Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial

Abstract

IntroductionConsidering a lack of efficacy data in patients with early rheumatoid arthritis (eRA) presenting without classical markers of poor prognosis, we compared methotrexate (MTX) with or without step-down glucocorticoids in the CareRA trial.MethodsDisease-modifying antirheumatic drug–naïve patients with eRA were stratified into a low-risk group based on prognostic markers that included non-erosiveness, anti–citrullinated protein antibodies and rheumatoid factor negativity and low disease activity (Disease Activity Score in 28 joints based on C-reactive protein (DAS28(CRP)) ≤3.2). Patients were randomized to 15 mg of MTX weekly (MTX with tight step-up (MTX-TSU)) or 15 mg of MTX weekly with prednisone bridging, starting at 30 mg and tapered to 5 mg daily from week 6 (COmbinatie therapie bij Reumatoïde Artritis (COBRA Slim)). A TSU approach was applied. Outcomes assessed were DAS28(CRP)-determined remission, cumulative disease activity, Health Assessment Questionnaire (HAQ) scores and adverse events (AEs) after 16 treatment weeks.ResultsWe analyzed 43 COBRA Slim and 47 MTX-TSU patients and found that 65.1% in the COBRA Slim group and 46.8% in the MTX-TSU group reached remission (P = 0.081). Mean ± standard deviation area under the curve values of DAS28(CRP) were 13.84 ± 4.58 and 11.18 ± 4.25 for the MTX-TSU and COBRA Slim patients, respectively (P = 0.006). More COBRA Slim patients had an HAQ score of 0 (51.2% versus 23.4%, P = 0.006) at week 16. Therapy-related AEs between groups did not differ.ConclusionIn patients with low-risk eRA, MTX with step-down glucocorticoid bridging seems more efficacious than MTX step-up monotherapy, with a comparable number of AEs observed over the first 16 treatment weeks.Trial registrationEU Clinical Trials Register Identifier: EudraCT number 2008-007225-39. Registered 5 November 2008.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-015-0611-8) contains supplementary material, which is available to authorized users.

A general practice perspective on early rheumatoid arthritis management: A qualitative study from Flanders

“…Initial intensive treatment strategies combining classical disease modifying anti-rheumatic drugs with rapid remission inducing agents like glucocorticoids or biologicals are the most effective and safe option for patients with early RA in achieving the 'window of opportunity' to control the disease (10)(11)(12)(13).…”

The optimal combination therapy for the treatment of early rheumatoid arthritis

“…Hence, physicians are possibly more inclined to use a conservative approach in patients perceived as having a low risk, for example, having a less severe RA risk profile with less damage to occur. After 16 weeks of treatment, MTX with GCs for remission induction showed however better efficacy and functionality results, and remarkably, a comparable safety profile [82,83]. These data are answering recent requests for more attention towards these so-called good prognosis patients [84] and provide future therapy directions for all early RA patients given the fact that current prognostic matrices are not useful in daily practice [85].…”

“…Both are in line concerning the use of MTX as the gold Reproduced with permission from [83]. ACPA: Anti-citrullinated protein antibody.…”

The 2016 Eular Guidelines for the Diagnosis and Treatment of Early Arthritis

“…Данные метаанализа нескольких РКИ (хотя только небольшое число исследований было проведено у пациен-тов с ранним артритом) свидетельствуют о том, что систем-ное применение ГК улучшает «клинические» и «структур-ные» исходы РА [56, 81,82]. Обращается особое внимание на риск НР (инфекционных осложнений и кардиоваску-лярной патологии, увеличения массы тела, артериальной гипертензии, диабета, катаракты, остеопороза), который нарастает при достижении высокой кумулятивной дозы ГК и их длительном приеме [83][84][85][86][87][88][89][90][91].…”