Leslie R Harrold1, George W Reed2, Ashwini Shewade2, Robert Magner2, Katherine C Saunders2, Ani John2, Joel M Kremer2, Jeffrey D Greenberg2. 1. From the University of Massachusetts Medical School, Worcester; Corrona LLC, Southborough, Massachusetts; Genentech Inc., South San Francisco, California; Albany Medical College and The Center for Rheumatology, Albany; New York University (NYU) School of Medicine, New York, New York, USA.L.R. Harrold, MD, MPH, Department of Medicine, University of Massachusetts Medical School; G.W. Reed, PhD, Department of Medicine, University of Massachusetts Medical School, and Corrona LLC; A. Shewade, MS, Genentech Inc.; R. Magner, MPH, Department of Medicine, University of Massachusetts Medical School; K.C. Saunders, MS, Corrona LLC; A. John, BSN, MPH, Genentech Inc.; J.M. Kremer, MD, Department of Rheumatology, Albany Medical College, and The Center for Rheumatology; J.D. Greenberg, MD, MPH, Department of Medicine, Division of Rheumatology, NYU School of Medicine. Leslie.Harrold@umassmed.edu. 2. From the University of Massachusetts Medical School, Worcester; Corrona LLC, Southborough, Massachusetts; Genentech Inc., South San Francisco, California; Albany Medical College and The Center for Rheumatology, Albany; New York University (NYU) School of Medicine, New York, New York, USA.L.R. Harrold, MD, MPH, Department of Medicine, University of Massachusetts Medical School; G.W. Reed, PhD, Department of Medicine, University of Massachusetts Medical School, and Corrona LLC; A. Shewade, MS, Genentech Inc.; R. Magner, MPH, Department of Medicine, University of Massachusetts Medical School; K.C. Saunders, MS, Corrona LLC; A. John, BSN, MPH, Genentech Inc.; J.M. Kremer, MD, Department of Rheumatology, Albany Medical College, and The Center for Rheumatology; J.D. Greenberg, MD, MPH, Department of Medicine, Division of Rheumatology, NYU School of Medicine.
Abstract
OBJECTIVE: To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis. METHODS: Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models. RESULTS: Patients (n = 265) were followed for 12 months with a mean change in CDAI of -8.1 (95% CI -9.8 - -6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of -10.1 (95% CI -13.2 - -7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of -10.5 (95% CI -12.9 - -8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22-0.73), which was robust to 4 different adjusted models (OR range 0.38-0.44). CONCLUSION: A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.
OBJECTIVE: To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis. METHODS: Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumornecrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models. RESULTS:Patients (n = 265) were followed for 12 months with a mean change in CDAI of -8.1 (95% CI -9.8 - -6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of -10.1 (95% CI -13.2 - -7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of -10.5 (95% CI -12.9 - -8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22-0.73), which was robust to 4 different adjusted models (OR range 0.38-0.44). CONCLUSION: A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.
Authors: A Krause; P M Aries; S Berger; C Fiehn; H Kellner; H-M Lorenz; L Meier; G A Müller; U Müller-Ladner; A Schwarting; H-P Tony; M A Peters; J Wendler Journal: Z Rheumatol Date: 2019-11 Impact factor: 1.372
Authors: Leslie R Harrold; George W Reed; Daniel H Solomon; Jeffrey R Curtis; Mei Liu; Jeffrey D Greenberg; Joel M Kremer Journal: Arthritis Res Ther Date: 2016-12-01 Impact factor: 5.156
Authors: Nadia M T Roodenrijs; Attila Hamar; Melinda Kedves; György Nagy; Jacob M van Laar; Désirée van der Heijde; Paco M J Welsing Journal: RMD Open Date: 2021-01