from this query were likely not related to BARI as they occurred more than 2 weeks after the start of BARI. Data for hypersensitivity were searched based on the Hypersensitivity Standardized Medical Dictionary for Regulatory Authorities Queries (SMQ) (narrow), which included the following MedDRA preferred queries

  • anaphylactic reaction SMQ (narrow),

  • angioedema SMQ (narrow), and

  • severe cutaneous adverse reactions SMQ (narrow) Table 2.4

Table 2. Treatment-Emergent AE's including Hypersensitivity, Rash, Urticaria, and Facial Swelling4

N (%) [EAIR]

Rash

Urticaria

Facial Swelling

Anaphylactic Reaction

Hypersensitivity

7-Study Placebo-Controlled Dataset (weeks 0-16)

Placebo (N=1215)

9 (0.7) [2.6]

1 (0.1) [0.29]

1 (0.1) [0.29]

0

45 (3.7) [13.1]

BARI 2 mg (N=479)

13 (2.7) [1.9]

3 (0.6) [0.4]

0

0

33 (6.9) [4.9]

BARI 4 mg (N=1142)

9 (0.8) [2.7]

2 (0.2) [0.60]

3 (0.3) [0.89]

0

36 (3.2) [10.7]

All BARI RA (through February 13, 2018; N=3770)

n (%) [EAIR]

97 (2.6) [0.96]

31 (0.8) [0.31]

5 (0.1) [0.05]

0

359 (9.5) [3.6]

Abbreviations: AEs = adverse event; BARI = baricitinib; EAIR = exposure-adjusted incidence rate; RA = rheumatoid arthritis.

References

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

2. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Presented as an oral presentation at: European League Against Rheumatism (EULAR) Annual Meeting; June 12-15, 2019; Madrid, Spain.

3. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Ann Rheum Dis. 2019;78(2):308-309. http://dx.doi.org/10.1136/annrheumdis-2019-eular.691

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

Glossary

AE = adverse event

BARI = baricitinib

Lilly = Eli Lilly and Company

MedDRA = Medical Dictionary for Regulatory Activities

SMQ = standardized MedDRA query

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 2019 M09 16


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