Stopping Tumor Necrosis Factor Inhibitor Treatment in Patients With Established Rheumatoid Arthritis in Remission or With Stable Low Disease Activity: A Pragmatic Multicenter, Open‐Label Randomized Controlled Trial

Abstract

Objective. Tumor necrosis factor inhibitor (TNFi) biologic agents are an effective treatment for rheumatoid arthritis (RA). It is unclear whether patients whose disease is in remission or who have stable low disease activity need to continue use of TNFi or can stop this treatment. This study was undertaken to assess whether patients with established RA who are in remission or have stable low disease activity can effectively and safely stop their TNFi therapy.Methods. The study was designed as a pragmatic multicenter, open-label randomized controlled trial. Inclusion criteria were a diagnosis of RA according to the American College of Rheumatology 1987 classification criteria, as well as use of a TNFi for at least 1 year along with a stable dose of disease-modifying antirheumatic drugs and a Disease Activity Score in 28 joints (DAS28) of <3.2 over the 6 months preceding trial inclusion. Patients were randomized in a 2:1 ratio to either stop or continue treatment with their current TNFi. Flare was defined as a DAS28 of ‡3.2 during the 12-month follow-up period and an increase in score of ‡0.6 compared to the baseline DAS28.Results. In total, 531 patients were allocated to the stop group and 286 to the TNFi continuation group. At 12 months, more patients had experienced a flare in the stop group (272 [51.2%] of 531) than in the continuation group (52 [18.2%] of 286; P < 0.001). The hazard ratio for occurrence of a flare after stopping TNFi was 3.50 (95% confidence interval [95% CI] 2.60-4.72). The mean DAS28 in the stop group was significantly higher during the followup period compared to that in the continuation group (P < 0.001). Of the 195 patients who restarted TNFi treatment after experiencing a flare and within 26 weeks after stopping, 165 (84.6%) had regained a DAS28 of <3.2 by 6 months later, and the median time to a regained DAS28 of <3.2 was 12 weeks (95% Cl 10.7-13.3). There were more

Factors influencing the choice of first- and second-line biologic therapy for the treatment of rheumatoid arthritis: real-life data from the Italian LORHEN Registry

“…Despite the constantly developing therapeutic options and an increasing shift of interest towards the management of withdrawing bDMARDs when remission is achieved [14][15][16], robust evidence is still needed on the appropriate prescription strategy of first-line bDMARD and switching strategy in real-life settings. To the best of our knowledge, this is the first study demonstrating that higher age and comorbidities influence the choice towards ABA and TCZ compared to TNFi in a large registry study.…”

Long-Term Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis: An Observational Analysis from the Corrona Rheumatoid Arthritis Registry

“…Comparable to the results of the Corrona analysis, the improvement of clinical characteristics and PROs in the trials peaked within the first year of treatment initiation, with a subsequent plateau. Although our study did not follow patients to determine outcomes after discontinuation of adalimumab therapy, other studies have shown that patients who discontinue treatment with TNF inhibitors have an increase in the number of flares and are less likely to maintain low disease activity [33,34]. It should be noted that patients enrolled in randomized clinical trials are selected because they have fewer significant comorbidities and fulfill very strict inclusion criteria, which may not reflect the real-world population.…”

Strategy for Dose Reduction and Discontinuation of Biological Agents in Rheumatoid Arthritis Remission

“…Moghadam и соавт. [29] в открытом РКИ наблю-дали 817 больных РА (средняя длительность заболевания составляла 11 лет), у которых не менее 6 мес сохранялась ремиссия или низкая активность болезни (DAS28 <3,2). Пациенты были рандомизированны на две группы: в пер-вой проводилась поддерживающая терапия ГИБП (n=286), во второй -ГИБП отменялись (n=531).…”

“…В 2013 г. был предложен индекс оценки актив-ности заболевания -Multi-Biomarkers Disease Activity (MBDA) [33,34]. Речь идет о создании коммерческого на-бора, включающего 12 биомаркеров (С-реактивный бе-лок -СРБ, эритроцитарный фактор роста, ИЛ6, лептин, ММП1, ММП3, резистин, сывороточный амилоидный бе-лок А, рецептор 1 ФНОα, сосудистую молекулу клеточной адгезии 1, фактор роста эндотелия сосудов А, хрящевой гликопротеин YKL40), который позволил бы разработать алгоритм для классификации активности РА по шкале от 0 до 100: низкая (<29), средняя (29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40) и высокая (>40). Позднее J. Rech и соавт.…”