Comparison of disease activity index for psoriatic arthritis (DAPSA) and minimal disease activity (MDA) targets for patients with psoriatic arthritis: A post hoc analysis of data from phase 3 tofacitinib studies.

To compare achievement of Disease Activity Index in Psoriatic Arthritis (DAPSA) remission (REM)/low disease activity (LDA) with very low disease activity (VLDA)/minimal disease activity (MDA) targets in tofacitinib-treated patients with psoriatic arthritis (PsA). In this post hoc analysis, data were pooled from two phase 3 studies (6 months' [NCT01882439] and 12 months' [NCT01877668] duration) of patients with PsA receiving tofacitinib 5 or 10 mg twice daily. Cut-offs for DAPSA targets: ≤4 for clinical REM and >4-≤14 for LDA. VLDA and MDA were defined as meeting 7 or ≥5, respectively, of 7 criteria. An ordered logistic regression model was performed to evaluate associations between baseline characteristics and achievement of DAPSA targets as well as VLDA/MDA at month 3. Agreement between achieving DAPSA and VLDA/MDA targets at months 1-6 was assessed via kappa tests. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) scores (month 6), modified Total Sharp Score (mTSS) and proportion of radiographic non-progressors (mTSS ≤0.5) at month 12 (NCT01877668 only) were compared across DAPSA and VLDA/MDA targets. Increased disease activity at baseline was associated with reduced likelihood of achieving DAPSA-REM/DAPSA-LDA or VLDA/MDA at month 3. There was moderate agreement (kappa values 0.41-0.60) between DAPSA-REM and VLDA, and DAPSA-LDA and MDA, from months 1 to 6, although over half of patients achieving DAPSA-REM and over two thirds of patients achieving DAPSA-LDA, respectively, were not captured by VLDA and MDA. Achieving DAPSA-REM/DAPSA-LDA or VLDA/MDA was associated with improved HAQ-DI and SF-36 PCS scores at month 6, and slightly reduced radiographic progression at month 12. This analysis of data from tofacitinib-treated patients with PsA demonstrated moderate agreement between the DAPSA and VLDA/MDA composite instruments. In agreement with previous studies, VLDA and MDA may be more difficult to achieve than DAPSA-REM and DAPSA-LDA, respectively. However, the clinical and prognostic relevance of this finding should be determined. These data support DAPSA and VLDA/MDA as useful tools for evaluating disease activity and treatment response in PsA. GOV: NCT01882439; NCT01877668.

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Declaration of Competing Interest EES has received grants/contracts from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Genzyme, Janssen, Novartis and Pfizer Inc (to institution); has received consulting fees from AbbVie, Eli Lilly and Janssen; and has received other remuneration from AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis and Pfizer Inc. GC has received grants/contracts from Pfizer Inc (to institution); has received consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Pfizer Inc and Sandoz; and has received other remuneration from AbbVie, Amgen, Bristol-Myers Squibb, Janssen and Pfizer Inc. PN has received consulting fees and other remuneration from AbbVie, Bristol-Myers Squibb, Eli Lilly, Gilead/Galapagos, Janssen, Novartis, Pfizer Inc and UCB. JSS has received grants/contracts from AbbVie, Astro, AstraZeneca, Eli Lilly, Janssen, Merck Sharpe & Dohme, Pfizer Inc and Roche (to institution); and has received consulting fees and other remuneration from AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO Pharma, Janssen, Merck Sharpe & Dohme, Novartis-Sandoz, Pfizer Inc, R-Pharm, Roche, Samsung, Sanofi and UCB. PJM has received grants/contracts from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun and UCB; has received consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, Sun and UCB; and has received other remuneration from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB. ERS has received grants or contracts from AbbVie and Janssen; and has received consulting fees and other remuneration from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sandoz and UCB. CH, RM and DPdeL are employees and stockholders of Pfizer Inc. AES was an employee of Syneos Health, who were paid contractors to Pfizer Inc in the development of this manuscript.