Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Olumiant ▼ (baricitinib): Jämförelse med placebo och adalimumab i RA-BEAM Studien

Baricitinib (BARI) konstaterades vara överlägsen adalimumab (ADA) vid vecka 12 baserat på den sekundära ändpunkten, förbättring av ACR20-responsen.

Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate (Olumiant Summary of Product Characteristics).

Baricitinib (BARI) was concluded to be superior to adalimumab (ADA) at week 12 based on the gated secondary endpoint, improvement in American College of Rheumatology 20% response criteria (ACR20) (Taylor, 2017).

RA-BEAM: Baricitinib Vs Placebo or Adalimumab in Patients With Inadequate Response to Methotrexate

RA-BEAM was the only phase 3 study in the BARI rheumatoid arthritis (RA) clinical program that included a biologic disease-modifying antirheumatic drug as an active comparator. In this 52-week trial, 1307 patients with active RA and inadequate response to prior established methotrexate (MTX) were randomized 3:3:2 to receive

  • placebo (PBO)

  • BARI 4 mg daily, or

  • ADA 40 mg every other week (Taylor, 2017).

The study was conducted using innovator ADA as the active comparator. Patients continued to receive MTX at a stable dose as background therapy (Taylor, 2017).

One thousand three hundred five patients qualified for analysis (Taylor, 2017).

Two comparisons between BARI and ADA were analyzed as part of a gated testing strategy to control the overall type 1 error rate; all other comparisons were exploratory. The 2 gated analyses conducted at week 12 were

  • non-inferiority comparisons for ACR20 response rates, and

  • superiority comparisons for

    • ACR20 response, and

    • change in the 28-joint Disease Activity Score based on high‑sensitivity C‑reactive protein (DAS28-hsCRP) (Taylor, 2017).

Results of the Gated Secondary Efficacy Analyses in RA-BEAM

A statistically significant improvement in ACR20 response was observed in the BARI group compared with the ADA group at week 12 (Table 1). Given that the lower bound of the 95% confidence interval (CI) for the response rate difference between BARI and ADA was greater than -12%, it was concluded that BARI was non‑inferior to ADA based ACR20 at week 12. Furthermore, given that the lower bound of the 95% CI was greater than 0%, BARI was also concluded to be superior to ADA based on ACR20 response at week 12 (Taylor, 2017).

A statistically significant improvement in DAS28-hsCRP was also observed in the BARI group compared with the ADA group at week 12 (Table 1) (Taylor, 2017).

Safety Comparisons

Through 24 weeks, treatment-emergent adverse events were reported by

  • 60% of patients in the PBO group

  • 68% of patients in the ADA group, and

  • 71% of patients in the BARI group (Taylor, 2017).


Through 24 weeks, serious adverse events were reported by

  • 5% of patients in the PBO group

  • 2% of patients in the ADA group, and

  • 5% of patients in the BARI group (Taylor, 2017).

Rates of serious infection were similar across treatment groups (Taylor, 2017).

Table 1. Secondary Endpoints in RA-BEAM (Taylor, 2017; Data on file)

Efficacy assessment

12 Weeks

24 Weeks

52 Weeks

PBO

N=488

ADA

N=330

BARI

N=487

PBO

N=488

ADA

N=330

BARI

N=487

ADA

N=330

BARI

N=487

ACR20, %

40

61a

70a,b

37

66a

74a,b

62

71c

DAS28-hsCRP

LSM change

-0.98

-1.95a

-2.24a,d

-1.13

-2.27a

-2.53a,c

-2.33

-2.68d

Abbreviations: ACR20, American College of Rheumatology 20% response criteria; ADA, adalimumab; BARI, baricitinib; DAS28-hsCRP, 28-joint Disease Activity Score based on high-sensitivity C-reactive protein; LSM, least squares mean. Note: Data are % of patients (non-responder imputation), unless otherwise stated.

a p≤.001 vs placebo.

b p≤.05 vs ADA.

c p≤.01 vs ADA.

d p≤.001 vs ADA.

References

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

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

Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652-662.



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 2017 M08 04

Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss