Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Jämförelser med Placebo och Adalimumab i RA-BEAM Studien

Baricitinib (BARI) konstaterades vara överlägsen adalimumab vid vecka 12 baserat på förbättring i ACR20 response (gated sekundary endpoint).

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 RA clinical program that included a bDMARD as an active comparator.1

In this 52-week trial, 1307 patients with active RA and inadequate response to prior established MTX were randomized 3:3:2 to receive

  • placebo

  • BARI 4 mg daily, or

  • ADA 40 mg biweekly.1

The study was conducted using innovator ADA as the active comparator.1

Patients continued to receive methotrexate at a stable dose as background therapy. Additionally, patients were

  • permitted to receive 1 additional csDMARD, either sulfasalazine or hydroxycholoroquine

  • provided rescue therapy with BARI 4 mg starting at week 16 if they were nonresponders, and

  • switched to BARI 4 mg at week 24 if initially randomized to placebo.1

One thousand three-hundred five patients qualified for analysis.1

Two comparisons between BARI and adalimumab 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 DAS28-hsCRP.1

Results of the Gated Secondary Efficacy Analyses in RA-BEAM

A statistically significant improvement was observed in the BARI 4-mg group compared with the ADA group at week 12 for ACR20 response (70% vs 61%, p≤.05; Table 1).

  • Given that the lower bound of the 95% CI for the response rate difference between the BARI 4-mg group and ADA group was >-12%, it was concluded that the BARI 4-mg group was non-inferior to ADA group based on ACR20 response at week 12.

  • Furthermore, given that the lower bound of the 95% CI was >0%, BARI 4-mg group was also concluded to be superior to ADA group based on ACR20 response at week 12.1

Superiority was also observed in the BARI group compared with the ADA group at week 12 for DAS28-hsCRP (p<.001; Table 1). The least square mean change was

  • -2.24 for the BARI group, and

  • -1.95 for ADA group.1

Table 1. Secondary Endpoints in RA-BEAM1,2

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

70ab

37

66a

74ab

62

71c

LSM Change in DAS28-hsCRP

-0.98

-1.95a

-2.24ad

-1.13

-2.27a

-2.53ac

-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.

Safety Comparisons

Through 24 weeks, TEAEs were reported by

  • 60% of patients in the PBO group

  • 68% of patients in the adalimumab group, and

  • 71% of patients in the BARI group.1

Through 24 weeks, SAEs were reported by

  • 5% of patients in the PBO group

  • 2% of patients in the adalimumab group, and

  • 5% of patients in the BARI group.1

Rates of serious infection events were similar across the treatment groups. Three non-serious infections considered to be potentially opportunistic were reported with

  • 2 cases of esophageal candidiasis in the BARI 4-mg group, and

  • 1 case of tuberculosis in the ADA group.1

Therapeutic Indication

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.3

References

1. 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. http://dx.doi.org/10.1056/NEJMoa1608345

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

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

Glossary

ACR20 = 20% improvement in American College of Rheumatology criteria

ADA = adalimumab

BARI = baricitinib

bDMARD = biologic disease-modifying antirheumatic drug

csDMARD = conventional synthetic disease-modifying antirheumatic drug

DAS28-hsCRP = Disease Activity Score based on high-sensitivity C-reactive protein

MTX = methotrexate

RA = rheumatoid arthritis

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 M07 16


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