Universität zu Köln

Emery, Paul, Mease, Philip J., Rubbert-Roth, Andrea, Curtis, Jeffrey R., Mueller-Ladner, Ulf, Gaylis, Norman B., Williams, Sarah, Reynard, Mark and Tyrrell, Helen (2011). Retreatment with rituximab based on a treatment-to-target approach provides better disease control than treatment as needed in patients with rheumatoid arthritis: a retrospective pooled analysis. RHEUMATOLOGY, 50 (12). S. 2223 - 2233. OXFORD: OXFORD UNIV PRESS. ISSN 1462-0324

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Abstract

Methods. Four hundred and ninety-three RA patients with an inadequate response to MTX recruited into rituximab Phase II/III studies received further courses of open-label rituximab based on two approaches: (i) treatment to target (TT): patients assessed 24 weeks after each course and retreated if not in remission [DAS in 28 joints based on ESR (DAS-28-ESR) epsilon 2.6]; (ii) treatment as needed (PRN): patients retreated at the physician's discretion epsilon 24 weeks following the first course and epsilon 16 weeks following further courses, if both swollen and tender joint counts were epsilon 8. All courses consisted of i.v. rituximab 2 x 1000 mg 2 weeks apart plus MTX. Observed data were analysed according to treatment strategy. Results. Multiple courses of rituximab maintained or improved responses irrespective of regimen. TT provided tighter control of disease activity with significantly greater improvements in DAS-28-ESR and lower HAQ-disability index scores vs PRN. TT resulted in significantly more patients achieving major clinical response. PRN resulted in recurrence of disease symptoms between courses, with TT significantly reducing the incidence of RA flares. Despite more frequent retreatment with TT compared with PRN, the rates of serious adverse events and serious infections were comparable between regimens. Conclusions. Retreatment with rituximab based on 24-week evaluations and to a target of DAS-28-ESR remission leads to improved efficacy and tighter control of disease activity compared with PRN without a compromised safety profile. TT may be the preferable rituximab treatment regimen for patients with RA.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Emery, Paul UNSPECIFIED UNSPECIFIED UNSPECIFIED Mease, Philip J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rubbert-Roth, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Curtis, Jeffrey R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller-Ladner, Ulf UNSPECIFIED UNSPECIFIED UNSPECIFIED Gaylis, Norman B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Williams, Sarah UNSPECIFIED UNSPECIFIED UNSPECIFIED Reynard, Mark UNSPECIFIED UNSPECIFIED UNSPECIFIED Tyrrell, Helen UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-484969
DOI:	10.1093/rheumatology/ker253
Journal or Publication Title:	RHEUMATOLOGY
Volume:	50
Number:	12
Page Range:	S. 2223 - 2233
Date:	2011
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	1462-0324
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CONTROLLED-TRIAL; CLINICAL-TRIALS; TIGHT CONTROL; DOUBLE-BLIND; TASK-FORCE; EFFICACY; SAFETY; RECOMMENDATIONS; THERAPY; MANAGEMENT Multiple languages Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48496