Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
Axial spondyloarthritis (axSpA), including ankylosing spondylitis and nonradiographic axial SpA (nr-axSpA), is a chronic inflammatory disease marked by back pain and progressive spinal stiffness. The goal of GO-AHEAD was to determine if golimumab (GLM) is superior to placebo (PBO) in patients with nr-axSpA.
Methods
GO-AHEAD was a Phase 3b, double-blind, randomized, PBO-controlled trial that evaluated subcutaneous (SC) GLM 50 mg vs PBO in patients aged 18–45 years with active nr-axSpA (Assessment of SpondyloArthritis international Society [ASAS] criteria and centrally-read SI joint X-rays; disease duration ≤5 years; chronic back pain; high disease activity [total back pain ≥40 mm on a 0–100 mm VAS and Bath Ankylosing Spondylitis Disease Activity Index {BASDAI} ≥4 cm]; and inadequate response or intolerance to NSAIDs). Patients were randomized 1:1 to GLM or PBO SC injections every 4 weeks. The primary endpoint was ASAS 20 attainment at week 16. Key secondary endpoints were ASAS 40, ASAS partial remission, and BASDAI 50 attainment; and Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) sacroiliac (SI) joint score change. AS Disease Activity Score based on C-reactive protein (ASDAS) was assessed. Treatment group differences for all patients-as-treated and the target populations (signs of inflammation by MRI or elevated CRP at baseline) were compared using the stratified Miettinen and Nurminen method for responder endpoints and the Mann-Whitney test for MRI SI joint score.
Results
Of 198 patients enrolled, 197 were treated (GLM=97; PBO=100). Mean age was 31 years; 57% were male. At baseline, mean BASDAI was 6.5 cm (SD=1.5), SPARCC MRI SI was 11.3 (SD=14.0), and ASDAS was 3.5 (SD=0.9). The primary endpoint was achieved by significantly more GLM patients (71.1%) than PBO patients (40.0%; table). Significantly more GLM patients also attained ASAS 40, ASAS partial remission, and BASDAI 50 (table). Mean ASDAS improvements were greater with GLM than PBO (−1.7 vs −0.6, respectively; P <.0001). Mean SPARCC MRI SI joint score improvements from baseline to week 16 were greater with GLM than PBO (−5.3 vs −0.9, respectively; P <.0001); improvements for the target population were −6.4 vs −1.2, respectively (P<.0001).
Table. Primary and Key Secondary Outcomes, Week 16
|
|
All Patients as Treated |
Target Population |
|||||
|
|
GLM N=97 n (%) |
PBO N=100 n (%) |
Difference vs PBO,* % (95% CI) |
GLM N=78 n (%) |
PBO N=80 n (%) |
Difference vs PBO,* % (95% CI) |
|
|
ASAS 20 |
69 (71.1) |
40 (40.0) |
31.2 (17.5, 43.6) P <.0001 |
60 (76.9) |
30 (37.5) |
39.6 (24.6, 52.6) P <.0001 |
|
|
ASAS 40 |
55 (56.7) |
23 (23.0) |
33.8 (20.4, 46.1) P <.0001 |
47 (60.3) |
18 (22.5) |
37.9 (23.0, 51.2) P <.0001 |
|
|
ASAS Partial Remission |
32 (33.0)
|
18 (18.0) |
15.2 (3.2, 27.1) P =.0136 |
27 (34.6) |
15 (18.8) |
16.1 (2.5, 29.6) P =.0204 |
|
|
BASDAI 50 |
56 (57.7) |
30 (30.0) |
28.0 (14.4, 40.6) P <.0001 |
46 (59.0) |
23 (28.8) |
30.5 (15.4, 44.3) P <.0001 |
|
|
*Differences derived from the statistical model. |
|
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Adverse events (AEs) occurred in 41% of GLM and 47% of PBO patients. Serious AEs occurred in 1 GLM (female partner reported fetal death) and 2 PBO patients (cholelithiasis, back pain). There were no serious infections, serious opportunistic infections, active tuberculosis, malignancies, serious systemic hypersensitivity, or deaths.
Conclusion
Patients with active nr-axSpA treated with GLM had significantly greater improvements in disease activity and inflammation on MRI than patients treated with PBO. GLM was well-tolerated and generally had a favorable benefit-risk profile.
Disclosure:
J. Sieper,
AbbVie, Eli-Lilly, Janssen Biologics, Merck, Novartis, Pfizer, Roche, and UCB,
5;
D. van der Heijde,
AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex,
5;
M. Dougados,
AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, and UCB,
2;
W. P. Maksymowych,
AbbVie, Janssen, and Pfizer,
2,
AbbVie, UCB, Pfizer, Merck, Janssen, Eli Lilly, Celgene, and Synarc,
5;
J. Boice,
Merck & Co., Inc.,
3;
G. Bergman,
Merck & Co., Inc.,
3;
S. Curtis,
Merck & Co., Inc.,
3;
A. Tzontcheva,
Merck & Co., Inc.,
3;
S. Huyck,
Merck & Co., Inc.,
3;
H. Weng,
Merck & Co., Inc.,
3.
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