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

摘要

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 (cs DMARD s), 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 cs DMARD s and prednisolone and randomized to double‐blind receipt of infusions of either IFX (the Finnish Rheumatoid Arthritis Combination Therapy Trial [ FIN ‐ RAC o] + IFX ) or placebo ( FIN ‐ RAC o + 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 ‐ RAC o) 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 ‐ RAC o + IFX and 47 in the FIN ‐ RAC o + placebo group. At 10 years, the respective proportions of patients in strict NEO ‐ RAC o remission and in Disease Activity Score using 28 joints remission in the FIN ‐ RAC o + IFX and FIN ‐ RAC o + 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 ‐ RAC o + IFX and 7.3 in the FIN ‐ RAC o + placebo group ( P = 0.34). During the 10‐year follow‐up, 26% of the FIN ‐ RAC o + IFX group and 30% of the FIN ‐ RAC o + 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 cs DMARD s and remission‐targeted strategy, regardless of initial IFX /placebo infusions.