ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2567

Clinically Meaningful Improvement in Skin and Nail Psoriasis in Bio-Naïve Active Psoriatic Arthritis Patients Treated with Intravenous Golimumab: Results through Week 24 from a Phase 3 Study

M. Elaine Husni1, Philip J. Mease2, Soumya D Chakravarty3, Shelly Kafka4, Diane D. Harrison5, Dennis Parenti4, Lilianne Kim5, Kim Hung Lo5, Elizabeth C Hsia6 and Arthur Kavanaugh7, 1Cleveland Clinic, Cleveland, OH, 2Swedish Medical Center & U of Wash School of Medicine, Seattle, WA, 3Janssen Scientific Affairs, LLC/Drexel U School of Medicine, Horsham/Phila, PA, 4Janssen Scientific Affairs, LLC, Horsham, PA, 5Janssen Research & Development, LLC, Spring House, PA, 6Janssen Research & Development, LLC/University of Pennsylvania, Spring House/Philadelphia, PA, 7UCSD, San Diego, CA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

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

Background/Purpose: GO-VIBRANT was a Phase 3 trial of intravenous (IV) golimumab (GLM) in adult patients (pts) w/active psoriatic arthritis (PsA). To evaluate improvement in skin, nail psoriasis & Dermatology Life Quality Index (DLQI) w/ IV GLM.

Methods: Adult bio-naïve PsA pts w/ active disease (≥5 swollen & tender joints, CRP ≥0.6mg/dl, active plaque psoriasis or documented history, & despite treatment w/csDMARDs &/or NSAIDs) were randomized to IV GLM 2mg/kg at wks 0, 4, & every 8 wks thereafter or PBO at wks 0, 4, 12, & 20 w/ crossover to GLM at wk24. Pts w/ ≥3% body surface area (BSA) psoriasis at baseline (BL) were assessed using Psoriasis Area and Severity Index (PASI, 0-72) 75/90/100% & modified Nail Psoriasis Severity Index (mNAPSI, 0-130) at BL, wks 14 & 24 (in pts w/ mNAPSI >0 at BL). DLQI was assessed at BL, wks 8, 14 & 24.

Results: 394 pts (PBO: n=198; GLM: n=196) had ≥3% BSA psoriasis at BL; 76.5% had mNAPSI>0 at BL (mean 18.6). Pts on GLM achieved a greater PASI 75 response vs PBO (59.2% vs 13.6%, p<0.001) at wk14 & at wk24 (64.8% vs 13.1%, p<0.001). At wk14, pts on GLM achieved greater PASI 90/100 responses vs PBO (39.3/16.8% vs 6.6/4.5%; p<0.001 for all) & at wk24 (42.9/25.5% vs 7.6/5.6%; p<0.001 for all) (Table 1). At wk14, similar proportions of pts in the GLM groups, regardless of BL MTX use, achieved PASI 90/100 responses. At wk24, greater proportions of pts on GLM + MTX & GLM only achieved PASI 100 vs PBO (+MTX: 30.5% vs 7%, p<0.001; ‑MTX: 15.4% vs 1.8%, p<0.010) (Table 1). The mean decrease (improvement) from BL in the mNAPSI score was greater in GLM vs PBO (−9.6 vs −1.9, p<0.001) at wk14 & at wk24 (−11.4 vs −3.7, p<0.001). At wk8, the mean decrease (improvement) from BL in DLQI was greater in GLM vs PBO (−7.2 vs −1.7, p<0.001), at wk14 (−7.7 vs −1.8, p<0.001) & wk24 (−8.1 vs −1.9, p<0.001). At wk14, 55.1% of pts treated w/ GLM achieved a PASI 50 response & improvement in DLQI ≥5 vs 7.1% treated w/ PBO (p<0.001) & at wk24, 59.2% vs 8.1% (p<0.001).

Conclusion: As early as wk14, IV GLM demonstrated clinically meaningful improvements in skin psoriasis irrespective of MTX use & nail psoriasis. Improvement in DLQI was seen as early as wk8, w/ continued improvement at wks14 & 24.


Table 1. Change from Baseline in PASI 90/100 Through Wk24

 

Wk14

Wk24

PBO

GLM

PBO

GLM

Pts evaluable for improvement fr/ BL in PASI, n

198

196

198

196

PASI 90 (%)

% Diff (95% CI)

6.6

39.3

32.7 (25.10, 40.40)*

7.6

42.9

35.3 (27.52, 43.16)*

PASI 100 (%)

% Diff (95% CI)

4.5

16.8

12.3 (6.34, 18.30)*

5.6

25.5

20.0 (13.22, 26.85)*

+ BL MTX, n

142

131

142

131

PASI 90 (%)

% Diff (95% CI)

7.7

41.2

33.5 (23.97, 42.98)*

9.2

45.8

36.6 (26.88, 46.41)*

PASI 100 (%)

% Diff (95% CI)

5.6

17.6

11.9 (4.39, 19.46)**

7.0

30.5

23.5 (14.55, 32.43)*

– BL MTX, n

56

65

56

65

PASI 90 (%)

% Diff (95% CI)

3.6

35.4

31.8 (19.21, 44.41)*

3.6

36.9

33.4 (20.65, 46.05)*

PASI 100 (%)

% Diff (95% CI)

1.8

15.4

13.6 (4.17, 23.03)***

1.8

15.4

13.6 (4.17, 23.03)***

*p<0.001; **p=0.002; ***p=0.010

Table 2. Change from Baseline in mNAPSI Through Wk24

 

Wk14

Wk24

PBO

GLM

PBO

GLM

Pts (mNAPSI >0) evaluable for change fr/ BL, n

170

197

170

197

Mean (SD)

LS Mean diff (95% CI)

-1.9 (13.05)

 

-9.6 (15.71)

-8.4 (-10.71, -6.05)*

-3.7 (14.45)

 

-11.4 (16.38)

-8.4 (-10.82, -6.01)*

*p<0.001

 

Disclosure: M. E. Husni, Janssen Research & Development, LLC, 2; P. J. Mease, Janssen Research & Development, LLC, 2; S. D. Chakravarty, Janssen Scientific Affairs, LLC, 3; S. Kafka, Janssen Scientific Affairs, LLC, 3; D. D. Harrison, Janssen Research & Development, LLC, 3; D. Parenti, Janssen Scientific Affairs, LLC, 3; L. Kim, Janssen Research & Development, LLC, 3; K. H. Lo, Janssen Research & Development, LLC, 3; E. C. Hsia, Janssen Research & Development, LLC, 2; A. Kavanaugh, Janssen Research & Development, LLC, 2.

To cite this abstract in AMA style:

Husni ME, Mease PJ, Chakravarty SD, Kafka S, Harrison DD, Parenti D, Kim L, Lo KH, Hsia EC, Kavanaugh A. Clinically Meaningful Improvement in Skin and Nail Psoriasis in Bio-Naïve Active Psoriatic Arthritis Patients Treated with Intravenous Golimumab: Results through Week 24 from a Phase 3 Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/clinically-meaningful-improvement-in-skin-and-nail-psoriasis-in-bio-naive-active-psoriatic-arthritis-patients-treated-with-intravenous-golimumab-results-through-week-24-from-a-phase-3-study/. Accessed .

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