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Abstract Number: 2218

5 Year Safety, Efficacy, and Radiographic Data in Patients with Active Psoriatic Arthritis Treated with Golimumab: Results From the Long-Term Extension of a Randomized, Placebo-Controlled Study

Arthur Kavanaugh1, Desiree M. van der Heijde2, Iain B. McInnes3, Philip J. Mease4, Gerald G. Krueger5, Dafna D. Gladman6, Yiying Zhou7, J. D. Lu8, Zhenhua Xu9, Lenore Noonan10 and Anna Beutler9, 1UCSD School of Medicine, La Jolla, CA, 2Dept of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 3University of Glasgow, Glasgow, United Kingdom, 4Rheumatology Research, Swedish Medical Center, Seattle, WA, 5School of Medicine, University of Utah, Salt Lake City, UT, 6Division of Rheumatology, Toronto Western Hospital and University of Toronto, Toronto, ON, Canada, 7Biostatistics, Janssen Research & Development, LLC., Spring House, PA, 8Janssen Research & Development, LLC, Spring House, PA, 9Janssen Research & Development, LLC., Spring House, PA, 10Immunology, Janssen Research & Development, LLC., Spring House, PA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Psoriatic arthritis and safety

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Session Information

Session Title: Spondylarthropathies and Psoriatic Arthritis: Clinical Aspects and Treatment

Session Type: Abstract Submissions (ACR)

5 year safety, efficacy, and radiographic data in patients with active psoriatic arthritis treated with golimumab: Results from the long-term extension of the randomized, placebo-controlled, GO-REVEAL study

Background/Purpose: GO-REVEAL is the first study evaluating outcomes of anti-TNF tx in active PsA through 5 years. Safety and efficacy, including radiographic progression in golimumab (GLM) tx’d patients (pts) from the long-term extension of GO-REVEAL is presented. 

Methods: 405 adult PsA pts (≥3 swollen, ≥3 tender joints) were randomized to SC injections of placebo (PBO, Grp1, n=113), GLM50mg (Grp2, n=146), or GLM100mg (Grp3, n=146) q4wks through wk20. Concomitant MTX at baseline was allowed but not required. Starting at wk16, PBO pts with <10% improvement in swollen and tender joints received GLM50mg, remaining PBO pts received GLM50mg starting at wk24; all pts received GLM from wk24 forward. After wk52, pts could change the dose from GLM50 mg to 100mg based on investigator judgment. The last GLM injection was at wk 252. Efficacy was assessed at wk 256 based on randomized grp and completer analyses using ACR response criteria, DAS28-CRP, PASI, HAQ, enthesitis, dactylitis , NAPSI scores, and the PsA-modified Sharp/van der Heijde Score (SHS). Safety evaluations included all pts who received at least one GLM dose through 5 years. 

Results: Of 405 pts randomized, 335 continued in the study at wk104, and 279 pts (69%) continued GLM tx through wk252. 29% of Grp2 pts dose escalated to GLM100mg; 25% of Grp3 pts decreased the dose from 100mg to 50mg. Baseline characteristics of pts who continued in the study at Wk 104 are provided in Table 1. Efficacy results are presented in Table 2. ACR and PASI responses were similar in pts tx’d with or without MTX; changes from baseline in SHS scores were minimal and numerically less in pts tx’d with GLM and MTX compared with GLM alone. Overall, 88%, and 21% GLM tx’d pts experienced AE and SAE, resp. 12% of pts discontinued GLM tx due to AE, and 5% and 4% pts experienced malignancy (including NMSC), and serious infection, resp. Antibodies to golimumab were detected in 6% of pts.

Conclusion: Pt attrition through 5yrs of GLM tx was low. GLM tx resulted in long-term maintenance of clinically meaningful responses in the arthritic and skin components of PsA, improved physical function, and arrest of radiographic progression. No apparent differences between long-term safety and efficacy of 2 GLM doses administered q4wks were observed, however the interpretation of the data is limited due the tx changes allowed across randomized grps.

Table 1. Mean (SD) baseline characteristics

 

Group 1a

 

Group 2b

 

Group 3c

 

No. of  pts continued in the study at wk104

88

118

129

 

 

 

  

DAS28 score

PASI (in pts with ≥3%BSA)

HAQ-DI score (0-3)

5.0(0.1)

7.7(5.7)

1.1 (0.5)

4.9(1.1)

9.4(7.6)

1.0 (0.6)

4.8(1.0)

11.2(9.6)

1.1 (0.6)

Enthesitis score (0-15)

5.1(4.0)

5.6(3.8)

5.8(4.1)

Dactylitis score (0-60)

2.9(2.0)

6.8(6.5)

5.5(6.9)

Total SHS (0-528)

19.4(30.2)

26.2 (36.9)

23.3(36.7) 

 

Table 2. Clinical and radiographic efficacy at wk 256

 

Group 1a

 

Group 2b

 

Group 3c

 

No. of  pts  continued in the study at wk256

77

95

109

Clinical efficacy

 

 

 

ACR20 (% of pts)

77.9%

76.8%

78.0%

ACR50 (% of pts)

49.4%

58.9%

56.9%

ACR70 (% of pts)

36.4%

41.1%

39.4%

DAS28-CR response  (% of pts)

 

91.9%

 

94.5%

 

91.3%

 

Mean (SD) improvement in HAQ-DI

0.5 (0.6)

0.5(0.5)

0.5(0.6)

PASI75 (in pts with ≥3%BSA) (% of pts)

72.7%

68.6%

78.5%

Mean % improvement in enthesitis score

68.3%

73.7%

72.4%

Mean %  improvement in dactylitis score

74.7%

85.8%

72.0%

Mean %  improvement in NAPSI score

79.2%

75.9%

76.5%

 

Radiographic progression

 

 

 

Estimated annual rate of progression at  baseline (mean total SHS/mean PsA disease duration) 

 2.1

3.1

 2.5

Mean  annual rate of  progression (change from baseline in total SHS/5yrs)

Mean (SD) change from baseline in total SHS       

0.06

0.3(3.8)

0.06

0.3 (4.1)

0.01

0.1 (2.7)

a Includes pts randomized to PBO who switched to GLM at wk16 or 24; after wk 52 pts could receive GLM50mg or 100mg.

b Includes pts randomized to GLM50 mg; after wk 52 pts could receive GLM50 mg or 100mg.

c Includes pts randomized to GLM100 mg; after wk 52 pts could receive GLM100mg or 50mg.

 


Disclosure:

A. Kavanaugh,

Janssen Research and Development, LLC,

9;

D. M. van der Heijde,

Janssen Research and Development, LLC,

9;

I. B. McInnes,

Janssen Research and Development, LLC,

;

P. J. Mease,

Janssen Research and Development, LLC,

9;

G. G. Krueger,

Janssen Research and Development, LLC,

9;

D. D. Gladman,

Janssen Research and Development, LLC,

9;

Y. Zhou,

Janssen Research and Development, LLC,

9;

J. D. Lu,

Janssen Research and Development, LLC,

3;

Z. Xu,

Janssen Research and Development, LLC,

3;

L. Noonan,

/janssen Research and Development, LLC,

3;

A. Beutler,

Janssen Research and Development, LLC,

3.

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