Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Golimumab, a New, Human, TNF- antibody Administered Subcutaneously Every 4 Weeks, in Ankylosing Spondylitis (AS): 104-Week Efficacy and Safety Results of the Randomized, Placebo-Controlled GO-RAISE Study

Braun1,  J., van der Heijde2,  Désirée M.F.M., Deodhar3,  Atul A., Diekman4,  L., Sieper5,  J., Kim6,  S.I., Beutler7,  A.

Rheumazentrum Ruhrgebiet, Herne, Germany,
Leiden University Medical Center, Leiden, Netherlands,
Oregon Health & Science University, Portland, OR,
University of Texas Medical School, Houston, TX,
Charite Hospital, Berlin, Germany,
Pusan National University Hospital, Busan, South Korea,
Centocor R&D, Inc, Malvern, PA,
University of Toronto, Toronto, ON

Purpose:

To assess golimumab (GLM) efficacy/safety in pts with active ankylosing spondylitis (AS).

Methods:

356 pts were randomized (1.8:1.8:1 ratio) to SC GLM 50 or 100mg or PBO q4wks. Eligible pts had definite AS (modified NY criteria), BASDAI >=4, and a back pain score of >=4. At wk16, PBO or GLM 50 mg pts with <20% improvement in total back pain and morning stiffness entered early escape (EE) to GLM 50 and 100mg q4wks, resp (double-blind). At wk24, pts still receiving PBO crossed over to blinded GLM 50mg SC injections q4wks; others continued regimen through wk100, with evaluation 4 wks later. Key data summaries are based on randomized treatment groups with no statistical comparisons; other summaries show observed data only by regimen followed.

Results:

As reported previously, the primary endpoint (proportion of pts with ASAS20 at wk14), was achieved. Benefit seen at wks 14&24 was maintained through wk104 (Table). BASMI linear scores improved from baseline to wk52; improvements were also maintained through wk104, as were improvements in SF-36 MCS & PCS scores. Pts not responsive to GLM 50mg who increased to 100mg had lower rates of ASAS response and less improvement in other parameters vs other GLM-treated pts (Table). AEs through wk104 were reported for 94% of GLM pts (little variation across GLM doses). Through wk104, 11% of GLM pts had a serious AE; the rate of GLM injection-site reactions was 1.4% (106/7705 inj) through wk104. There were no deaths.

Table.

 PlaceboGLM50mgGLM100mg
Pts randomized78**138140
ASAS 20+30 (38.5%)83 (60.1%)100 (75.6%)
ASAS 40+30 (38.5%)77 (55.8%)76 (54.3%)
ASAS partial remission+17 (21.8%)44 (31.9%)43 (30.7%)
BASDAI++6.02 (1.36, 7.79)2.65 (0.84, 6.08)2.73 (1.08, 5.34)
BASFI++4.93 (0.98, 7.07)2.22 (0.52, 5.80)1.77 (0.49, 4.79)
Table footnotes:
*Intent-to-treat analysis
+n in response, (%)
++median, (interquartile range)
**Includes 35 pts who did not meet EE criteria at wk16 and 41 pts who did

Conclusion:

Clinical improvements in AS pts previously seen at wk24 were maintained through wk104, with no major differences in efficacy/safety between GLM doses. GLM was generally well tolerated through 2yrs of this 5yr study.

To cite this abstract, please use the following information:
Braun, J., van der Heijde, Désirée M.F.M., Deodhar, Atul A., Diekman, L., Sieper, J., Kim, S.I., et al; Golimumab, a New, Human, TNF- antibody Administered Subcutaneously Every 4 Weeks, in Ankylosing Spondylitis (AS): 104-Week Efficacy and Safety Results of the Randomized, Placebo-Controlled GO-RAISE Study [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1259
DOI: 10.1002/art.26333

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