Treating to a target in established active rheumatoid arthritis patients receiving a tumor necrosis factor inhibitor: results from a real-world cluster-randomized adalimumab trial
Janet E Pope, Boulos Haraoui, Emmanouil Rampakakis, Eliofotisti Psaradellis, Carter Thorne, John S Sampalis, Optimization of Adalimumab Trial Investigators, Milton Baker, Andrew Chow, Frances Leung, Murray Baron, Alf Cividino, Martin Lee, Isabelle Fortin, Hector Arbiillaga, Alia Khan, Majed Khraishhi, Michel Gagne, Eric Grant, Anna Maria Jaroszynska, Sherry Rohekar, Janet Markland, Raman Joshi, Tulio Scocchia, Souad Shatshat, Mark Hazeltine, Bindu Nair, Suneil Kapur, Jerieta Waltin-James, Art Karasik, Martin Willans, Oleg Zadorozny, Nicole LeRiche, Vandana Ahluwalia, Proton Rahman, Yatish Setty, Irene Vasiliu, Janet E Pope, Boulos Haraoui, Emmanouil Rampakakis, Eliofotisti Psaradellis, Carter Thorne, John S Sampalis, Optimization of Adalimumab Trial Investigators, Milton Baker, Andrew Chow, Frances Leung, Murray Baron, Alf Cividino, Martin Lee, Isabelle Fortin, Hector Arbiillaga, Alia Khan, Majed Khraishhi, Michel Gagne, Eric Grant, Anna Maria Jaroszynska, Sherry Rohekar, Janet Markland, Raman Joshi, Tulio Scocchia, Souad Shatshat, Mark Hazeltine, Bindu Nair, Suneil Kapur, Jerieta Waltin-James, Art Karasik, Martin Willans, Oleg Zadorozny, Nicole LeRiche, Vandana Ahluwalia, Proton Rahman, Yatish Setty, Irene Vasiliu
Abstract
Objective: In early rheumatoid arthritis (RA), treating to a target is more effective than routine care (RC). Our aim was to determine if treating to a target has better outcomes than RC in established active RA.
Methods: We used a real-world, 18-month cluster-randomized trial in established active RA patients treated with adalimumab. Physicians were randomized to RC, treating to a Disease Activity Score in 28 joints (DAS28) of <2.6 (DAS group), or treating to a 0 of 28 swollen joint count (SJC; 0-SJC group).
Results: Among the 308 enrolled patients, 109 (35.4%) were randomized to RC, 100 (32.5%) to the DAS group, and 99 (32.1%) to the 0-SJC group. When adjusting for baseline DAS28, a comparable but significant (P < 0.001) improvement in DAS28 was observed at 12 months for all groups (DAS28 mean score 3.1, 3.4, and 3.2, respectively). There were no significant between-group differences in the improvement of clinical parameters and patient-reported outcomes with the exception of the mean change in patient satisfaction over time (P = 0.020), which was highest in the DAS group. Time to achieving good/moderate European League Against Rheumatism (EULAR) response was significantly shorter in the targeted treatment groups compared to RC (adjusted hazard ratio [HR] for the DAS-group 2.99 [95% confidence interval (95% CI) 1.71-5.24] and HR for the 0-SJC group 1.86 [95% CI 1.09-3.13]). The dropout rate was 52.3% in RC, 27% in the DAS group, and 22.2% in the 0-SJC group (P < 0.001).
Conclusion: All groups experienced significant improvements at 18 months of treatment with adalimumab. Treating to target in established RA did not differ from RC in terms of therapeutic end point achievement for patients remaining on treatment. However, time to achieving good/moderate EULAR response was significantly shorter in the targeted treatment groups compared to RC and, importantly, the dropout rate was significantly lower with targeted treatment.
Trial registration: ClinicalTrials.gov NCT01585064.
Copyright © 2013 by the American College of Rheumatology.
Source: PubMed