June 20, 2007 Early treatment with a combination of methotrexate and infliximab may be effective as remission induction therapy and alter the course of early rheumatoid arthritis (RA), according to data presented at EULAR 2007, the Annual European Congress of Rheumatology in Barcelona, Spain.
At four year follow up, over half (51%) of the patients who started treatment with a combination of methotrexate and infliximab in the BeSt ('Behandel--Strategieën' or 'treatment strategies') trial had been able to discontinue treatment with infliximab and maintained a good response (Disease Activity Score (DAS) d2.4). 41 patients were still taking methotrexate monotherapy at trial end. Almost one in five (17%) of patients had reached clinical remission (DAS <1.6), with minimal joint damage progression, and were no longer receiving any anti-rheumatic drugs,
Study leader Dr Cornelia F. Allaart commented: "Our findings indicate that clinical remission from RA is achievable provided effective treatment - such as the infliximab methotrexate combination we used in the fourth arm of this study - is administered early in the course of the disease."
508 patients with newly diagnosed, untreated rheumatoid arthritis from The Netherlands were enrolled in the BeSt trial which compared four different treatment strategies in patients with early or recent onset rheumatoid arthritis (RA). 120 patients were randomized to arm 4 and started initial combination therapy with methotrexate and infliximab. At enrolment, all patients had active disease with a disease activity score (DAS) of 4.3, and 64% of patients were classified as rheumatoid factor positive.
Patients received infliximab 3mg/kg plus methotrexate 25mg/week at start of the trial. Dosages of infliximab were altered in a responsive manner according to the DAS throughout the trial.
Disease progression over the course of the trial was ascertained by including the Health Assessment Questionairre (HAQ) as measure for daily functioning, and the van der Heijde modification of the Sharp score (SHS) to assess damage on hand and feet x-rays at initiation of the trial and at 4 years.
The lowest SHS was reported in patients who had reached a stable DAS of <1.6 or clinical remission. Predictably, the highest rate of SHS progression was reported in patients who had failed on the combination of methotrexate and infliximab.
The patients who had reached drug-free remission,had had active RA at baseline (DAS 4.1), 45% were rheumatoid factor positive and 74% had pre-existing erosions.
Of the 120 patients treated with initial methotrexate and infliximab, 30 patients failed on that therapy and proceeded to next pre-specified treatment steps.
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