Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Incidens av eosinofili eller ökat eosinofiltal i utvecklingsprogrammet för reumatoid artrit

I baricitinib reumatoid utvecklingsprogram för artrit sågs eosinofili hos 16 [EAIR 0,1] patienter och antalet eosinofiler ökade hos 8 [EAIR 0,1] patienter.

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Eosinophil Counts

Absolute eosinophil counts was part of the planned clinical laboratory tests for the pivotal phase 3 RA trials for BARI.1

Baricitinib Rheumatoid Arthritis Phase 3 Clinical Trial Exclusion Criteria

No reference range for eosinophils was specified in the protocol exclusion criterion in the pivotal phase 3 BARI trials in RA: RA-BEAM, RA-BEACON, RA-BUILD, and RA-BEGIN. However, patients were excluded if they had screening laboratory test values outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the patient’s participation in the study.1

Incidence of Eosinophilia or Eosinophil Count Increased in the Rheumatoid Arthritis Clinical Development Program

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

6-Study Placebo-Controlled Dataset

Description

The 6-study placebo-controlled dataset compared BARI 4 mg vs placebo and included patients with RA who were randomized to BARI 4 mg (N=997) or placebo (N=1070) from 3 phase 2 and 3 phase 3 studies. In the majority of the studies, patients were on background therapy either with MTX or another csDMARD. The BARI 2-mg data is derived from 4 studies in which both BARI 2 mg (N=479) and BARI 4 mg were options during randomization.2

Difference in Eosinophil Counts

At endpoint (up to 16 weeks), a smaller proportion of patients in the BARI 4-mg group had abnormal high eosinophil counts vs placebo (Changes in Eosinophil Counts in the Baricitinib 4 mg Rheumatoid Arthritis Placebo-Controlled Trials Up to 16 Weeks).1

Changes in Eosinophil Counts in the Baricitinib 4 mg Rheumatoid Arthritis Placebo-Controlled Trials Up to 16 Weeks1

Eosinophils (Billion Cells/L)

Baseline, Mean (SD)

Change From Baseline, LSM (SE)

Change From Baseline (95% CI)

Difference in LSM Between BARI 4-mg and PBO for Change From Baseline

BARI 4 mg (n=997)

0.144 (0.142)

-0.038 (0.0045)

(-0.047, -0.029)

-0.042a

PBO (n=1068)

0.136 (0.12)

0.004 (0.0043)

(-0.004, 0.012)

--

Abbreviations: BARI = baricitinib; LSM = least squares mean; PBO = placebo.

ap≤.05.

7-Study Placebo-Controlled 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.3

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).3

Incidence of Eosinophilia or Eosinophil Count Increased in the 7-Study Placebo Controlled Analysis Set

In this safety analysis, through 24 weeks of treatment, TEAEs of eosinophil count increased and eosinophilia are shown in Incidence of Eosinophilia/Eosinophil Count Increased in the BARI Safety Analysis, Through 24 Weeks.

Incidence of Eosinophilia/Eosinophil Count Increased in the BARI Safety Analysis, Through 24 Weeks

n (%) [EAIR]

BARI 4 mg (n=1142)

BARI 2 mg (n=479)

PBO (n=1215)

Eosinophil count increased

0

0

2 (0.2) [0.4]

Eosinophilia

3 (0.3) [0.6]

1 (0.2) [0.5]

1 (0.1) [0.2]

Abbreviations: BARI = baricitinib; EAIR = exposure-adjusted incidence rate; PBO = placebo.

All Baricitinib Rheumatoid Arthritis Analysis 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, 2019.4,5

Incidence of Eosinophilia or Eosinophil Count Increased in the All Baricitinib Rheumatoid Arthritis Analysis Set

In the All BARI RA analysis set through September 1, 2019, a TEAE of eosinophilia or eosinophil count increased was reported in 24 patients.1

None of the 24 TEAEs of eosinophilia or eosinophil count increased were reported as serious. For more information on events, see Incidence of Eosinophilia or Eosinophil Count Increased in the All BARI RA Analysis Set.1

Incidence of Eosinophilia or Eosinophil Count Increased in the All BARI RA Analysis Set1

n (%) [EAIR]

TEAE

Temporary Interruption

Permanent Discontinuation

Eosinophilia

16 (0.4) [0.1]

1 (0.0) [0.0]

1 (0.0) [0.0]

Eosinophil count increased

8 (0.2) [0.1]

0

0

Abbreviations: EAIR = exposure-adjusted incidence rate; TEAE = treatment-emergent adverse event.

References

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

2Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment. J Rheumatol. 2019;46(1):7-18. http://dx.doi.org/10.3899/jrheum.171361

3Genovese 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

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 [abstract]. Ann Rheum Dis. 2020;79(suppl 1):638. https://ard.bmj.com/content/79/Suppl_1/642.1

5Genovese 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

csDMARD = conventional synthetic disease-modifying antirheumatic drug

DMARD = disease-modifying antirheumatic drug

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 M08 20


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