Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial(STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study)

Abstract

ClinicalTrials.gov: NCT00780793; EudraCT identifier: 2007-004483-41.

Dose-Tapering Of TNF Inhibitors in Daily Rheumatology Practice Enables the Maintenance of Clinical Efficacy While Improving Cost-Effectiveness

“…In a cohort of 51 RA patients with Ifx Van der Maas et al observed that dose titration was feasible in patients with inactive disease and also demonstrated important cost savings with this strategy [4]. Recently, two randomized controlled trials on tapering of Ada and Etn in RA patients executed in daily clinical practice have been published [12,14]. Both clinical trials conclude that tapering is feasible in RA patients without impacting structural damage progression [12] or the appearance of flares [14].…”

“…Recently, two randomized controlled trials on tapering of Ada and Etn in RA patients executed in daily clinical practice have been published [12,14]. Both clinical trials conclude that tapering is feasible in RA patients without impacting structural damage progression [12] or the appearance of flares [14]. Furthermore, published data suggest that a tapering strategy may be efficient to maintain remission or LDA in most patients with axial spondyloarthritis [9,10,29].…”

“…However, concerns about the risk of disease flares, the progression of radiological damage and the need to increase other medications with potential side effects have limited its implementation. In the last years some publications on tapering and discontinuation of TNFi have appeared [11][12][13][14], most of them taking part of randomized control trials. Others are based on disease activity guided strategy of TNFi dose reduction to discontinuation [15].…”

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

“…Целью открытого РКИ STRASS (Spacing of TNF-blocker injections in Rheumatoid Arthritis Study) было изучение ре-зультатов снижения дозировки ГИБП за счет прогрес-сивного увеличения интервала между инъекциями ЭТЦ (50 мг/нед) и АДА (40 мг/2 нед) по сравнению со стандар-ной схемой [22]. Такие пациенты не менее 1 года получали ингибиторы ФНОα в виде монотерапии или в комбинации с БПВП (МТ или лефлуномид), находились в ремиссии ≥6 мес и не имели за последний год прогрессирования структурных изменений.…”

“…Так, например, значения индекса DAS28 >2,2 при инициировании отмены препара-та, присутствие ревматоидного фактора и антител к цикли-ческому цитруллинированному пептиду (АЦЦП) являются факторами риска обострения заболевания [14,15,22,30]. Считается, что продолжение терапии БПВП после отмены ГИБП способствует сохранению ремиссии.…”