Olumiant® (Baricitinib)

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Baricitinib: Effect of Body Mass Index on Efficacy

Body mass index did not impact the greater improvement in clinical outcomes of baricitinib compared to placebo in patients with rheumatoid arthritis.

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Efficacy by Baseline BMI From Pooled Analysis

A pooled post hoc analysis of 2 phase 3 clinical trials in patients with RA and inadequate response to csDMARDs assessed the effect of baseline BMI on the response of BARI treatment.1

The phase 3 clinical trials included in this analysis were 

  • RA-BEAM that compared BARI 4 mg vs placebo or adalimumab, with background MTX, in patients with inadequate response to MTX.2 
  • RA-BUILD that compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with inadequate response to csDMARDs.3

Results for Baricitinib 4 mg and Placebo Groups

Baricitinib 4 mg treated patients (n=714) achieved greater improvements than placebo treated patients (n=716) in RA efficacy measures regardless of the baseline BMI tertiles of

  • <22.9 lowest BMI
  • ≥22.9 to ≤30.7 middle BMI, and
  • >30.7 highest BMI.1

Results are presented in RA-BEAM and RA-BUILD Pooled Analysis Efficacy Results by Baseline BMI.

RA-BEAM and RA-BUILD Pooled Analysis Efficacy Results by Baseline BMI4

Baseline BMI

At 12 weeks

Lowest BMI < 22.9

Middle BMI ≥22.9 to ≤30.7

Highest BMI >30.7

ACR20, n (%)

BARI 4 mg, (n=714)

160 (68.4%)

166 (68.0%)

152 (64.7%)

Placebo, (n=716)

90 (36.1%)

92 (40.4%)

104 (43.5%)

ACR50, n (%)

BARI 4 mg

103 (44.0%)

110 (45.1%)

81 (34.5%)

Placebo

36 (14.5%)

38 (16.7%)

37 (15.5%)

DAS28-hsCRPa LSM Δ from baseline (95% CI)

BARI 4 mg 

-2.6 (-2.80 to -2.30)

-2.2 (-2.37 to -1.95)

-2.0 (-2.20 to -1.83)

Placebo

-1.2 (-1.45 to -0.97)

-0.9 (-1.16 to -0.74)

-1.2 (-1.35 to -0.97)

CDAIa LSM Δ from baseline (95% CI)

BARI 4 mg

-24.1 (-26.63 to -21.61)

-21.5 (-23.73 to -19.30)

-21.3 (-23.19 to -19.34)

Placebo

-14.5 (-16.93 to -12.02)

-12.1 (-14.30 to -9.92)

-15.0 (-16.97 to -13.09)

SDAIa LSM Δ from baseline (95% CI)

BARI 4 mg

-25.8 (-28.35 to -23.16)

-22.6 (-24.92 to -20.34)

-22.3 (-24.29 to -20.33)

Placebo

-14.7 (-17.24 to -12.16)

-12.2 (-14.43 to -9.90)

-15.0 (-17.01 to -13.01)

HAQ-DIa LSM Δ from baseline (95% CI)

BARI 4 mg

-0.7 (-0.85 to -0.62)

-0.6 (-0.72 to -0.53)

-0.6 (-0.66 to -0.49)

Placebo

-0.4 (-0.51 to -0.28)

-0.3 (-0.41 to -0.22)

-0.4 (-0.46 to -0.29)

At 24 weeks

mTSS ≤0b, n (%)

BARI 4 mg

180 (81.1%)

180 (80.0%)

188 (85.5%)

Placebo

137 (60.4%)

155 (74.9%)

176 (83.8%)

Abbreviations: ACR20 = 20% improvement in American College of Rheumatology criteria; ACR50 = 50% improvement in American College of Rheumatology; BARI = baricitinib; BMI = body mass index; CDAI = Clinical Disease Activity Index; DAS28-hsCRP = Disease Activity Score - high-sensitivity C-reactive protein; HAQ-DI = Health Assessment Questionnaire-Disability Index; LSM = least squares mean; mTSS = modified Total Sharp Score; SDAI = Simplified Disease Activity Index; Δ = change.

aModified last observation carried forward.

bNo progression of structural damage.

Efficacy by Baseline BMI From RA-BEACON and RA-BUILD

RA-BEACON is a phase 3 study that compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with RA and an inadequate response to at least one TNF inhibitor, who may also have had an inadequate response to one or more non-TNF inhibitor biologic DMARDs.5

Results in Baricitinib 2 mg, Baricitinib 4 mg, and Placebo Groups

Baricitinib 2 mg treated and BARI 4 mg treated patients achieved greater improvements than placebo-treated patients in RA efficacy measures regardless of the baseline BMI tertiles of

  • <25
  • ≥25 to <30, and
  • ≥30.6

Results are presented in RA-BUILD and RA-BEACON Efficacy Results by Baseline BMI.

