July 08, 2016
1 min read

Acceptable tolerability found with pirfenidone for SSc-associated interstitial lung disease

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Researchers found pirfenidone had an acceptable tolerability profile for the treatment of patients with systemic sclerosis-associated interstitial lung disease and suggested tolerability may improve with longer titration.

Researchers randomly assigned 63 patients with systemic sclerosis-associated interstitial lung disease who were treated with pirfenidone to either a 2-week or 4-week titration period starting at 801 mg per day and finishing at a maintenance dose of 2,403 mg/day. Researchers assessed treatment-emergent adverse events and treatment-emergent serious adverse events.

Dinesh Khanna


Results showed 96.8% of patients experienced treatment-emergent adverse events, which were more commonly reported by patients during the titration period vs. the maintenance period. Similar to treatment of idiopathic pulmonary fibrosis with pirfenidone, the most commonly reported treatment-emergent adverse events included nausea, headache and fatigue and were similar regardless of titration schedule, according to results. Researchers found more patients in the 2-week titration group discontinued treatment due to treatment-emergent adverse events vs. patients in the 4-week titration group, with all discontinuation events occurring more than 3 weeks after reaching the full dose of pirfenidone. Overall, 63.5% of patients received mycophenolate mofetil in addition to pirfenidone, and results showed tolerability did not appear to be affected.

“The LOTUSS was a pilot phase 2 trial that revealed that an anti-fibrotic agent, pirfenidone, has an acceptable tolerability profile in patients with scleroderma-associated lung fibrosis,” Dinesh Khanna, MD, MSc, Frederick G. I. Huetwell Professor of Rheumatology and director of the University of Michigan Scleroderma Program, told Healio.com/Rheumatology. “Tolerability was not affected by concomitant mycophenolate mofetil (MMF). This provides a unique opportunity to assess if combination of immunosuppressive therapy, [and] pirfenidone has greater efficacy compared to monotherapy with pirfenidone or MMF in scleroderma-associated lung fibrosis.” – by Casey Tingle

Disclosure: Khanna reports he is a consultant for Genentech/Roche, EMD Serono, Bayer and BMS; and is the primary investigator for Genentech/Roche, Bayer and BMS.