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OP0262 Similar Clinical and Radiological Outcome in The Cobra and Cobra-Light Treatment Group 4 Years after Initiation of The Cobra-Light Trial
  1. N. Konijn1,
  2. L. van Tuyl1,
  3. M. Boers1,2,
  4. D. den Uijl1,
  5. M. ter Wee1,2,
  6. P. Kerstens3,4,
  7. A. Voskuyl1,
  8. D. van Schaardenburg3,5,
  9. M. Nurmohamed1,3,
  10. W. Lems1,3
  1. 1Rheumatology, Amsterdam Rheumatology and immunology Center, VU University Medical Center
  2. 2Epidemiology & Biostatistics, VU University Medical Center
  3. 3Rheumatology, Amsterdam Rheumatology and immunology Center, Reade, Amsterdam
  4. 4Rheumatology, Westfriesgasthuis, Hoorn
  5. 5Rheumatology, Amsterdam Rheumatology and immunology Center, Academic Medical Center, Amsterdam, Netherlands

Abstract

Background COBRA and COBRA-light combination therapy are equally effective treatments for early rheumatoid arthritis (RA) after 26 and 52 weeks [1,2], but the long-term effect of start with COBRA-light therapy is unknown.

Objectives To investigate the efficacy of initial COBRA and COBRA-light combination therapy after a 4 year follow-up period. A detailed analysis of long-term safety will be presented separately.

Methods In the COBRA-light trial, 164 patients with recent-onset RA were randomized to either COBRA (prednisolone 60 mg/day, tapered to 7.5 mg/day in 6 weeks; MTX 7.5 mg/week and sulfasalazine 2 g/day; n=81) or COBRA-light therapy (prednisolone 30 mg/day, tapered to 7.5 mg/day in 8 weeks and MTX escalated to 25 mg/week in 8 weeks; n=83). In the period of 26 to 52 weeks; treatment intensification of MTX and addition of etanercept was protocollized (treat-to-target). After 52 weeks, treatment was continued without protocol. Four years after trial initiation, all patients who had initiated therapy (n=162) were invited to participate in the COBRA-light extension study. Main outcomes were: Disease Activity Score in 44 joints (DAS), Health Assessment Questionnaire (HAQ), Sharp – Van der Heijde radiographic Score (SHS) and ACR/EULAR Boolean remission. Longitudinal mixed modeling (DAS), TOBIT (HAQ), and GEE analyses (SHS: log negative binomial; Boolean remission: logit binomial) were performed in STATA.

Results A total of 149 out of 162 original trial patients participated in the extension study (77 COBRA and 72 COBRA-light patients); 2 COBRA vs. 3 COBRA-light patients had died, 1 vs. 5 patients were not able or willing to participate, and 1 vs. 1 patient were in drug-free remission and out of care. After the 52 weeks trial period, 43% COBRA vs. 42% COBRA-light patients used prednisolone for ≥90 days, 34% vs. 44% patients switched to other DMARDs, and 39% vs. 28% patients used biologicals during the follow-up period. After mean 4 years follow-up, 49% COBRA vs. 47% COBRA-light patients had DAS<1.6, 50% vs. 48% had HAQ≤0.5, and 29% vs. 36% had SHS=0. Boolean remission occurred significantly more in the COBRA-light group (12% COBRA vs. 26% COBRA-light; p=0.04). Longitudinal data analyses showed equal effects of both COBRA and COBRA-light therapy on DAS, HAQ, SHS and Boolean remission over time. HAQ and SHS, both indicators of long-term efficacy, showed equal progression in both treatment groups during the 4 year follow-up period (Fig. 1).

Conclusions Early RA patients initially treated with COBRA or COBRA-light therapy showed similar outcome over a 4 year follow-up period.

  1. Den Uyl, ARD 2014,73:1071–8;

  2. Ter Wee, ARD 2015,74:1233–40

Disclosure of Interest N. Konijn: None declared, L. van Tuyl: None declared, M. Boers Consultant for: MundiPharma, Pfizer, D. den Uijl: None declared, M. ter Wee: None declared, P. Kerstens: None declared, A. Voskuyl: None declared, D. van Schaardenburg: None declared, M. Nurmohamed: None declared, W. Lems Grant/research support from: This study was supported by an unrestricted grant from Pfizer

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