Background Patients (pt) with Rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a Patient Support Program (PSP) with variety of services. To date, no prospective study has been conducted to analyze the acceptance and the impact of these PSPs on treatment effectiveness and pt satisfaction.
Objectives The purpose of this study was to examine the effectiveness of ADA on rheumatoid arthritis (RA) treatment course in the context of PSP participation.
Methods PASSION (NCT01383421) was a 78-week (wk) post-marketing observational study of pts with RA receiving ADA in routine clinical care. Pts from the EU, Israel, Mexico, Puerto Rico, and Australia with an insufficient response to ≥1 disease-modifying antirheumatic drug (DMARD) newly initiating ADA (1 prior biologic DMARD was allowed) were enrolled. The primary endpoint was the % of pts achieving the minimal clinically important difference (MCID; improvement of ≥0.22 compared to baseline [BL]) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at wk 78. Non-responder imputation (NRI) was used to account for the missing values. Secondary clinical parameters included % of pts achieving MCID in HAQ-DI at wks 24 and 52 and changes in the 28-joint DAS based on CRP (DAS28(CRP)), Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) at wks 24, 52, and 78 vs BL. Pts were categorized based on their participation in the PSP: ever (PSP users) vs never (PSP non-users) and outcomes were compared after adjusting for corresponding BL values.
Results Overall, the primary endpoint, percentage of pts achieving the MCID for HAQ-DI, was achieved by 72.1% (as observed) and 42.8% (NRI) of pts at week 78 with the percentage of pts achieving the MCID for HAQ-DI significantly higher in PSP users vs PSP non-users (48.1% vs 37.8% [NRI]; P<0.001). From 1,025 pts, 48.7% pts were PSP users (BL: mean age, 54.3 years (y); % female, 77.1%; mean RA duration, 7.8 y; mean HAQ-DI, 1.5; mean DAS28(CRP), 5.3; mean SDAI, 35.6; mean CDAI, 33.3; 17.8% pts had received prior biologic DMARD. Significant changes (P≤0.05) from BL to wk 78 were observed for pts using the PSP vs PSP non-users in HAQ-DI (0.53 vs 0.39), DAS28(CRP) (−2.33 vs −1.97), SDAI (−24.5 vs −19.8), and CDAI (−22.66 vs −18.55) scores (Figure). Study discontinuation rates were significantly (P<0.001) lower among PSP-users vs PSP non- users (25.5% vs 41.6%). Reasons for discontinuations are listed in the Table.
Conclusions The final study results showed that, in pts with moderate to severe RA who initiated ADA, significantly better improvement in functional and clinical outcomes was achieved in the PSP users vs the PSP non-users. Improvements were achieved at early timepoints and continued to increase throughout the study.
Acknowledgements AbbVie funded the study and the analysis, and approved the abstract for submission. Medical writing assistance was provided by Gaurav Patki, PhD and Benjamin Wolfe, PhD from AbbVie.
Disclosure of Interest F. Van den Bosch Consultant for: AbbVie, Celgene, Janssen, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Pfizer, and UCB, A. Ostor Consultant for: Roche, Chugai, MSD, AbbVie, Pfizer, Novartis, Napp, and BMS, S. Wassenberg Consultant for: AbbVie, Celgene, Novartis, Pfizer, MSD, Lilly, Janssen and UCB, Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, MSD, Lilly, Janssen and UCB, J. K. Anderson Shareholder of: AbbVie, Employee of: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, C. Wang Shareholder of: AbbVie, Employee of: AbbVie, V. Garg Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie