medwireNews: Most patients with rheumatoid arthritis (RA) and stable low disease activity (LDA) can switch from tumor necrosis factor (TNF) inhibitor therapy to tacrolimus as maintenance without experiencing flare-ups, researchers report.
The multicenter, prospective TROPHY study included 114 patients given stable TNF inhibitor plus methotrexate treatment for at least 24 weeks without dose alterations for at least 12 weeks who had stable LDA, defined DAS28-CRP below 3.2 points, for at least 12 weeks.
Other inclusion criteria included a minimal methotrexate dose of 7.5 mg/week, tender and swollen joint counts at or below 5 for at least 4 weeks, and an erythrocyte sedimentation rate (ESR) less than 28 mm/hour or a C-reactive protein (CRP) level below 1.0 mg/dL for 4 weeks before screening.
After being given information on the differences between treatments, 80 patients chose to maintain therapy with a TNF inhibitor (etanercept, adalimumab, or infliximab) plus methotrexate for a further 24 weeks and 34 opted to switch to tacrolimus (1 mg/day orally) plus methotrexate.
At week 24, there was no significant difference between the maintenance and switched arms in the proportion maintaining LDA, at 98.7% and 90.6%, respectively, report Wan-Uk Kim (Catholic University of Korea, Seoul, South Korea) and co-investigators in Arthritis Research & Therapy.
They add that the mean increase in DAS28-CRP between baseline and week 24 was 0.1 points in the maintenance arm and 0.3 points in the switched arm, a nonsignificant difference.
Quality of life, swollen and tender joint counts, and patient and physician global assessments of disease activity did not change significantly over the course of the study in either arm.
However, the least squares (LS) mean increase in serum ESR between baseline and week 24 was significantly smaller in the maintenance arm than in the switched arm (0.00 vs 7.31 mm/hour), as was the LS mean increase in serum CRP (0.08 vs 0.58 mg/dL). Patients in the maintenance arm also had a significantly lower LS mean increase in DAS28-CRP from baseline to week 16 than those in the switched group, at approximately 0.0 versus 0.2 points.
The authors say that both regimens “were well-tolerated,” but people in the maintenance group tended to have a lower rate of treatment-related adverse events (AE) than those in the switched group, at 7.1% versus 20.6%.
Abdominal pain was the most common AE event reported with tacrolimus use, occurring in 11.7% compared with none in the maintenance group. There were three upper respiratory tract infections and one case of oral herpes simplex in the maintenance group and one incident of disseminated tuberculosis in the switched group.
Kim et al conclude: “The TROPHY study provides a new perspective on managing RA patients with stable LDA or those in remission.”
They add: “Switching to [tacrolimus] and discontinuing TNF [inhibitor therapy] is feasible, and most patients maintained LDA over 24 weeks.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group
Arthritis Res Ther 2021; 23: 182