Clinical and radiographic outcomes at 2 years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study

Huizinga, T W J; Conaghan, Philip G; Martin-Mola, Emilio; Schett, Georg; Amital, Howard; Xavier, Ricardo M; Troum, Orrin; Aassi, Maher; Bernasconi, Corrado Angelo; Dougados, Maxime (2014). Clinical and radiographic outcomes at 2 years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study. Annals of the rheumatic diseases, 74(1), pp. 35-43. BMJ Publishing Group 10.1136/annrheumdis-2014-205752

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OBJECTIVE

To assess the efficacy and safety of tocilizumab (TCZ) plus methotrexate/placebo (MTX/PBO) over 2 years and the course of disease activity in patients who discontinued TCZ due to sustained remission.

METHODS

ACT-RAY was a double-blind 3-year trial. Patients with active rheumatoid arthritis despite MTX were randomised to add TCZ to ongoing MTX (add-on strategy) or switch to TCZ plus PBO (switch strategy). Using a treat-to-target approach, open-label conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), other than MTX, were added from week 24 if Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) >3.2. Between weeks 52 and 104, patients in sustained clinical remission (DAS28-ESR <2.6 at two consecutive visits 12 weeks apart) discontinued TCZ and were assessed every 4 weeks for 1 year. If sustained remission was maintained, added csDMARDs, then MTX/PBO, were discontinued.

RESULTS

Of the 556 randomised patients, 76% completed year 2. Of patients entering year 2, 50.4% discontinued TCZ after achieving sustained remission and 5.9% achieved drug-free remission. Most patients who discontinued TCZ (84.0%) had a subsequent flare, but responded well to TCZ reintroduction. Despite many patients temporarily stopping TCZ, radiographic progression was minimal, with differences favouring add-on treatment. Rates of serious adverse events and serious infections per 100 patient-years were 12.2 and 4.4 in add-on and 15.0 and 3.7 in switch patients. In patients with normal baseline values, alanine aminotransferase elevations >3×upper limit of normal were more frequent in add-on (14.3%) versus switch patients (5.4%).

CONCLUSIONS

Treat-to-target strategies could be successfully implemented with TCZ to achieve sustained remission, after which TCZ was stopped. Biologic-free remission was maintained for about 3 months, but most patients eventually flared. TCZ restart led to rapid improvement.

TRIAL REGISTRATION NUMBER

NCT00810199.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
UniBE Contributor:	Bernasconi, Corrado Angelo
Subjects:	600 Technology > 610 Medicine & health
ISSN:	0003-4967
Publisher:	BMJ Publishing Group
Language:	English
Submitter:	Valentina Rossetti
Date Deposited:	01 Oct 2014 11:22
Last Modified:	05 Dec 2022 14:37
Publisher DOI:	10.1136/annrheumdis-2014-205752
PubMed ID:	25169728
Uncontrolled Keywords:	DMARDs (biologic) Methotrexate Rheumatoid Arthritis
URI:	https://boris.unibe.ch/id/eprint/58491