Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Application of a New Composite Measure of Minimal Disease Activity in Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalysis of the ADEPT Trial
Mease1, Philip, Perdok2, Renee, Kary3, Sonja, Kupper3, Hartmut
TNF antagonists are highly effective in treating patients (pts) with psoriatic arthritis (PsA), usually within 12 weeks.1 Most recently, a new outcome score measuring a minimal disease activity (MDA) state was developed for that incorporates various clinical manifestations of PsA. We performed a post-hoc analysis of MDA achievement in pts with active PsA treated with adalimumab (ADA) or placebo (PBO) in a 24-week randomized controlled trial (ADEPT).2
MDA is defined as achievement of 5 of the 7 following criteria: tender joint count (TJC, 078) <=1, swollen joint count (SJC, 076), Psoriasis Activity and Severity Index (PASI) <=1 or body surface area (BSA) <=3%, pt pain on a visual analog scale (VAS, 0100 mm) <=15, Patient's Global Assessment of disease activity (PaGA; VAS 0100 mm) <=20, Health Assessment Questionnaire (HAQ) <=0.5, and tender entheseal points (no definition of enthesitis scoring methodology, 013) <=1.3 Adults with active PsA (>=3 TJC and >=3 SJC) self-administered ADA 40 mg or PBO every other week for 24 weeks. For calculation of MDA at Weeks 12 and 24, we used the PASI and a heel-limited enthesitis score (04). We alternatively evaluated MDA by 5 of 6 criteria (omitting the enthesitis score). Only pts with PsA and active psoriasis (Ps) (i.e., BSA >=3% affected) were included.
Of the 313 pts with active PsA enrolled in ADEPT, 140 pts had Ps with >=3% BSA affected and data for all other required criteria of the MDA definition (70 pts received PBO and 70 received ADA). Baseline characteristics in ADA/PBO-treated pts were mean age, 50/48 years; female, 41%/44%; median TJC, 21/26; median SJC, 13/12; median PaGA 49/48; median pain, 53/48; median PASI, 5.5/6.4; median HAQ, 1/1.06; and mean enthesitis, 0.8/1. At Week 24, data were available from 61 (87%) PBO- and 65 (93%) ADA-treated pts. At Week 12, 33.3% of ADA- and 3.1% of PBO-treated pts achieved MDA based on 5 of 7 criteria (p<0.001). At Week 24, the percentages were 40.0% (ADA) and 6.5% (PBO) (p<0.001). When using 5 of 6 criteria for MDA, 24.2% and 1.6 % of ADA- and PBO-treated pts achieved MDA at Week 12 (p <0.001) and 32.3% and 1.6% of ADA- and PBO-treated pts achieved MDA ( 5 out of 6) at Week 24 (p<0.001). Fulfillment of individual MDA components are also summarized (table).
Observed Percentages of Pts Who Fulfilled Individual MDA Criteria at Baseline, Week 12, and Week 24
|Baseline||Week 12||Week 24|
|MDA Criterion Fulfilled||ADA (n=70)||PBO (n=70)||ADA (n=66)||PBO (n=64)||ADA (n=65)||PBO (n=61)|
|Enthesitis <=1, %||75||68.6||83.1||64.1||82.8||67.2|
This study demonstrates the application and utility of a new composite measure of MDA in PsA. Approximately one-third of pts with PsA who had both active arthritis and active Ps experienced MDA after 12 and 24 weeks of ADA treatment.
To cite this abstract, please use the following information:
Mease, Philip, Perdok, Renee, Kary, Sonja, Kupper, Hartmut; Application of a New Composite Measure of Minimal Disease Activity in Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalysis of the ADEPT Trial [abstract]. Arthritis Rheum 2009;60 Suppl 10 :537