IPF Protein Treatment Is Tolerable in the Long Term
Results of a phase 2 double-blind, randomized controlled trial had shown that individuals with idiopathic pulmonary fibrosis (IPF) who took PRM-151 experienced a significantly reduced decline in percentage of predicted forced vital capacity as well as a stabilized 6-minute walking distance compared with placebo over a 28-week period. Now, the 76-week results of an open-label extension study show that the effects remain in the long term.
To determine the long-term safety and tolerability of the recombinant human pentraxin 2 protein, the researchers administered PRM-151 in 28-week cycles to the participants who had completed the original 28-week, double-blind study.
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On days 1, 3, and 5 in the first week of each cycle, participants received loading doses of 10 mg/kg by 60-minute intravenous infusions. They then received 1 infusion of 10 mg/kg every 4 weeks thereafter.
Of the 116 participants who had completed the double-blind treatment period, 111 participated in the open-label extension study. In all, 74 participants continued with PRM-151 treatment and 37 switched from placebo to PRM-151. Of the 111 participants, 84 received concomitant IPF therapy (pirfenidone, n = 55, or nintedanib, n = 29).
The participants who continued with PRM-151 experienced a persistent treatment effect. From baseline to week 52, these participants had a decline of -3.6% per year in percentage of predicted forced vital capacity and of -10.5 meters per year in 6-minute walking distance.
The participants who switched from placebo in the double-blind study to PRM-151 in the extension study also experienced a reduction in the decline of their predicted forced vital capacity and 6-minute walking distance, compared with the slopes for placebo.
The researchers measured for adverse events up to week 76 and determined that such events were consistent with long-term IPF sequelae. In all, 31 participants had a serious adverse event, 21 participants had a severe adverse event, and 2 participants had a life-threatening adverse event.
“Long-term treatment with PRM-151 was well tolerated, and the effects on percentage of predicted forced vital capacity and 6-minute walking distance were persistent on continuation and positive in patients who crossed over from placebo,” the researchers concluded. “These findings support further study of PRM-151 in larger populations of patients with IPF.”
—Colleen Murphy
Reference:
Raghu G, van den Blink B, Hamblin MJ, et al. Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study. Lancet Respir Med. 2019;7(8):657-664. doi:10.1016/S2213-2600(19)30172-9.