Optimizing DMARD Therapy in Rheumatoid Arthritis Save

A phase IV trial from Spain demonstrates that optimization of therapy by lessening biological DMARDs in rheumatoid arthritis (RA) may be feasible, with a low risk of flare.

The OPTIBIO trial was a randomized, open-label, noninferiority study from five hospitals in Spain, enrolled adult RA patients in sustained remission on stable bDMARD therapy. Patients were randomized 1:1 to standard (continued) care or dose reduction (lowering dose or interval). The primary outcome was joint flare at 12 months. 

There were 39 flares amongst 195 patients (optimization: 22.7%, control: 17.2%), difference of -5.5%; P = 0.33). At baseline these patients had a mean SDAI ~3, 96% had SJC <1 DAS, and they had a mean DAS-CRP below 2 (1.7-2) for a median of ~21 months.

Two predictive models were developed: one for flares (AUC: 0.84) based on 3v-DAS28-CRP, VAS pain, erosions, systolic blood pressure, and hemoglobin, and another for sustained remission (AUC: 0.77) including 3v-DAS28-CRP, age, and rheumatoid factor. Adding molecular biomarkers improved AUCs to 0.91 and 0.88, respectively.

bDMARD dose optimization was non-inferior to the continuation of therapy with regard to future flare rates. Predictive of sustained remission may help select patients to ensure the success of less drug in patients in remission.