ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2632

Effects of Baseline Patient Characteristics on Baricitinib Efficacy in Patients with Rheumatoid Arthritis

Joel M. Kremer1, Mark C. Genovese2, David Muram3, Jinglin Zhong4, Jahangir Alam3 and Michael Schiff5, 1Albany Medical College, Albany, NY, 2Stanford University Medical Center, Palo Alto, CA, 3Eli Lilly and Company, Indianapolis, IN, 4Quintiles, Rockville, MD, 5Rheumatology, University of Colorado, Denver, CO

Meeting: ACR/ARHP Annual Meeting 2016

Date of first publication: September 28, 2016

Keywords:

Session Information

Date: Tuesday, November 15, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose : This analysis assessed the effects of baseline patient characteristics on the response to baricitinib treatment in patients with rheumatoid arthritis (RA) and incomplete responses to conventional disease-modifying antirheumatic drugs (cDMARDs).

Methods: This post hoc analysis used pooled data from two phase 3, double-blind, randomized, controlled trials of 6-12 months’ duration in patients with RA and an incomplete response to cDMARDs. Pooled clinical outcome data (e.g., ACR20 response, change from baseline in DAS28-hsCRP score, percent of patients who achieved SDAI score ≤11) for patients who received baricitinib 4 mg or placebo were summarized based on categories of baseline characteristics: age, gender, ethnicity, baseline disease activity, RF/ACPA serology, and time from RA diagnosis.

Results: Patients who received baricitinib 4 mg (n=714) achieved improved clinical outcomes compared to those who received placebo (n=716) in these trials, regardless of baseline characteristic subgroup (Table). No clear pattern emerged suggesting that any baseline characteristic, including age, gender, ethnicity, RF/ACPA serology, or disease activity at baseline, had a consistent effect on baricitinib efficacy.

Conclusion: No baseline characteristics were found to abrogate baricitinib treatment efficacy. Post hoc analysis of these pooled RA trial data suggests that baricitinib therapy is associated with improved clinical outcomes compared to placebo, regardless of any baseline characteristic categories.

Outcome after 12 Weeks

ACR20 Response, n (%)

DAS28-hsCRP, Change from Baseline LSM (SE)

Patients Achieving SDAI ≤11, n (%)

Placebo (N=716)

Baricitinib 4 mg (N=714)

Placebo (N=716)

Baricitinib 4 mg (N=714)

Placebo (N=716)

Baricitinib 4 mg (N=714)

Age group (years)    <65    ≥65    ≥75

237/603 (39.3%) 49/113 (43.4%) 4/14 (28.6%)

387/578 (67.0%) 92/136 (67.6%) 16/22 (72.7%)

-1.0 (0.06) -1.2 (0.17) 0.2 (0.67)

-2.1 (0.06) -2.4 (0.17) -1.6 (0.59)

102/603 (16.9%) 20/113 (17.7%) 2/14 (14.3%)

221/578 (38.2%) 63/136 (46.3%) 10/22 (45.5%)

Gender    Female    Male

228/571 (39.9%) 58/145 (40.0%)

373/562 (66.4%) 106/152 (69.7%)

-1.0 (0.07) -1.1 (0.14)

-2.1 (0.07) -2.3 (0.14)

97/571 (17.0%) 25/145 (17.2%)

226/562 (40.2%) 58/152 (38.2%)

Ethnicity    Asian    White    Other

70/208 (33.7%) 191/455 (42.0%) 25/52 (48.1%)

130/202 (64.4%) 320/460 (69.6%) 29/51 (56.9%)

-0.5 (0.28) -1.1 (0.07) -0.8 (0.29)

-1.9 (0.29) -2.2 (0.07) -1.5 (0.30)

29/208 (13.9%) 78/455 (17.1%) 15/52 (28.8%)

82/202 (40.6%) 186/460 (40.4%) 16/51 (31.4%)

Serology    RF and ACPA (-)    RF and/or ACPA (+)

29/70 (41.4%) 257/646 (39.8%)

38/71 (53.5%) 441/643 (68.6%)

-1.1 (0.17) -1.1 (0.07)

-1.8 (0.18) -2.3 (0.07)

13/70 (18.6%) 109/646 (16.9%)

17/71 (23.9%) 267/643 (41.5%)

Time from RA diagnosis    <1 year    1-5 years    5-10 years    >10 years

33/105 (31.4%) 108/234 (46.2%) 62/166 (37.3%) 83/210 (39.5%)

73/113 (64.6%) 161/233 (69.1%) 111/166 (66.9%) 133/201 (66.2%)

-0.8 (0.14) -1.2 (0.10) -0.9 (0.14) -1.0 (0.16)

-1.9 (0.13) -2.2 (0.10) -2.3 (0.14) -2.2 (0.16)

12/105 (11.4%) 46/234 (19.7%) 28/166 (16.9%) 36/210 (17.1%)

31/113 (27.4%) 97/233 (41.6%) 79/166 (47.6%) 77/201 (38.3%)

DAS28-hsCRP score    ≤5.1    >5.1

75/210 (35.7%) 211/502 (42.0%)

120/182 (65.9%) 359/530 (67.7%)

-0.7 (0.09) -1.2 (0.07)

-1.8 (0.10) -2.3 (0.07)

58/210 (27.6%) 63/502 (12.5%)

105/182 (57.7%) 177/530 (33.4%)

SDAI    Lowest tertile    Middle tertile    Highest tertile

91/242 (37.6%) 94/240 (39.2%) 99/225 (44.0%)

147/223 (65.9%) 167/246 (67.9%) 161/235 (68.5%)

-0.8 (0.08) -1.0 (0.11) -1.3 (0.12)

-1.9 (0.09) -2.2 (0.10) -2.5 (0.12)

68/242 (28.1%) 33/240 (13.8%) 20/225 (8.9%)

129/223 (57.8%) 92/246 (37.4%) 57/235 (24.3%)

HAQ-DI    Lowest tertile    Middle tertile    Highest tertile

104/250 (41.6%) 99/262 (37.8%) 83/200 (41.5%)

173/256 (67.6%) 157/238 (66.0%) 149/218 (68.3%)

-1.1 (0.10) -0.9 (0.10) -1.2 (0.12)

-2.2 (0.10) -2.2 (0.10) -2.2 (0.12)

64/250 (25.6%) 32/262 (12.2%) 25/200 (12.5%)

130/256 (50.8%) 85/238 (35.7%) 67/218 (30.7%)

Disclosure: J. M. Kremer, Corrona, LLC, 3,Corrona, LLC, 1,AbbVie, Amgen, BMS, Genentech, GSK, Lilly, Medimmune, Pfizer, and Sanofi, 5; M. C. Genovese, AbbVie, Astellas, Eli Lilly and Company,, 2,AbbVie, Astellas, Crescendo Bioscience, Eli Lilly and Company, Galapagos, 5; D. Muram, Eli Lilly and Company, 1,Eli Lilly and Company, 3; J. Zhong, Quintiles, 3; J. Alam, Eli Lilly and Company, 1,Eli Lilly and Company, 3; M. Schiff, None.

To cite this abstract in AMA style:

Kremer JM, Genovese MC, Muram D, Zhong J, Alam J, Schiff M. Effects of Baseline Patient Characteristics on Baricitinib Efficacy in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/effects-of-baseline-patient-characteristics-on-baricitinib-efficacy-in-patients-with-rheumatoid-arthritis/. Accessed .

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