ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2554

Abatacept without Methotrexate in Patients with Active Psoriatic Arthritis: A Post Hoc Analysis of a Phase III, Randomized Study

Vibeke Strand1, Thomas Lehman2, Harris A Ahmad2, Alyssa Johnsen2, Sandhya Balachandar2 and Philip J. Mease3, 1Stanford University, Palo Alto, CA, 2Bristol-Myers Squibb, Princeton, NJ, 3Swedish Medical Center and University of Washington School of Medicine, Seattle, WA

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: In the randomized, placebo (pbo)-controlled Phase III ASTRAEA study (ClinicalTrials.gov, NCT01860976) patients (pts) with active psoriatic arthritis (PsA) were randomized to abatacept (ABA) or pbo; ABA significantly improved ACR20 responses at 24 weeks (wks).1 MTX was permitted but not required; randomization was by concurrent MTX resulting in a subgroup of pts receiving ABA or pbo without MTX. This post hoc analysis evaluates the efficacy of ABA in pts not receiving MTX. Methods: Pts with PsA and inadequate response/intolerance to conventional synthetic (cs)DMARDs were randomized (1:1) to SC ABA 125 mg or pbo weekly for 24 wks. At Wk 16, pts without ≥20% improvement in joint counts escaped to open-label ABA.1 MTX, other csDMARDs and corticosteroids (≤10 mg prednisone equivalent) at enrollment could be continued at a stable dose. Baseline pt characteristics were analyzed descriptively by concomitant MTX use. Outcomes including ACR20 responses (95% CI) and adjusted mean changes in DAS28 (CRP) from baseline were evaluated in pts not receiving MTX. Results: Of 424 randomized pts, 168 were not receiving concomitant MTX (ABA [n=84], pbo [n=84]). Pts not receiving MTX vs pts receiving MTX were more likely to be from N America, less likely to be from S America, had longer disease duration, and higher rates of TNF inhibitor or experience with ≥2 prior csDMARDs (Table 1). In pts not receiving MTX, the percentage of female pts and baseline structural damage were greater in the ABA vs pbo group. At Wk 24, ABA without MTX significantly increased ACR20 responses (95% CI) vs pbo (32.1% [22.2, 42.1] vs 11.9% [5.0, 18.8]; Figure 1) and improved adjusted mean changes in DAS28 (CRP) from baseline to Wk 24 (95% CI) vs pbo (−1.49 [–1.87, –1.12] vs −0.68 [–1.11, –0.26]; adjusted difference –0.81 [–1.34, –0.28]; Figure 2).

Conclusion: In this post hoc analysis of ASTRAEA, abatacept without MTX significantly improved ACR20 responses and DAS28 (CRP) in pts with PsA. Improvements in outcomes in the pbo group help characterize the true pbo response and the variable nature of PsA symptoms. These data suggest that abatacept without MTX may be successfully used in pts with PsA and inadequate response/intolerance to MTX.

Reference: 1. Mease PJ, et al. Ann Rheum Dis 2017;76:1550–8. Medical writing assistance provided by Katerina Kumpan, PhD (Caudex), funded by Bristol-Myers Squibb.  
 

Table 1. Selected Baseline Demographic and Clinical Characteristics at Baseline by Concomitant MTX
Characteristic With MTX Without MTX*
Abatacept
(n=129) 		Placebo
(n=127) 		Abatacept
(n=84) 		Placebo
(n=84)
Region        
North America
South America 		22 (17.1)
63 (48.8) 		13 (10.2)
58 (45.7) 		22 (26.2)
32 (38.1) 		27 (32.1)
22 (26.2)
Female 65 (50.4) 65 (51.2) 56 (66.7) 47 (56.0)
Disease duration, mean (SD), years 7.5 (7.8) 8.6 (8.2) 9.4 (8.5) 9.1 (8.5)
mTSS, mean (SD) 18.0 (43.5) 22.3 (44.3) 28.5 (54.7) 16.2 (36.9)
Joint space narrowing score, mean (SD) 7.1 (18.3) 10.1 (21.8) 12.7 (25.9) 7.4 (19.1)
Erosion score, mean (SD) 10.9 (25.6) 12.2 (23.4) 15.8 (29.3) 8.9 (19.0)
Pt assessment of pain (VAS), mean (SD) 61.7 (23.6) 64.7 (20.6) 67.9 (23.1) 63.9 (23.6)
Prior csDMARDs 129 (100) 127 (100) 81 (96.4) 80 (95.2)
1
2
≥3 		99 (76.7)
24 (18.6)
6 (4.7) 		100 (78.7)
19 (15.0)
8 (6.3) 		42 (50.0)
34 (40.5)
5 (6.0) 		50 (59.5)
21 (25.0)
9 (10.7)
Prior TNFi 71 (55.0) 69 (54.3) 58 (69.0) 61 (72.6)
Data are n (%) unless specified otherwise Data in bold are overall *Other csDMARDs and corticosteroids at a stable dose were permitted csDMARD=conventional synthetic DMARD; pt=patient; mTSS, modified Total Sharp Score; TNFi=TNF inhibitor; VAS=Visual Analog Score (0–100 mm)



Disclosure: V. Strand, AbbVie, Amgen Corporation, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Celltrion, Corrona, Crescendo/Myriad, EMD Serono, Genentech/Roche, Janssen, Lilly, Merck, Novartis, Pfizer, Samsung, Sandoz, UCB, 5; T. Lehman, Bristol-Myers Squibb, 1, 3; H. A. Ahmad, Bristol-Myers Squibb, 1, 3; A. Johnsen, Bristol-Myers Squibb, 1, 3; S. Balachandar, Rutgers, The State University of New Jersey, 3,Bristol-Myers Squibb, 5; P. J. Mease, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2,AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, Zynerba, 5,AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, UCB, 8.

To cite this abstract in AMA style:

Strand V, Lehman T, Ahmad HA, Johnsen A, Balachandar S, Mease PJ. Abatacept without Methotrexate in Patients with Active Psoriatic Arthritis: A Post Hoc Analysis of a Phase III, Randomized Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/abatacept-without-methotrexate-in-patients-with-active-psoriatic-arthritis-a-post-hoc-analysis-of-a-phase-iii-randomized-study/. Accessed .

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