Assessing the Real-World Impact of Earlier Initiation of Anti-Tumor Necrosis Factor vs. Conventional Synthetic DMARDs on Clinical and Patient-Reported Outcomes in Patients With Rheumatoid Arthritis in Europe
Author(s)
Daniel Aletaha, MD, MS, MBA1, Carmen Bremer, PhD2, Jack Milligan, BA, MA3, Ethan Cao, MSc4, Rachael Meadows, BSc3, Xenofon Baraliakos, MD, Prof.5.
1Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 2Sandoz International GmbH, Holzkirchen, Germany, 3Adelphi Real World, Macclesfield, United Kingdom, 4Sandoz Inc., Princeton, NJ, USA, 5Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Herne, Germany.
1Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 2Sandoz International GmbH, Holzkirchen, Germany, 3Adelphi Real World, Macclesfield, United Kingdom, 4Sandoz Inc., Princeton, NJ, USA, 5Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Herne, Germany.
OBJECTIVES: This research aims to compare clinician-reported outcomes (ClinROs) and patient-reported outcomes (PROs) in rheumatoid arthritis (RA) patients receiving anti-TNF as first-line targeted therapy (1L) versus those on conventional synthetic DMARDs (csDMARDs) never prescribed targeted therapy (TT-naïve).
METHODS: Data were drawn from the Adelphi RA Disease Specific Programme™, a cross-sectional survey in France, Italy, Germany, Spain and the UK from July 2023-August 2024, where rheumatologists and their consulting RA patients provided ClinROs and PROs. These outcomes were compared between anti-TNF-1L and TT-naïve csDMARD patients after ≥3 months of treatment using inverse probability weighted regression adjusting for baseline characteristics, disease history and treatment duration. ClinROs of Sandoz adalimumab (SZ-ADL) patients were also compared with csDMARD using the same method.
RESULTS: Physicians provided ClinROs for 714 patients in the anti-TNF vs. csDMARD analysis (n=483, n=231) and 140 patients provided PROs (n=87, n=53). For the SZ-ADL vs. csDMARD analysis, ClinROs from 476 patients (n=245, n=231) were collected.
Anti-TNF ClinROs had higher DAS-28 remission rates (58.11% vs. 43.29%, p=0.0031), fewer symptoms (mean=1.47 vs. 1.87, p=0.0275), higher physician treatment satisfaction (93.06% vs. 81.69%, p=0.0096), and more complete treatment adherence (56.70% vs. 45.96%, p=0.0383) than csDMARD. SZ-ADL had fewer symptoms (mean=1.30 vs. 1.83, p=0.0053) and higher physician treatment satisfaction (92.69% vs. 82.18%, p=0.012) than csDMARD. Anti-TNF/SZ-ADL also had higher reports of no fatigue and no pain but were not significant.
Anti-TNF PROs had lower HAQ-DI disability (mean=0.51 vs. 0.73, p= 0.0305), more often had mild RA (53.63% vs. 31.38%, p=0.0132), mild pain (57.56% vs. 25.43%, p=0.0002), and less activity impairment (WPAI=22.52% vs. 32.70%, p=0.0398) than csDMARD. Lower fatigue and higher treatment satisfaction were reported but were not significant.
CONCLUSIONS: Earlier initiation of anti-TNFs may increase remission rates and treatment satisfaction and reduce disability and activity impairment for RA patients. Residual confounding variables may limit analysis interpretation.
METHODS: Data were drawn from the Adelphi RA Disease Specific Programme™, a cross-sectional survey in France, Italy, Germany, Spain and the UK from July 2023-August 2024, where rheumatologists and their consulting RA patients provided ClinROs and PROs. These outcomes were compared between anti-TNF-1L and TT-naïve csDMARD patients after ≥3 months of treatment using inverse probability weighted regression adjusting for baseline characteristics, disease history and treatment duration. ClinROs of Sandoz adalimumab (SZ-ADL) patients were also compared with csDMARD using the same method.
RESULTS: Physicians provided ClinROs for 714 patients in the anti-TNF vs. csDMARD analysis (n=483, n=231) and 140 patients provided PROs (n=87, n=53). For the SZ-ADL vs. csDMARD analysis, ClinROs from 476 patients (n=245, n=231) were collected.
Anti-TNF ClinROs had higher DAS-28 remission rates (58.11% vs. 43.29%, p=0.0031), fewer symptoms (mean=1.47 vs. 1.87, p=0.0275), higher physician treatment satisfaction (93.06% vs. 81.69%, p=0.0096), and more complete treatment adherence (56.70% vs. 45.96%, p=0.0383) than csDMARD. SZ-ADL had fewer symptoms (mean=1.30 vs. 1.83, p=0.0053) and higher physician treatment satisfaction (92.69% vs. 82.18%, p=0.012) than csDMARD. Anti-TNF/SZ-ADL also had higher reports of no fatigue and no pain but were not significant.
Anti-TNF PROs had lower HAQ-DI disability (mean=0.51 vs. 0.73, p= 0.0305), more often had mild RA (53.63% vs. 31.38%, p=0.0132), mild pain (57.56% vs. 25.43%, p=0.0002), and less activity impairment (WPAI=22.52% vs. 32.70%, p=0.0398) than csDMARD. Lower fatigue and higher treatment satisfaction were reported but were not significant.
CONCLUSIONS: Earlier initiation of anti-TNFs may increase remission rates and treatment satisfaction and reduce disability and activity impairment for RA patients. Residual confounding variables may limit analysis interpretation.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO16
Topic
Clinical Outcomes, Patient-Centered Research, Real World Data & Information Systems
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes, Comparative Effectiveness or Efficacy
Disease
Biologics & Biosimilars, Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal), No Additional Disease & Conditions/Specialized Treatment Areas, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)