76 CHAPTER 4 corticosteroid use or contraindications for their use, and co-morbidities that would decrease patients’ life span. After inclusion, patients were randomized to receive 1-2 intramuscular injections (depending on the response to the first injection) of 100 mg of dexamethasone or placebo at baseline and at 6 weeks [47]. Eighty-three patients were recruited and randomized to active treatment (n=42) vs. placebo (n=41). The primary endpoint was a 50% reduction of antibodies or normalization after 6 months of treatment. The secondary outcome of this trial was RA development 5 years after treatment, based on the Disease Activity Score of 28 joints (DAS28) and the fulfilment of ACR criteria for classification. Although the primary endpoint was not reached (in each group only one patient reached the primary endpoint), the study did demonstrate a substantial reduction of ACPA (22% reduction in treatment group vs. 3% increase in placebo group) and, to a lesser extent, IgM-RF (14% reduction in treatment group vs. 1% increase in placebo group) after 1 month. ACPA reduction persisted for up to six months (13% reduction in treatment group vs. 12% increase in placebo group at 3 months, 8% reduction in treatment group vs. 2% increase in placebo group at 6 months), and IgM-RF reduction persisted up to three months (6% reduction in treatment group vs. 6% increase in placebo group), but neither ACPA nor IgM-RF reduction was associated with prevention or delayed onset of RA. The median follow-up time was 26 months, and no significant difference in RA development was observed in the two groups (20% in dexamethasone group, 21% in placebo group). Also, no significant difference in the median DAS28 score was found between the treatment (2.9; IQR 2.4-4.2) and placebo (3.7, IQR 3.2-4.1) groups [48]. csDMARDs Methotrexate Methotrexate has been the cornerstone of RA treatment for decades [41] and rheumatologists have ample experience with this drug, which has a favorable efficacy and safety profile. Consequently, it is not surprising that interventions with this csDMARD have been performed in the early and preclinical phases of the disease as well. The PRObable rheumatoid arthritis: Methotrexate versus Placebo Treatment (PROMPT) study was not a true prevention trial as it evaluated the efficacy of methotrexate treatment in patients with UA, regardless of their ACPA status. Patients had symptoms for less than 2 years and were also DMARD-free [49]. The patients (110 patients in total; 55 patients in each arm) were randomized to either receive active treatment or placebo regardless of their specific risk for developing RA. Initial treatment was with methotrexate (15 mg/week) and the dosage was increased
RkJQdWJsaXNoZXIy MTk4NDMw