Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Insidens av hjärtsvikt i det kliniska utvecklingsprogrammet

Baserat på data från kliniska studier, är kronisk hjärtinsufficiens (CHF) inte angivet i produktresumén som biverkning för baricitinib.

Information from the label

CHF is not listed amont the adverse events reported in the summary of product characteristics.1

Congestive Heart Failure Reported in the Rheumatoid Arthritis Clinical Program

Congestive Heart Failure Event Identification in the All BARI RA Dataset

Cases of CHF were identiifed based on the MedDRA Cardiac Failure SMQ (#20000004).2

  • Broad terms included all possible events indicative of cardiac failure according to MedDRA version 20.0. 

  • Narrow terms were those that were highly likely to represent CHF. 

Incidence of Congestive Heart Failure in the Baricitinib Rheumatoid Arthritis Clinical Development Program

The integrated analysis datasets used to evaluate congestive heart failure are described in more detail inTable 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.3

7-Study Placebo-Controlled Dataset

Treatment-Emergent Adverse Events

At week 24, the following number of patients had a reported TEAE of CHF using broad terms

  • 17 patients (EAIR = 3.77) in the placebo group,

  • 7 patients (EAIR = 3.77) in the BARI 2-mg group, and

  • 13 patients (EAIR = 2.76) in the BARI 4-mg group.4

At week 24, the following number of patients had a reported TEAE of CHF using narrow terms

  • 1 patient (EAIR = 0.22) in the placebo group,

  • 0 patients in the BARI 2-mg group, and

  • 1 patient (EAIR = 0.21) in the BARI 4-mg group. 4

Serious Adverse Events

Using both broad and narrow terms, there were no SAEs of CHF in either the placebo group or the BARI 2-mg treatment group through week 24. There was 1 SAE of cardiac failure in the BARI 4-mg treatment group, with an EAIR of 0.2.4

4-Study Extended Dataset

Treatment Emergent Adverse Events

Through 13 February 2018,  the following number of patients (EAIR) had a reported TEAE of CHF using broad terms

  • 12 patients (EAIR = 1.8) in the BARI 2-mg group, and

  • 19 patients (EAIR = 2.7) in the BARI 4-mg group.4

Through 13 February 2018,  the following number of patients (EAIR) had a reported TEAE of CHF using narrow terms

  • 3 patients (EAIR = 0.4) in the BARI 2-mg group, and

  • 1 patient (EAIR = 0.1) in the BARI 4-mg group. 4

Serious Adverse Events

Through 13 February 2018,  the following number of patients (EAIR) had a reported SAE of CHF using

  • broad terms

    • 1 patient (EAIR = 0.1) in the BARI 2-mg group, and

    • 1 patient (EAIR = 0.1) in the BARI 4-mg group.4

  • narrow terms

    • 1 patient (EAIR = 0.1) in the BARI 2-mg group, and

    • 1 patient (EAIR = 0.1) in the BARI 4-mg group.4

All BARI RA Dataset

Treatment Emergent Adverse Events

Through 13 February 2018,  133 patients (EAIR = 1.3) had a reported TEAE of CHF using broad terms, and 23 patients (EAIR = 0.2) had a reported TEAE of CHF using narrow terms.4

Serious Adverse Events

Through 13 February 2018, 12 patients (EAIR = 0.1) had a reported SAE of CHF using broad terms, and 12 (EAIR = 0.1) patients had a reported SAE of CHF using narrow terms.4

Table 1. Integrated Analysis Datasets Used to Evaluate Safety3-5

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, PYE=471.8), or

  • placebo (N=1215, PYE=450.8).

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, PYE=185.8) 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), or 

  • BARI 2 mg (N=479, PYE=675.6).

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) 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, including

  • BARI 4 mg (n=3392)

  • BARI 2 mg (n=1068), and

  • BARI 1 mg, 7 mg, 8 mg, and 10 mg QD doses not evaluated in confirmatory studies.

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.

References

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

2. Taylor PC, Weinblatt ME, Burmester GR, et al. Cardiovascular safety during treatment with baricitinib in rheumatoid arthritis [published online January 21, 2019]. Arthritis Rheumatol. https://dx.doi.org/10.1002/art.40841

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. Presented as an oral presentation at: European League Against Rheumatism (EULAR) Annual Meeting; June 12-15, 2019; Madrid, Spain.

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

5. 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

Glossary

BARI = baricitinib

CHF = congestive heart failure

EAIR = exposure-adjusted incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

RA = rheumatoid arthritis

SAE = serious adverse event

SMQ = standardized MedDRA query

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 2019 M06 14

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