Minimal Disease Activity Is a Stable Measure of Therapeutic Response in Psoriatic Arthritis Patients Receiving Treatment with Adalimumab

Frank Behrens¹, Michaela Koehm², Eva Christina Schwaneck³, Marc Schmalzing⁴, Holger Gnann⁵, Gerd Greger⁶, Hans-Peter Tony⁷ and Harald Burkhardt¹, ¹Division of Rheumatology and Fraunhofer IME-Project-Group Translational Medicine and Pharmacology, Goethe University, Frankfurt, Germany, ²Division of Rheumatology and Fraunhofer IME-Project-Group Translational Medicine and Pharmacology, Goethe University, Frankfurt/Main, Germany, ³Rheumatology/Immunology, Medical Clinic II, University Clinic Wuerzburg, Wuerzburg, Germany, ⁴Rheumatology/Clinical Immunology, Medical Clinic II, University Clinic Wuerzburg, Würzburg, Germany, ⁵Abteilung Biostatistik, GKM Gesellschaft für Therapieforschung mbH, München, Germany, ⁶AbbVie Deutschland GmbH & Co.KG, Wiesbaden, Germany, ⁷Rheumatology/Immunology, Medical Clinic II, University Clinic Wuerzburg, Würzburg, Germany

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Adalimumab, Disease Activity, measure and psoriatic arthritis

Session Information

Date: Monday, November 14, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster II: Psoriatic Arthritis

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Minimal disease activity (MDA) is an important goal for patients with rheumatologic disorders, including psoriatic arthritis (PsA). The assessment of MDA could potentially help guide therapeutic modifications as a part of treat-to-target strategies. The availability of data from a large PsA cohort in an observational study of routine clinical care offered a unique possibility to investigate the potential value of MDA as an instrument for guiding treatment decisions during daily clinical practice.

Methods: We analyzed data from a large German multicenter observational study of patients with active PsA who initiated adalimumab (ADA) therapy during routine clinical care. Patients with active disease (Disease Activity Score-28 joints [DAS28] ≥3.2), joint involvement, and adequate MDA data were included in these evaluations. MDA was defined as meeting 5 of 7 criteria as reported by Coates et al. (Ann Rheum Dis2010;69:48-53), with slight modifications to criteria for pain, function, and enthesitis to reflect available data. Patients were followed for up to 24 months.

Results: Of 1684 patients with PsA who initiated ADA, the mean age was 50 years, 51% were female, and the disease duration was 9.5 and 18.1 years for arthritis symptoms and psoriasis, respectively. A total of 597/1684 (35.5%) patients achieved MDA at month 6. This proportion increased slightly during the 24-month study (454/1098 [41.3%] at month 12; 348/764 [45.5%] at month 24), likely due to responder bias. Pain was the most difficult criterion to achieve and the absence of enthesitis was the criterion most likely to be fulfilled (Table 1). Correlation analyses for month 6 data found that PGA ≤2 had the highest correlation with the achievement of MDA (Pearson correlation coefficient=0.72), followed by TJC ≤1 (0.61) and pain ≤1 (0.60), while absence of enthesitis (0.21) and BSA ≤3% (0.31) had the lowest correlations with MDA (P<0.001 for all analyses). Among patients with complete data available for all time points from month 6 to month 24 (n=554), 214 (38.6%) achieved an MDA at month 6. Of the patients who achieved MDA at month 6, 118 of 214 (55.1%) also had an MDA at all subsequent time points (months 9, 12, 18, and 24). Of the patients who did not achieve an MDA at month 6 (n=340), 201 (59.1%) failed to achieve an MDA at any subsequent time point.

MDA Criteria	% of patients (n=1684)
Tender joint count (TJC) ≤1	46.6%
Swollen joint count (SJC) ≤1	70.1%
Body surface area (BSA) ≤3%	64.8%
Patient pain score ≤1 on a 0-10 point scale*	21.1%
Patient global disease activity (PGA) ≤2	40.1%
Funktionsfragebogen Hannover score ≥83% remaining function^†	47.4%
No enthesitis^‡	88.8%
*Published criterion is ≤15 points on a 100 point scale ^†Published criterion is Health Assessment Questionnaire ≤ 0.5 ^‡Published criterion is tender entheseal points ≤ 1

Conclusion: MDA criteria provide a stable assessment of therapeutic response during ADA therapy; most patients who achieved MDA at month 6 experienced sustained MDA, while most patients who did not achieve MDA at month 6 did not reach MDA at any subsequent time point. PGA had the highest correlation with MDA, while enthesitis had the lowest. Our data confirm the relevance of assessing MDA in patients with PsA and indicate that MDA may be useful in guiding therapy in treat-to-target strategies.

Disclosure: F. Behrens, AbbVie Deutschland, Roche, Janssen, 5,Chugai, 8; M. Koehm, Pfizer, Janssen, 2; E. C. Schwaneck, AbbVie, Chugai, Baxalta, Roche, Janssen, 5,Chugai, 2; M. Schmalzing, None; H. Gnann, AbbVie Deutschland, 5; G. Greger, AbbVie Deutschland, 3; H. P. Tony, Abbvie, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Roche, Takeda, UCB, 5,Abbvie, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Roche, Takeda, UCB, 8; H. Burkhardt, AbbVie Deutschland, BMS, Chugai, Janssen, Pfizer, UCB, 5,Pfizer Inc, 2.

To cite this abstract in AMA style:

Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Gnann H, Greger G, Tony HP, Burkhardt H. Minimal Disease Activity Is a Stable Measure of Therapeutic Response in Psoriatic Arthritis Patients Receiving Treatment with Adalimumab [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/minimal-disease-activity-is-a-stable-measure-of-therapeutic-response-in-psoriatic-arthritis-patients-receiving-treatment-with-adalimumab/. Accessed .

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