RESEARCH - Tight control and intensified COBRA combination

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Published Online First: 14 July 2008. doi:10.1136/ard.2008.090712

ls of the Rheumatic Diseases 2008;67:1574-1577

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CLINICAL AND EPIDEMIOLOGICAL RESEARCH

Tight control and intensified COBRA combination treatment in early

rheumatoid arthritis: 90% remission in a pilot trial

L H D van Tuyl 1, W F Lems 2, A E Voskuyl 2, P J S M Kerstens 3, P

Garnero 4, B A C Dijkmans 2, M Boers 5

1 Department of Clinical Epidemiology & Biostatistics, VU University

Medical Center, Amsterdam, The Netherlands

2 Department of Rheumatology, VU University Medical Center, Amsterdam,

The Netherlands

3 Jan van Breemen Institute, Amsterdam, The Netherlands

4 INSERM Unit 664 and Synarc, Lyon, France

5 VU University Medical Center, Clinical Epidemiology & Biostatistics,

Amsterdam, The Netherlands

Objective: To investigate the efficacy and feasibility of an intensive

combination treatment in early rheumatoid arthritis (RA) combined with

monitoring both disease activity and cartilage degradation.

Methods: In a pilot trial, 21 patients with active early RA (mean

DAS28 5.3; mean disease duration 3 months) were treated with COBRA

treatment comprising sulfasalazine, methotrexate and high-dose

step-down prednisolone, intensified by adding hydroxychloroquine and

continued low-dose prednisolone. In addition, based on measurements of

disease activity or a marker of cartilage degradation (CTX-II),

treatment adjustments were possible with methotrexate intensification

after 8 or 21 weeks; and with infliximab after 21 weeks.

Results: Nineteen of 21 patients (90%) were in remission (DAS28 <2.6)

after 40 weeks (8 weeks, 57%; 21 weeks, 76%). American College of

Rheumatology (ACR) criteria, ACR20, 50, 70 and 90 improvements rates

were 100%, 95%, 71% and 43% respectively. CTX-II excretion decreased

by mean (SD) 347(292) ng/mmol creatinine, but only 50% of patients

reduced their CTX-II excretion below the cut-off point. The two

monitoring groups showed no significant difference in remission

according to DAS score or CTX-II excretion, despite a trend towards

more intensive treatment in the CTX-II group. Treatment

intensification was feasible according to protocol.

Conclusions: This small pilot study suggests that intensified and

tightly controlled COBRA treatment is uniquely effective in early RA.

Trial registration number: ISRCTN96372677.

http://ard.bmj.com/cgi/content/abstract/67/11/1574?etoc

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