Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Adalimumab (ADA) is indicated for the treatment of psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Patients (pts) with peripheral spondyloarthritis (SpA) not previously diagnosed with psoriasis or PsA (non-PsA), presenting primarily with arthritis, enthesitis and/or dactylitis, may also benefit from anti-TNF therapy. ABILITY-2, the first randomized controlled trial to use the ASAS peripheral SpA criteria1 to classify pts for study entry, evaluated the efficacy and safety of ADA in pts with active non-PsA peripheral SpA.
Methods: ABILITY-2 is an ongoing, multicenter phase 3 study. Eligible pts were age ≥18 yrs, fulfilled ASAS peripheral SpA criteria, did not have a diagnosis of psoriasis, PsA, or AS, and had inadequate response or intolerance to NSAIDs. Pts were randomized 1:1 to ADA 40 mg every other wk or placebo (PBO) for 12 wks followed by a 144-wk open-label extension. Primary endpoint was the proportion of pts achieving peripheral SpA response criteria (PSpARC 40) at wk 12: ≥40% improvement (≥20 mm absolute improvement in VAS) from baseline (BL) in Pt’s Global Assessment of Disease Activity (PGA) and of pain (PGA-pain) and ≥40% improvement in ≥1 of the following: swollen joint count (SJC) and tender joint count (TJC); Enthesitis Count, or Dactylitis Count. Other outcomes analyzed included Physician’s Global Assessment (PhGA), BASDAI, enthesitis indices, PSpARC 20/50/70 responses, HAQ-S, and SF-36v2. Adverse events (AE) were collected throughout the study.
Results: 165 pts (ADA 84/PBO 81) were randomized. BL demographics/disease characteristics were similar between groups, except for mean age and % pts with dactylitis count>0. BL characteristics include (ADA/PBO): 57/52% female, 67/56% HLA-B27+, mean TJC 13.0/13.6, mean SJC 6.1/7.3, mean enthesitis count 6.7/7.3, and dactylitis count 0.4/0.7. At Wk 12, the % of ADA pts achieving PSpARC 40 was higher vs. PBO (P=0.006) (table), primarily due to the proportion of patients meeting the PGA, PGA-pain, and TJC/SJC components. Overall, improvement based on other outcomes was greater with ADA vs. PBO. AE incidence rates were similar [ADA/PBO (%)]: any AEs (54.8/54.3), serious AEs (1.2/1.2), and infectious AEs (21.4/28.4); there were no serious infections, TB, or malignancies during the double-blind period.
Conclusion: Adalimumab significantly improved signs, symptoms, and physical function of pts with active non-PsA peripheral SpA and was well-tolerated. ABILITY-2 results suggest that ADA may be an effective treatment option for non-PsA peripheral SpA pts with inadequate response or intolerance to NSAIDs. Further, these results suggest that the PSpARC assessment instrument, pioneered in this study to evaluate this patient population, is a responsive and discriminative outcome measure.
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Table. Week 12 Efficacy Outcomes |
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ADA N=84 |
PBO N=81 |
P valuea |
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Primary endpointb PSpARC 40, % |
39.3 |
19.8 |
0.006 |
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Proportion of patients achieving improvement in each PSpARC 40 componentc (≥40% improvement, plus ≥20 mm improvement in PGA and PGA-pain VAS) |
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PGA, % |
54.3 |
28.8 |
<0.001 |
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PGA pain, % |
53.7 |
31.3 |
0.004 |
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TJC/SJC, % |
57.3 |
29.6 |
<0.001 |
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Enthesitis, % |
51.2 |
42.0 |
0.237 |
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Dactylitis, % |
13.6 |
18.5 |
0.392 |
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Other efficacy endpoints |
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PSpARC 20b, % |
56.0 |
37.0 |
0.015 |
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PSpARC 50b, % |
34.5 |
11.1 |
<0.001 |
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PSpARC 70b, % |
22.6 |
3.7 |
<0.001 |
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PGAd (VAS 0–100), mm |
-27.5 |
-16.4 |
0.003 |
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PGA-paind (VAS 0–100), mm |
-28.9 |
-17.1 |
0.001 |
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PhGAd (VAS 0–100), mm |
-32.2 |
-18.2 |
<0.001 |
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BASDAId |
-2.1 |
-1.0 |
0.003 |
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TJCd (0–78) |
-5.9 |
-1.8 |
<0.001 |
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SJCd (0–76) |
-3.6 |
-3.1 |
0.045 |
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Leeds enthesitis indexd (0–6) |
-0.8 |
-0.1 |
<0.001 |
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SPARCC enthesitis indexd (0–16) |
-1.7 |
-0.7 |
<0.001 |
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Dactylitis countd (0–20) |
-0.2 |
-0.3 |
0.808 |
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SF-36v2 PCSe |
6.7 |
2.4 |
<0.001 |
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HAQ-S scored |
-0.3 |
-0.2 |
0.051 |
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Values are mean change unless otherwise indicated; Ns may vary by outcome. aADA vs. PBO; bNRI; cObserved analysis; dLOCF; eObserved data (N=83/79, ADA/PBO). ADA, adalimumab; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; HAQ-S, Health Assessment Questionnaire modified for spondyloarthropathies; PBO, placebo; PGA, patient’s global assessment of disease activity; PGA-pain, patient’s global assessment of pain; PhGA, physician’s global assessment; PSpARC, peripheral spondyloarthritis response criteria; PSpARC 20, ≥20% (≥10 mm in VAS) improvement; PSpARC 50, ≥ 50% (≥20 mm in VAS) improvement; PSpARC 70, ≥70% (≥30 mm in VAS) improvement; SF-36v2 PCS, short form-36 health status survey version 2 physical component summary; SJC, swollen joint count; SPARCC, Spondyloarthritis Research Consortium of Canada; TJC, tender joint count. |
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Reference
1. Rudwaleit M et al. Ann Rheum Dis 2011;70:25–31.
Disclosure:
P. J. Mease,
Abbott, Amgen, BiogenIdec, Bristol Myers, Celgene, Genentech, Janssen, Lilly,Merck, Novartis, Pfizer, and UCB,
2,
Abbott, Amgen, BiogenIdec, Bristol Myers, Celgene, Genentech, Janssen, Lilly,Merck, Novartis, Pfizer, and UCB,
5;
J. Sieper,
Abbott, Merck, Pfizer, and UCB,
2,
Abbott, Merck, Pfizer, and UCB,
5,
Abbott, Merck, Pfizer, and UCB,
8;
F. Van den Bosch,
Abbott, Merck, Pfizer, and UCB,
5,
Abbott, Merck, Pfizer, and UCB,
8;
P. Rahman,
Janssen, Schering,
2,
Abbott, Amgen, Janssen, Roche, Schering,
5,
Abbott, Amgen, Janssen, Schering, Bristol-Myers Squibb,
8;
K. Obermeyer,
Abbott Laboratories,
1,
Abbott Laboratories,
3;
A. L. Pangan,
Abbott Laboratories,
3,
Abbott Laboratories,
1.
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