Tacrolimus, a calcineurin inhibitor, has been licensed to treat interstitial pneumonia (IP) in patients with polymyositis and dermatomyositis (DM). Postmarketing surveillance was begun to investigate the long-term results of tacrolimus-containing immunosuppressive regimens in real-world situations.
Observational, prospective postmarketing monitoring is undertaken in 179 individuals with PM/DM-associated IP who are starting tacrolimus therapy. Researchers provided preliminary findings after two years of follow-up. Kaplan-Meier analysis was used to calculate cumulative overall survival. Univariate Cox proportional hazards analysis was used to evaluate potential prognostic variables for death.
In all, 170 patients were involved in the study. Almost all patients (98.8%) were getting corticosteroids when they began tacrolimus therapy, and cyclophosphamide was also utilized in 42 individuals (24.7%). During follow-up, 49 patients (28.8%) stopped tacrolimus, mostly due to follow-up loss, patient death, and adverse events. The mean (standard deviation) oral corticosteroid dosage fell from 32.4 (21.6) mg/day at baseline to 7.6 (4.2) mg/day after two years. At two years, overall survival was 90.3%, with progression-free survival at 62.5%. Diagnosis of clinically amyopathic DM (hazard ratio [HR] 9.04, 95% CI 1.18-69.51 vs. PM), ferritin level 500 to <1500 ng/mL (HR 8.61, 95% CI 2.51-29.45 vs. <500 ng/mL), and presence of anti-melanoma differentiation-associated gene 5 antibodies (HR 8.16, 95% CI 1.03-64.47 vs. absence) were found to be associated with all-
Immunosuppressive regimens incorporating tacrolimus appear to be effective in treating IP in PM/DM patients.