Ann Rheum Dis: Nidanib's safety and tolerance for systemic sclerosis-related interstitiotic pulmonary disease.

Nidanib is a drug used to treat idiotic pulmonary fibrosis.
study describes the safety and tolerance of Nidanib in systemic sclerosis-associated interstitiotic pulmonary disease (SSc-ILD), as well as dose adjustment for adverse events.
in the SENSCIS trial, SSc-ILD patients were randomly divided into two groups and treated with 150 mg nidanib (twice a day) or a placebo.
to control adverse events, the treatment can be stopped or the dose reduced to 100 mg (twice daily).
assessed adverse events and dose adjustments over a 52-week period.
results were as follows: a total of 576 patients were treated with nidanib (n=288) or placebo (n=288).
most common adverse events were diarrhea, which occurred in 75.7 per cent of patients in the Nidanib group and 31.6 per cent in the placebo group, respectively.
6.9 percent of patients in the Nidanib group and 0.3 percent in the placebo group had permanent suspension due to diarrhea, respectively.
48.3% and 12.2% of patients in the nidanib group and 12.2% of patients in the nidanib group had had a reduction and/or suspension of the drug, respectively, and 16.0% and 8.7% of the patients had been permanently suspended due to adverse events.
were similar to Nidanib-related adverse events in different age, gender, race, and weight subgroups.
the dose was adjusted anyway, the rate of decrease in forced lung capacity was similar in patients in the Nidanib group.
result, nidanib's adverse event characteristics in SSc-ILD patients are consistent with safety and tolerance in idynapathic pulmonary fibrosis.
dose adjustment is important to minimize the effects of adverse events and to help patients continue treatment.
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