Novel Treatment May Be Safe and Effective for Treating IPF
Pamrevlumab may be a novel, safe, and effective treatment for patients with idiopathic pulmonary fibrosis (IPF), according to results of the phase 2 PRAISE trial.
To evaluate the ability of pamrevlumab—a fully recombinant human monoclonal antibody against connective tissue growth factor (CTGF)—to slow, stop, or reverse progression of IPF, the researchers conducted the PRAISE trial at 39 medical centers in 7 countries.
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Between August 17, 2013, and July 21, 2017, 103 patients with IPF and percentage of predicted forced vital capacity (FVC) of 55% or greater were randomly assigned to receive either intravenous infusion of pamrevlumab, 30 mg/kg (n=50), or placebo (n=53) every 3 weeks over 48 weeks (16 infusions). However, due to enrollment error, 2 patients from the placebo group were excluded from the intention-to-treat population for the efficacy analyses.
The primary efficacy outcome was change in percentage of predicted FVC from baseline to week 48. And at week 48, pamrevlumab had reduced the decline in percentage of predicted FVC by 60.3%. While the mean change from baseline to week 48 was −2.9% with pamrevlumab, the mean change over the same timeframe was −7.2% with placebo.
A key secondary efficacy outcome was disease progression—defined as a decline from baseline in percentage of predicted FVC of 10% or greater, or mortality—at week 48. And at week 48, a smaller proportion of patients from the pamrevlumab group had experienced disease progression (10.0%) than those in the placebo group (31.4%).
All patients from the pamrevlumab group had received at least one dose of the study drug and were analyzed for safety. According to this safety analysis, pamrevlumab was well tolerated and had a safety profile similar to that of placebo.
Overall, 24% of patients from the pamrevlumab group and 15% from the placebo group had experienced a treatment-emergent serious adverse event. Of the 12 patients from the pamrevlumab group to experience such an event, 3 had discontinued treatment. And of the 8 patients from the placebo group who had a treatment-emergent serious adverse event, 7 had discontinued treatment.
“Pamrevlumab attenuated progression of idiopathic pulmonary fibrosis and was well tolerated,” the study authors concluded. “Now in phase 3 development, pamrevlumab shows promise as a novel, safe, and effective treatment for idiopathic pulmonary fibrosis.”
—Colleen Murphy
Reference:
Richeldi L, Fernández Pérez ER, Costabel U, et al. Pamrevlumab, an anti-connective tissue growth factor therapy, for idiopathic pulmonary fibrosis (PRAISE): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2020;8(1):25-33. https://doi.org/10.1016/S2213-2600(19)30262-0.