Universität zu Köln

Burmester, Gerd R., Rigby, William F., van Vollenhoven, Ronald F., Kay, Jonathan ORCID: 0000-0002-8970-4260, Rubbert-Roth, Andrea, Blanco, Ricardo, Kadva, Alysha and Dimonaco, Sophie (2017). Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann. Rheum. Dis., 76 (7). S. 1279 - 1285. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-2060

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Abstract

Objective Investigate whether the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) are maintained to week 104. Methods Methotrexate (MTX)-naive patients with early progressive RA were randomly assigned to double-blind 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ +placebo or placebo+MTX for 104 weeks. Patients not receiving 8 mg/kg TCZ and not achieving Disease Activity Score-28 joints (DAS28-erythrocyte sedimentation rate (ESR)) <= 3.2 at week 52 switched to escape therapy (8 mg/kg TCZ+MTX). Analyses were exploratory. Results Intent-to-treat and safety populations included 1157 and 1153 patients, respectively. DAS28-ESR remission (<2.6) rates were maintained from weeks 52 to 104 (eg, 8 mg/kg TCZ+MTX, 49.3% to 47.6%). Placebo +MTX and 4 mg/kg TCZ+MTX escape patients' week 104 response rates were 51.4% and 30.5%, respectively. Inhibition of radiographic progression was maintained with 8 mg/kg TCZ (eg, 8 mg/kg TCZ+MTX mean (SD) change from baseline in modified total Sharp score: 0.13 (1.28), week 52; 0.19 (2.08), week 104). The safety profile of TCZ was consistent with that of previous reports. Conclusions Patients with early RA treated with TCZ monotherapy or TCZ+MTX maintained clinical benefits during their second year of treatment with no new safety signals.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Burmester, Gerd R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rigby, William F. UNSPECIFIED UNSPECIFIED UNSPECIFIED van Vollenhoven, Ronald F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kay, Jonathan UNSPECIFIED orcid.org/0000-0002-8970-4260 UNSPECIFIED Rubbert-Roth, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Blanco, Ricardo UNSPECIFIED UNSPECIFIED UNSPECIFIED Kadva, Alysha UNSPECIFIED UNSPECIFIED UNSPECIFIED Dimonaco, Sophie UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-226467
DOI:	10.1136/annrheumdis-2016-210561
Journal or Publication Title:	Ann. Rheum. Dis.
Volume:	76
Number:	7
Page Range:	S. 1279 - 1285
Date:	2017
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1468-2060
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language INTERLEUKIN-6 RECEPTOR INHIBITION; DOUBLE-BLIND; ADALIMUMAB Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22646