Objective When initiating a new therapy in patients with rheumatoid arthritis (RA), current treatment recommendations suggest escalating therapy in case of poor clinical improvement by 3 months or if the treatment target has not been reached by 6 months. We investigated which disease activity improvement levels at 3 months predicted achievement of the treatment targets at 6 months in a real-life clinical setting.
Methods We included 1610 patients with RA enrolled in the NOR-DMARD study between 2000 and 2012. Analyses were performed for the total group of patients and repeated for subgroups stratified by baseline disease activity, disease duration or treatment with methotrexate or a tumour necrosis factor inhibitor. We used a diagnostic test approach to explore the associations between 3-month response and 6-month outcome.
Results Not achieving 50% improvement in Simplified Disease Activity Index (SDAI) by 3 months significantly decreased the likelihood of reaching remission at 6 months in all subgroups (negative likelihood ratios (LRs−) 0.15–0.36). Patients with high disease activity when initiating treatment were likely to fail reaching remission if they achieved less than SDAI 70% response by 3 months (LR− 0.25 and negative predictive value 0.98). Achieving a major response (SDAI 85%) at 3 months significantly increased the likelihood of reaching remission at 6 months (LRs+ 6.56).
Conclusion Levels of 3-month disease activity improvement can inform clinicians when deciding to continue or adjust ongoing therapy in a treat-to-target strategy aiming for remission or low disease activity within 6 months. The required levels of 3-month improvement varied with baseline disease activity.
- rheumatoid arthritis
- disease activity
- outcomes research
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Contributors Study design: VN, JS, ICO, TKK, JSS, DA and EAH. Data acquisition: GB, FK, ER, AW and TKK. Data analyses: VN, JS and ICO. Manuscript preparation: VN, JS, ICO, EKK, TU, TKK, JSS, DA and EAH. All authors critically revised the manuscript and approved the final version.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: ICO has received personal fees from Pfizer; TU has received personal fees from Biogen, Bristol-Myers Squibb, Eli Lilly, Janssen, MSD, Novartis and Roche; GB has received personal fees from AbbVie, Pfizer and UCB; TKK has received fees for speaking and/or consulting from AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Epirus, Merck-Serono MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB; JSS has received grants, expert advice and/or speaking engagements from AbbVie, Amgen, Astra-Zeneca, BMS, Celltrion, Eli Lilly, Gilead, Janssen, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung and UCB; DA has received fees for speaking and/or consulting from AbbVie, BMS, Eli Lilly, Janssen, MSD, Pfizer, Roche and UCB; EAH has received grants from AbbVie, MSD, Pfizer and UCB and personal fees from Celgene, Eli Lilly, Pfizer, Roche and UCB; no other relationships or activities that could appear to have influenced the submitted work.
Patient consent Obtained.
Ethics approval Regional Committee for Medical and Health Research Ethics, South-Eastern Norway.
Provenance and peer review Not commissioned; externally peer reviewed.
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