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Objective   The calcineurin inhibitor tacrolimus has been approved in Japan for the treatment of interstitial pneumonia in patients with polymyositis (PM) and dermatomyositis (DM). Post-marketing surveillance was initiated to examine long-term outcomes of immunosuppressive regimens containing tacrolimus in real-world settings.Methods   Observational, prospective, post-marketing surveillance is ongoing in 179 patients with PM/DM-associated interstitial pneumonia initiating treatment with tacrolimus. We report interim findings after 2 years of follow-up. Cumulative overall survival was assessed using Kaplan–Meier analysis. Potential prognostic factors for mortality were assessed by univariate Cox proportional hazards analysis.Results   A total of 170 patients were included in this analysis. At the time of starting treatment with tacrolimus, almost all patients were receiving corticosteroids (98.8%), and cyclophosphamide was additionally used in 42 patients (24.7%). Forty-nine patients (28.8%) discontinued tacrolimus during follow-up, mainly due to loss to follow-up, patient death, and adverse events. Mean ± standard deviation oral corticosteroid dose decreased from 32.4 ± 21.6 mg/day at baseline to 7.6 ± 4.2 mg/day at 2 years. Overall survival at 2 years was 90.3%; corresponding progression-free survival was 62.5%. Factors found to be associated with all-cause mortality included diagnosis of clinically amyopathic DM (Hazard Ratio [HR], 9.04 [95% CI: 1.18–69.51] vs PM), ferritin level 500 to &lt;1500 ng/mL (HR 8.61 [95% CI, 2.51–29.45] vs &lt;500 ng/mL), and presence of anti-melanoma differentiation-associated gene 5 antibodies (HR, 8.16 [95% CI, 1.03–64.47] vs absence).Conclusion   Immunosuppressive regimens containing tacrolimus appear useful for the management of interstitial pneumonia in patients with PM/DM.

the journal of rheumatology/journal of rheumatology

Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan