After 12 months of anti-TNF therapy, the median prednisolone dose declined from 6 mg to 2.5 mg, but the decline appeared to be driven by five patients who sharply decreased their dose. Seven patients successfully stopped anti-TNF therapy after improvement occurred, Dr. Campanilho-Marques said.
Serious adverse events occurred 12 times during the year-long study period, including nine allergic reactions and three hospitalizations because of infection. Another 19 mild-to-moderate adverse events took place, which involved 15 infections and three local site reactions and skin rash, which led five patients to discontinue the biologic.
Overall, adverse events occurred at a rate of 13.3/100 patient-years, including 5.2 serious events/100 patient-years. One patient died because of a small bowel perforation that was probably secondary to disease-related damage. There were no malignancies or tuberculosis cases.
In a video interview at the meeting, Dr. Campanilho-Marques discussed the study findings and their implications.
The researchers had no relevant disclosures.