1227 - Sustained Clinical Response with Golimumab Administered Subcutaneously Every 4 Weeks in Ankylosing Spondylitis: 104-Week Results of a Randomized, Placebo-Controlled Study

Monday, November 7, 2011: 9:00 AM-6:00 PM
Hall F2 - Poster Hall (McCormick Place West)
Jürgen Braun1, Desiree van der Heijde2, Atul Deodhar3, Anna Beutler4, Michael Mack4, Benjamin Hsu5 and Robert D. Inman6, 1Rheumazentrum Ruhrgebiet, Herne, Germany, 2Leiden University Medical Center, Leiden, Netherlands, 3Oregon Health & Science University, Portland, OR, 4Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, LLC, Malvern, PA, 5Centocor R&D, a division of J&J Pharmaceutical R& D, LLC/Univ. of Pennsylvania, Malvern/Philadelphia, PA, 6Toronto Western Research Institute, University Health Network and University of Toronto, Toronto, ON
Presentation Number: 1227

Background/Purpose:  The results through wk24 of the GO-RAISE study indicated that golimumab (GLM) significantly improved the signs and symptoms of ankylosing spondylitis (AS) vs. placebo (PBO).   The purpose of this study was to assess the long-term clinical efficacy of GLM over 104 wks in pts with active AS who did and did not exhibit clinical improvement at wk24.

Methods:  Pts (n=356) were randomly assigned (1:1.8:1.8) to subcutaneous injections of PBO, GLM 50 mg, or GLM 100 mg q4wks.  At wk16, pts in the PBO or 50-mg groups with <20% improvement in both total back pain and morning stiffness entered early escape (EE) to GLM 50 or 100 mg, respectively.  At wk24, patients still receiving PBO crossed over (CO) to GLM 50 mg. Among the subgroups of pts defined by clinical efficacy observed at wk24 (Yes vs. No for the individual variables, see Table), the proportions of pts achieving Assessment of SpondyloArthritis International Society (ASAS) partial remission (value < 2 on each of four 0- to 10-cm ASAS domains), AS Disease Activity Score based on C-reactive protein (ASDAS-CRP) remission (score <1.3), ASDAS-CRP major responder (decrease ≥2 from baseline), and ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50) were determined at wk104.   

Results:  After wk24 all pts were receiving GLM 50 or 100 mg. Among pts who demonstrated clinical improvement at wk24, the vast majority maintained their response to GLM through week 104, i.e., 88% of wk24 responders for ASAS partial remission, 91% of pts for ASDAS-CRP remission, 86% of pts for ASDAS-CRP major response, and 89% of pts for BASDAI50 response. No differences in wk104 response were observed among the randomized treatment groups (Table). Among pts who had not achieved clinical improvement at wk24, 22%, 29%, 27% and 44% of pts achieved ASAS partial remission, ASDAS-CRP remission, ASDAS-CRP major response, and BASDAI50 response, respectively at wk104. Among these wk24 nonresponders, the highest wk104 response rates were observed in pts who initially received PBO but EE/CO to GLM at wk16/24 (Table).

Conclusion:  Clinical response that was achieved by patients receiving golimumab through 24wks was sustained through wk104.  In addition 22-35%of patients who had not yet responded well by week 24 to golimumab treatment acquired benefit later in the course of treatment.

Table. Clinical response at wk104 by wk24 response status.

Responder at wk24

PBO

GLM 50&100 mg combined

All patients

ASAS partial remission (n=77)        

88.9% (8/9)

88.2% (60/68)

88.3% (68/77)

ASDAS-CRP remission (n=106)     

93.3% (14/15)

90.1% (82/91)

90.6% (96/106)

ASDAS-CRP major response (n=72)

85.7% (6/7)

86.2% (56/65)

86.1% (62/72)

BASDAI50 response (n=149)           

86.4% (19/22)

89.8% (114/127)

89.3% (133/149)

Nonresponder at wk24

ASAS partial remission (n=208)       

 30.8% (16/52)

 18.6% (29/156)

 21.6% (45/208)

ASDAS-CRP remission (n=158)     

 52.4% (22/42)

 19.8% (23/116)

 28.5% (45/158)

ASDAS-CRP major response (n=203)

 40.4% (21/52)

 21.9% (33/151)

 26.6% (54/203)

BASDAI50 response (n=139)          

 65.9% (27/41)

 34.7% (34/98)

 43.9% (61/139)


Keywords: ankylosing spondylitis (AS)

Disclosure: J. Braun, Johnson & Johnson, 2 ; D. van der Heijde, Johnson & Johnson, 2 ; A. Deodhar, Johnson & Johnson, 2 ; A. Beutler, Johnson & Johnson, 3 ; M. Mack, Johnson & Johnson, 3 ; B. Hsu, Johnson & Johnson, 3 ; R. D. Inman, Johnson & Johnson, 2 .