RA-BUILD and RA-BEACON Efficacy Results by Baseline BMI6


Baseline BMI (kg/m2)

Baseline BMI (kg/m2)

Baseline BMI (kg/m2)

Baseline BMI (kg/m2)

Baseline BMI (kg/m2)

Baseline BMI (kg/m2)


BMI <25

BMI <25

BMI ≥25 and <30

BMI ≥25 and <30

BMI ≥30

BMI ≥30

At week 12

RA-BUILDa

RA-BEACONb

RA-BUILDa

RA-BEACONb

RA-BUILDa

RA-BEACONb

ACR20, n (%)

BARI 2 mg

52 (67.5%)

27 (55.1%)

51 (73.9%)

20 (51.3%)

47 (58.0%)

38 (44.2%)

BARI 4 mg

49 (65.3%)

27 (62.8%)

45 (67.2%)

39 (62.9%)

46 (54.1%)

32 (44.4%)

Placebo

34 (42.5%)

9 (23.1%)

26 (40.6%)

18 (30.0%)

30 (35.7%)

20 (26.3%)

ACR50, n (%)

BARI 2 mg

24 (31.2%)

11 (22.4%)

26 (37.7%)

10 (25.6%)

26 (32.1%)

14 (16.3%)

BARI 4 mg

30 (40.0%)

16 (37.2%)

25 (37.3%)

21 (33.9%)

21 (24.7%)

13 (18.1%)

Placebo

10 (12.5%)

4 (10.3%)

9 (14.1%)

4 (6.7%)

10 (11.9%)

6 (7.9%)

DAS28-hsCRPc, LSM Δ from baseline (SE)

BARI 2 mg

-1.92 (0.14)

-1.48 (0.18)

-1.91 (0.14)

-1.66 (0.22)

-1.68 (0.13)

-1.47 (0.13)

BARI 4 mg

-2.09 (0.14)

-2.26 (0.20)

-2.10 (0.14)

-1.95 (0.17)

-1.62 (0.13)

-1.46 (0.14)

Placebo

-1.09 (0.14)

-0.83 (0.21)

-1.01 (0.15)

-0.84 (0.18)

-1.11 (0.13)

-0.88 (0.14)

DAS28-hsCRP ≤3.2, n (%)

BARI 2 mg

28 (36.4%)

12 (24.5%)

26 (37.7%)

14 (35.9%)

27 (33.3%)

16 (18.6%)

BARI 4 mg

39 (52.0%)

20 (46.5%)

30 (44.8%)

22 (35.5%)

20 (23.5%)

14 (19.4%)

Placebo

14 (17.5%)

2 (5.1%)

10 (15.6%)

6 (10.0%)

15 (17.9%)

7 (9.2%)

SDAI ≤ 3.3, n (%)

BARI 2 mg

6 (7.8%)

0

9 (13.0%)

1 (2.6%)

6 (7.4%)

3 (3.5%)

BARI 4 mg

8 (10.7%)

2 (4.7%)

5 (7.5%)

5 (8.1%)

7 (8.2%)

2 (2.8%)

Placebo

0

0

1 (1.6%)

2 (3.3%)

1 (1.2%)

1 (1.3%)

HAQ-DIc, LSM Δ from baseline (SE)

BARI 2 mg

-0.47 (0.06)

-0.41 (0.07)

-0.58 (0.06)

-0.42 (0.09)

-0.53 (0.06)

-0.36 (0.05)

BARI 4 mg

-0.52 (0.06)

-0.41 (0.07)

-0.54 (0.06)

-0.56 (0.07)

-0.48 (0.06)

-0.32 (0.06)

Placebo

-0.31 (0.06)

-0.14 (0.08)

-0.31 (0.06)

-0.19 (0.07)

-0.32 (0.06)

-0.22 (0.06)

Abbreviations: ACR20 = 20% improvement in American College of Rheumatology criteria; ACR50 = 50% improvement in American College of Rheumatology; BARI = baricitinib; BMI = body mass index; DAS28-hsCRP = Disease Activity Score - high-sensitivity C-reactive protein; HAQ-DI = Health Assessment Questionnaire-Disability Index; LSM = least squares mean; SDAI = Simplified Disease Activity Index; Δ = change.

aTotal N for each arm: BARI 2 mg = 229; BARI 4 mg = 227; placebo = 228.

bTotal N for each arm: BARI 2 mg = 174; BARI 4 mg = 177; Placebo = 176.

cModified last observation carried forward.

References

1Zerbini C, Muram D, Arora V, et al. Effect of BMI on baricitinib efficacy: pooled analysis from two phase 3 rheumatoid arthritis clinical trials [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/effect-of-bmi-on-baricitinib-efficacy-pooled-analysis-from-two-phase-3-rheumatoid-arthritis-clinical-trials/

2Taylor 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

3Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76(9):1634. http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1

4Zerbini C, Muram D, Arora V, et al. Effect of BMI on baricitinib efficacy: pooled analysis from two phase 2 rheumatoid arthritis clinical trials. Poster presented at: American College of Rheumatology (ACR/ARHP) Annual Meeting; November 12-16, 2016; Washington, D.C.

5Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243-1252. http://dx.doi.org/10.1056/NEJMoa1507247

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BARI = baricitinib

BMI = body mass index

csDMARD = conventional synthetic disease-modifying antirheumatic drug

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

RA = rheumatoid arthritis

TNF = tumor necrosis factor

Fecha de la última revisión: 2019 M07 10


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