ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2876

Baseline Demographic and Disease Characteristics Associated with Response to Golimumab in Patients with Active Nonradiographic Axial Spondyloarthritis

Maxime Dougados1, Gina Bergman2, Walter Maksymowych3, Sean P. Curtis2, Susan Huyck2, Anjela Tzontcheva2 and Joachim Sieper4, 1Paris-Descartes University, Paris, France, 2Merck & Co., Inc., Kenilworth, NJ, 3University of Alberta, Edmonton, AB, Canada, 4University Clinic Benjamin Franklin, Berlin, Germany

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , , ,

Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

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

Background/Purpose:  Subgroup analyses can be used to investigate the size and direction of treatment effects across a range of demographic and disease characteristics. The purpose of this study was to explore response consistency in subgroups of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who received golimumab (GLM) or placebo for 16 wks.

Methods: GO-AHEAD was a double-blind, randomized, placebo (PBO)-controlled trial of GLM in patients with active nr-axSpA (ASAS criteria and centrally read sacroiliac (SI) joint X-rays and MRIs; disease duration ≤5 years; chronic back pain; high disease activity [total back pain ≥40 mm on a 0–100 mm Visual Analogue Scale and BASDAI ≥4 cm]; and inadequate response/intolerance to NSAIDs). Patients were randomized 1:1 to subcutaneous GLM 50 mg or PBO every 4 wks. Estimated between-group treatment differences and 95% CIs for ASAS 20 and ASAS 40 response at wk 16 were calculated for prespecified patient subgroups. Treatment and subgroup differences were compared by stratified Miettinen–Nurminen methods with baseline inflammation by SI joint MRI and screening C-reactive protein (CRP) level as stratification factors. No multiplicity control was applied.

Results:  A total of 197 patients were treated (GLM=97; PBO=100). Overall, ASAS 20 at wk 16 was achieved by 71.1% of GLM patients and 40.0% of PBO patients (P <.0001). Although size of response differed somewhat across the subgroups, responses were greater to GLM than PBO in most patient subgroups (P<.05; Table). Because of the small numbers of patients within subgroups and because subgroups may not represent randomized samples, results should be considered exploratory and interpreted with caution. Treatment group differences appeared to be larger in patients with objective signs of inflammation (MRI SI or CRP>ULN). The results for ASAS 40 were very similar to those for ASAS 20.

Table. ASAS 20 Attainment at Week 16 by Treatment Group and Baseline Characteristics

Subgroup

GLM

n/N (%)

PBO

n/N (%)

Difference vs PBOa

% (95% CI)

Gender

 

 

 

  Female

21/36 (58.3)

20/48 (41.7)

14.8 (–6.9, 35.4)

  Male

48/61 (78.7)

20/52 (38.5)

40.0 (21.8, 55.6)

Age

 

 

 

  ≤30 years

41/56 (73.2)

16/45 (35.6)

39.6 (20.4, 56.0)

  >30 years

28/41 (68.3)

24/55 (43.6)

26.1 (5.6, 43.7)

Disease duration

 

 

 

  >median

38/48 (79.2)

18/51 (35.3)

43.3 (24.1, 59.3)

  ≤median

31/49 (63.3)

22/49 (44.9)

18.2 (–1.4, 36.3)

HLA-B27

 

 

 

  Negative

8/16 (50.0)

7/18 (38.9)

11.1 (–23.3, 43.5)

  Positive

61/81 (75.3)

33/82 (40.2)

35.0 (20.2, 48.2)

MRI sacroiliitis

 

 

 

  Yes

48/65 (73.8)

25/66 (37.9)

36.0 (19.3, 50.7)

  No

21/32 (65.6)

15/34 (44.1)

21.6 (–2.6, 43.0)

CRP

 

 

 

  ≤ULN

35/58 (60.3)

25/59 (42.4)

17.9 (–0.3, 35.0)

  >ULN

34/39 (87.2)

15/41 (36.6)

50.6 (30.5, 66.6)

MRI sacroiliitis (+) or CRP >ULN

60/78 (76.9)

30/80 (37.5)

39.6 (24.6, 52.6)

MRI sacroiliitis (–) and CRP ≤ULN

9/19 (47.4)

10/20 (50.0)

–2.6 (–32.7, 27.9)

aDifferences derived from the statistical model.

Conclusion:  Overall, patients with active nr-axSpA who received GLM were more likely to achieve ASAS 20 at wk 16 than those treated with PBO across a variety of baseline characteristics, including those with baseline objective signs of inflammation (eg, MRI SI or CRP >ULN).

Disclosure: M. Dougados, AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, 2; G. Bergman, Merck & Co., Inc., Kenilworth, NJ, USA, 3,Merck & Co., Inc., Kenilworth, NJ, USA, 1; W. Maksymowych, AbbVie, Janssen, Pfizer, 2,AbbVie, UCB, Pfizer, Merck, Janssen, Eli Lilly, Celgene, Synarc, 5; S. P. Curtis, Merck & Co., Inc., Kenilworth, NJ, USA, 3,Merck & Co., Inc., Kenilworth, NJ, USA, 1; S. Huyck, Merck & Co., Inc., Kenilworth, NJ, USA, 3,Merck & Co., Inc., Kenilworth, NJ, USA, 1; A. Tzontcheva, Merck & Co., Inc., Kenilworth, NJ, USA, 3,Merck & Co., Inc., Kenilworth, NJ, USA, 1; J. Sieper, AbbVie, Eli Lilly, Janssen Biologics, Merck, Novartis, Pfizer, Roche, UCB, 5.

To cite this abstract in AMA style:

Dougados M, Bergman G, Maksymowych W, Curtis SP, Huyck S, Tzontcheva A, Sieper J. Baseline Demographic and Disease Characteristics Associated with Response to Golimumab in Patients with Active Nonradiographic Axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/baseline-demographic-and-disease-characteristics-associated-with-response-to-golimumab-in-patients-with-active-nonradiographic-axial-spondyloarthritis/. Accessed .

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/baseline-demographic-and-disease-characteristics-associated-with-response-to-golimumab-in-patients-with-active-nonradiographic-axial-spondyloarthritis/