Tapering versus Steady-state Methotrexate in Combination with Tocilizumab for Rheumatoid Arthritis: a Randomised, Double-blind Trial
Methotrexate (MTX) tapering in patients with active, severe RA receiving intravenous tocilizumab (TCZ) was non-inferior to continuing stable MTX doses in maintaining a good/moderate EULAR response.
Although MTX and bDMARD combination therapy may produce better response rates than bDMARD monotherapy, one third of patients discontinue or are non-compliant with MTX due to preference or toxicity. This randomised, non-inferiority study investigated the efficacy and tolerability of MTX tapering and maintaining stable MTX doses combined with TCZ.
Patients were given open-label TCZ and MTX combination therapy and at 6 months, they were randomised equally to receive tapered or stable MTX doses. MTX tapering was gradual, with MTX doses reaching 0 mg by 12 months. If a disease flare occurred during tapering, MTX doses were increased stepwise until the patient reached recovery and no further tapering was completed. Patient DAS28 scores were assessed monthly and EULAR/ACR responses compared from 6 to 15 months.
A significantly greater number of patients given tapered MTX maintained a good/moderate EULAR response at 15 months compared with those receiving stable MTX doses. There was little difference in DAS28 scores between both treatment groups at 15 and 18 months.
The authors of the study suggest that the data could increase the number of treatment strategies available to patients with active, severe RA thus allowing for more personalised, tailored therapy for patients with RA.