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【Introduction to Aisra】
Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by cytokines that often affects multiple organs such as the eyes, heart, lungs, etc.
【Typical symptoms】
RA-ILD onset is insidious, in addition to its own joint manifestations, the early pulmonary symptoms are not obvious, only manifested as fatigue, cough, easy to be ignored by patients, with the progression of the disease, gradually appear shortness of breath, exertional dyspnea, chest tightness, restrictive ventilation disorders, diffusion function and hypoxemia, severe impact on daily activities, the need to inhale oxygen to maintain normal breathing, late pulmonary fibrosis and respiratory failure prognosis is poor, and eventually may lead to death
.
【Research Progress】
According to a study published in The Lancet in September, a randomized, double-blind, placebo-controlled Phase 2 study was presented to validate safety, tolerability
, and efficacy in patients with rheumatoid arthritis-associated interstitial lung disease.
The trial screened 123 patients from 231 eligible patients for testing
.
Patients in the pirfenidone group took 3 times a day at 267 mg per day on days 1 to 7 of the trial; On days 8 to 14, take 534 mg 3 times a day; Take 801 mg 3 times a day after day 14 and reach a daily level of
2403 mg.
The trial planned to conduct 11 face-to-face interviews with each patient and a major efficacy assessment at week 52; At weeks 0, 13, 26, 39 and 52, patients are also tested for spirometry and health-related quality of life questionnaires
.
【Result analysis】
Due to the impact of the COVID-19 pandemic in 2020, the trial was terminated
early.
As shown in the figure above, the blue color represents the pifenidone group, decreased by 66 ml; Orange represents the placebo group, down 146 ml
.
As shown in the figure above, the rate of decline in FCV in the pifinidone group (blue) was significantly lower than in the placebo group (orange
).
As shown in the figure above, in the pifinidone and placebo groups, the improvement in pulmonary function changes in patients with different classifications, including UIP (restrictive pulmonary dysfunction) and patients without UIP, was significantly better than in patients of the same type in the placebo group
.
In the analysis of secondary endpoints, the pifenidone group also showed an advantage
over the placebo group.
The most common adverse effects present in treatment are nausea, fatigue, and diarrhea, and these adverse events are usually grade 1 and have no clinical significance
.
Although a total of 5 deaths were reported in the study, including 2 deaths (3%) of 62 patients in the pirfenidone group and 3 deaths (5%) of 60 patients in the placebo group, none were judged to be related
to the study drug.
【Research Conclusion】
The trial showed that pifinidone had good safety tolerance in patients with RA-ILD, and that the combination with drugs for rheumatoid arthritis (e.
【References】
LI Ting, JIANG Zong, TANG Fang, et al.
Solomon J J, Danoff S K, Woodhead F A, et al.
