ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 712

Efficacy of Golimumab for Nonradiographic Axial Spondyloarthritis (nr-axSpA): Subgroup Analysis By Baseline MRI and C-Reactive Protein Status

Joachim Sieper1, Désirée van der Heijde2, Walter Maksymowych3, Jürgen Braun4, G Bergman5, Sean P. Curtis6, Anjela Tzontcheva6, George Philip6, Susan Huyck6 and Maxime Dougados7, 1Rheumatology Department, Charité – University Medicine Berlin, Berlin, Germany, 2Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 3Medicine, University of Alberta,, Edmonton, AB, Canada, 4Rheumazentrum Ruhrgebiet, Herne, Germany, 5Merck & Co., Inc., Whitehouse Station, NJ, 6Merck & Co., Inc., Kenilworth, NJ, 7Paris-Descartes University, Paris, France

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ,

Session Information

Date: Sunday, November 13, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster I: Axial and Peripheral Spondyloarthritis – Clinical Aspects, Imaging and Treatment

Session Type: ACR Poster Session A

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

Background/Purpose: Efficacy of golimumab (GLM) for nr-axSpA was demonstrated in a randomized, double-blind (DB), placebo (PBO)-controlled, phase 3 study (GO-AHEAD; NCT01453725).1 In a subgroup analysis, we now investigate the effects of GLM based on presence or absence of objective inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] > upper limit of normal [ULN]) at baseline.

Methods: Patients with nr-axSpA (ASAS criteria, centrally read SI joint X-rays/MRIs, disease duration ≤5 years, chronic back pain ≥3 years, high disease activity, and inadequate response or intolerance to NSAIDs) were randomized (with ASAS-defined MRI sacroiliitis by single central reader [yes, SI+; no, SI–] and CRP level [≤ULN or >ULN] as stratification factors) to GLM 50 mg SC or PBO Q4W for 16 weeks. The primary endpoint was ASAS20 response at week 16. Estimated between-group differences in response at week 16 on ASAS20, ASAS40, BASDAI50, and ASAS partial remission (PR) were compared for four patient subgroups (MRI SI+ & CRP >ULN; MRI SI– & CRP >ULN; MRI SI+ & CRP ≤ULN; MRI SI– & CRP ≤ULN) by Miettinen-Nurminen methods; no multiplicity control was used.

Results: In total, 197 patients were treated (GLM=97; PBO=100). Treatment-group differences in ASAS20, ASAS40, BASDAI50, and ASAS PR response were greater in patients with baseline objective inflammation (Figure). Results should be interpreted with caution, given the small subgroups and absence of multiplicity control.

Conclusion: In the GO-AHEAD trial, responses to GLM (vs PBO) were greater in patients with objective inflammation (particularly with CRP >ULN) at baseline. Reference 1. Sieper J, et al. Arthritis Rheum. 2015;67(10),2702–2712. Figure: Subgroup Analysis of Response by MRI SI Status and CRP Level at Baseline

SUBMISSION INFORMATION Conflict of Interest Disclosures: JS: Consulting: AbbVie, Eli Lilly, Janssen Biologics, Merck, Novartis, Pfizer, Roche, UCB DVH: Consultant: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB, Vertex; employment: Imaging Rheumatology BV MD: Grant/research support: AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB WPM: Grant/research support: AbbVie, Janssen, Pfizer; consultant: AbbVie, Amgen, UCB, Pfizer, Merck, Janssen, Eli Lilly, Celgene, Synarc, Boehringer GB, SPC, GP, AT, SH: Employment, shareholders: Merck & Co., Inc., Kenilworth, NJ, USA JB: Grant/research support: Abbvie (Abbott), Amgen, Biogen, Boehringer, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB; Consulting: Abbvie (Abbott), Amgen, Biogen, Boehringer, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB.  

Disclosure: J. Sieper, Abbott, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 8,Abbott, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 5; D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, 5,Director of Imaging Rheumatology bv, 3; W. Maksymowych, Merck & Co., Inc., 5; J. Braun, Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 5,Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 2; G. Bergman, Merck & Co., Inc., 3; S. P. Curtis, Merck & Co., Inc., 3; A. Tzontcheva, Merck & Co., Inc., 3; G. Philip, Merck & Co., Inc., 3; S. Huyck, Merck & Co., Inc., 3; M. Dougados, AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma, 2,AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma, 5.

To cite this abstract in AMA style:

Sieper J, van der Heijde D, Maksymowych W, Braun J, Bergman G, Curtis SP, Tzontcheva A, Philip G, Huyck S, Dougados M. Efficacy of Golimumab for Nonradiographic Axial Spondyloarthritis (nr-axSpA): Subgroup Analysis By Baseline MRI and C-Reactive Protein Status [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-golimumab-for-nonradiographic-axial-spondyloarthritis-nr-axspa-subgroup-analysis-by-baseline-mri-and-c-reactive-protein-status/. Accessed .

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