Automated text message enhanced monitoring versus routine monitoring in early rheumatoid arthritis: a randomized trial

OBJECTIVE:Frequent monitoring of early rheumatoid arthritis (RA) patients is required for achieving good outcomes. We studied the influence of text message (SMS) enhanced monitoring on early RA outcomes.METHODS:We randomized 166 early, disease-modifying antirheumatic drug naive RA patients to SMS-enhanced follow-up or routine care. All patients attended visits at 0, 3, and 6 months, and a follow-up visit at 12 months. Treatment was at the physicians' discretion. The intervention included 13 SMSs during weeks 0-24 with questions concerning medication problems (yes/no) and disease activity (patient global assessment [PGA], scale 0-10). If response SMSs indicated medication problems or PGA exceeded predefined thresholds the patients were contacted. Primary outcome was 6-month Boolean remission (no swollen or tender joints, normal CRP). Quality of life (QOL, Short Form 36) and 28-joint disease activity scores (DAS28) were assessed.RESULTS:Six and 12-month follow-up data were available for 162 and 157 patients. In the intervention group, 47% (38/82) of the patients reported medication problems and 49% (40/82) of the patients reported SMS-PGAs above the alarm limit. Remission rates in the intervention and control groups were 51% and 42% at 6 months (p=0.34); and 57% and 43% at 12 months (p=0.17). The respective DAS28 scores were 1.92±1.12 and 2.22±1.11 at 6 months (p=0.09); and 1.79±0.91 and 2.08±1.22 at 12 months (p=0.28). No differences in QOL were observed.CONCLUSION:The study failed the primary outcome despite a trend favoring the intervention group. This may be explained by the notably high overall remission rates. This article is protected by copyright. All rights reserved.</p

Early Targeted Combination Treatment With Conventional Synthetic Disease-Modifying Antirheumatic Drugs and Long-Term Outcomes in Rheumatoid Arthritis : Ten-Year Follow-Up Results of a Randomized Clinical Trial

Objective The short-term outcomes of remission-targeted treatments of rheumatoid arthritis (RA) are well-established, but the long-term success of such strategies is speculative, as is the role of early add-on biologics. We assessed the 10-year outcomes of patients with early RA treated with initial remission-targeted triple combination of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 7.5-mg prednisolone, and additional infliximab (IFX) or placebo infusions. Methods Ninety-nine patients with early, DMARD-naive RA were treated with a triple combination of csDMARDs and prednisolone and randomized to double-blind receipt of infusions of either IFX (the Finnish Rheumatoid Arthritis Combination Therapy Trial [FIN-RACo] + IFX) or placebo (FIN-RACo + placebo) during the first 6 months. After 2 years, the treatment strategies became unrestricted, but the treatment goal was strict remission in the TNF-Blocking Therapy in Combination With Disease-Modifying Antirheumatic Drugs in Early Rheumatoid Arthritis (NEO-RACo) study. At 10 years, the clinical and radiographic outcomes and the drug treatments used between 5 and 10 years were assessed. Results Ninety patients (91%) were followed after 2 years, 43 in the FIN-RACo + IFX and 47 in the FIN-RACo + placebo group. At 10 years, the respective proportions of patients in strict NEO-RACo remission and in Disease Activity Score using 28 joints remission in the FIN-RACo + IFX and FIN-RACo + placebo groups were 46% and 38% (P = 0.46) and 82% and 72% (P = 0.29), respectively. The mean total Sharp/van der Heijde score was 9.8 in the FIN-RACo + IFX and 7.3 in the FIN-RACo + placebo group (P = 0.34). During the 10-year follow-up, 26% of the FIN-RACo + IFX group and 30% of the FIN-RACo + placebo group had received biologics (P = 0.74). Conclusion In early RA, excellent results can be maintained up until 10 years in most patients treated with initial combination csDMARDs and remission-targeted strategy, regardless of initial IFX/placebo infusions.Peer reviewe

Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis:48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial

Background: The optimal first-line treatment in early rheumatoid arthritis (RA) is debated. We compared clinical and radiographic outcomes of active conventional therapy with each of three biological treatments with different modes of action. Methods: Investigator-initiated, randomised, blinded-assessor study. Patients with treatment-naïve early RA with moderate-severe disease activity were randomised 1:1:1:1 to methotrexate combined with (1) active conventional therapy: oral prednisolone (tapered quickly, discontinued at week 36) or sulfasalazine, hydroxychloroquine and intra-articular glucocorticoid injections in swollen joints; (2) certolizumab pegol; (3) abatacept or (4) tocilizumab. Coprimary endpoints were week 48 Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) and change in radiographic van der Heijde-modified Sharp Score, estimated using logistic regression and analysis of covariance, adjusted for sex, anticitrullinated protein antibody status and country. Bonferroni's and Dunnet's procedures adjusted for multiple testing (significance level: 0.025). Results: Eight hundred and twelve patients were randomised. Adjusted CDAI remission rates at week 48 were: 59.3% (abatacept), 52.3% (certolizumab), 51.9% (tocilizumab) and 39.2% (active conventional therapy). Compared with active conventional therapy, CDAI remission rates were significantly higher for abatacept (adjusted difference +20.1%, p<0.001) and certolizumab (+13.1%, p=0.021), but not for tocilizumab (+12.7%, p=0.030). Key secondary clinical outcomes were consistently better in biological groups. Radiographic progression was low, without group differences. The proportions of patients with serious adverse events were abatacept, 8.3%; certolizumab, 12.4%; tocilizumab, 9.2%; and active conventional therapy, 10.7%. Conclusions: Compared with active conventional therapy, clinical remission rates were superior for abatacept and certolizumab pegol, but not for tocilizumab. Radiographic progression was low and similar between treatments. Trial registration number: NCT01491815