Predicting achievement of the treatment targets at 6 months from 3-month response levels in rheumatoid arthritis: data from real-life follow-up in the NOR-DMARD study

Abstract

ObjectiveWhen 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.MethodsWe 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.ResultsNot 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).ConclusionLevels 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.

Reproducibility and rigor in rheumatology research

“…Rheumatology research projects using real-world data have included several rheumatological diagnoses, but the majority of data focuses on rheumatoid arthritis (RA) (24). The data collected by RA registries in various countries (27)(28)(29)(30)(31)(32) allows for a better understanding of the patient's disease outcomes, responses to different therapies, particularly with the emerging use of biologics and biosimilars in rheumatology, and safety ofe these agents (33). A similar role of real-world data exists in other rheumatological diseases such as systemic lupus erythematosus, ankylosing spondylitis (AS), psoriatic arthritis (PsA), systemic sclerosis, idiopathic myositis, and vasculitis (24).…”

The role of timely rheumatoid arthritis treatment effectiveness control

“…Результаты настоящего исследования подтверждают актуальность рекомендаций «Лечение до достижения цели» (Treat to Target) в реальной клинической практике и необходимость четкого соблюдения сроков контроля активности заболевания для успешного лечения РА [10]. В 2018 г. опубликованы результаты крупного проспективного исследования NOR-DMARD [7], в котором показано, что контроль активности РА через 3 мес от начала терапии является ключевым моментом успешного лечения, так как позволяет оценить вероятность наступления ремиссии. Так, у пациентов с высокой активностью, не достигших снижения активности на 70% и более через 3 мес, вероятность достижения ремиссии в дальнейшем значительно снижается.…”

“…Ранняя диагностика и своевременная рациональная полноценная терапия РА позволяют достичь стойкой ремиссии заболевания, улучшения качества жизни, снижения частоты инвалидизации. Однако для контроля эффективности терапии и подбора/смены лекарственного препарата необходим своевременный мониторинг пациентов [7,8].…”

Treatment Response to Tumor Necrosis Factor Inhibitors and Methotrexate Monotherapy in Adults With Juvenile Idiopathic Arthritis: Data From NOR-DMARD

“…Assessments and data collection is performed by the treating physician or a study nurse. 21,22 The study complies with the Declaration of Helsinki. All patients have given informed, written consent prior to inclusion.…”

“…We used data from the Norwegian disease-modifying anti-rheumatic drug study (NOR-DMARD), an ongoing prospective, longitudinal observational study initiated in year 2000 including six rheumatology centers, covering about 1/3 of the Norwegian population. [20][21][22][23] When enrolled, patients are assessed at baseline and after 3, 6 and 12 months. After 12-months follow-up, patients were assessed annually up to 2012, after 2012 all patients have been followed every 6 months.…”