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Abstract
Background Various instruments are currently used for disease activity and outcome assessment in psoriatic arthritis (PsA). Some measures attempt to incorporate the total spectrum of psoriatic disease manifestations [eg, minimal disease activity (MDA)] while others focus on arthritis assessments [eg, disease activity index for PsA (DAPSA)]. Whether in patients (pts) with PsA it is sufficient to primarily consider joint disease aspects remains unclear.
Objectives To compare DAPSA remission and low disease activity (LDA) with MDA and very low disease activity (VLDA) for the presence of residual abnormalities of the respective composing variables.
Methods This post hoc analysis included pts with PsA receiving adalimumab (ADA) in one of two multicenter studies: ADEPT was a 24-week (wk), randomized, double-blind, placebo-controlled trial; ACCLAIM was a 12-wk, open-label study conducted in Canada in care settings that reflected usual practice. Frequencies of DAPSA remission/LDA and MDA/VLDA were summarized, and the individual PsA manifestations within these states were assessed. DAPSA was summed from the following continuous variables: swollen (66) and tender (68) joints, pt global assessment (PtGA, cm), pt pain (PP, cm), and C-reactive protein (CRP, mg/dL). DAPSA remission was defined as ≤4 and DAPSA LDA as >4 and ≤14. MDA criteria were as follows: ≤1 tender, ≤1 swollen joint, ≤1 entheseal point, PP ≤15mm, PtGA ≤20mm, HAQ ≤0.5, and PASI ≤3. MDA was calculated as fulfilling 5 of the 7 criteria, and VLDA calculated as fulfilling all 7 criteria. Data were as observed.
Results Among 151 pts receiving ADA in ADEPT, 33 (22%) each achieved DAPSA remission and LDA at wk 24, and 20 (14%) and 11 (7%) achieved MDA and VLDA, respectively. Pts achieving DAPSA LDA appeared to mirror those in MDA, with the exception of experiencing numerically higher PP, PtGA, and PASI scores at wk 24 (Table). Pts in DAPSA LDA did experience numerically lower SJC when compared with the MDA achievers, and, like MDA achievers, displayed little residual enthesitis. Only VLDA, but not MDA, could match the stringency of DAPSA remission, a finding that was confirmed through analysis of the ACCLAIM cohort. However, VLDA allowed for numerically higher residual PP and PtGA levels when compared with DAPSA remission. Importantly, residual enthesitis did not differ among pts achieving DAPSA remission or VLDA. Irrespective of disease activity assessment, pts receiving ADA displayed little to no radiographic progression.
Conclusions In the ADEPT and ACCLAIM cohorts, pts who achieved DAPSA remission or VLDA demonstrated similar outcomes with respect to the individual components of both scores, despite the omission of several of these within the DAPSA. Given the DAPSA's continuous nature, its use may offer a good alternative to fulfillment of the VLDA criteria, but these results require confirmation in different pt populations.
Acknowledgements AbbVie: study sponsor, contributed to design, data collection, analysis, interpretation, and abstract writing, review, and approval. Medical writing: Ben Wolfe of AbbVie.
Disclosure of Interest J. Smolen Grant/research support from: AbbVie, Inc., Consultant for: AbbVie, Inc., D. Aletaha Grant/research support from: AbbVie, Inc., Pfizer, Grünenthal, Merck, Medac, UCB, Mitsubishi/Tanabe, Janssen, and Roche, Consultant for: AbbVie, Inc., Pfizer, Grünenthal, Merck, Medac, UCB, Mitsubishi/Tanabe, Janssen, and Roche, D. Gladman Grant/research support from: AbbVie, Inc., Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Pfizer, Novartis, and UCB, Y. Zhang Shareholder of: AbbVie, Inc., Employee of: AbbVie, Inc., F. Ganz Shareholder of: AbbVie, Inc., Employee of: AbbVie, Inc.