COMFORT-I
COMFORT-I showed that the JAK-blocking pill ruxolitinib shrank the grossly enlarged spleens of people with myelofibrosis in about four in ten patients, against almost none on placebo, and eased their fatigue, night sweats and itching; it led to the first approved drug for the disease.
Overview
COMFORT-I was a double-blind phase 3 trial in 309 patients with intermediate-2 or high-risk myelofibrosis randomised to ruxolitinib, a selective inhibitor of JAK1 and JAK2, or placebo. The primary endpoint was a spleen volume reduction of 35 percent or more at 24 weeks on MRI; secondary endpoints were durability, symptom burden on a total symptom score and overall survival.
The primary endpoint was reached by 41.9 percent of patients on ruxolitinib against 0.7 percent on placebo, symptom scores improved and later follow-up showed a survival advantage, at the cost of more anaemia and thrombocytopenia early in treatment. Ruxolitinib was approved in the United States in November 2011 for intermediate- and high-risk myelofibrosis, the first drug for the disease. Together with COMFORT-II it is the reason the myeloproliferative neoplasm pages list a JAK inhibitor for spleen and symptom control.
- 41.9 vs 0.7 out of 100 reached this endpoint with Ruxolitinib compared with Placebo; 41.2 more per 100.
- Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- Ruxolitinib: 65 participants; Placebo: 1 participants.
- The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Intermediate-2 or high-risk primary myelofibrosis, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis: twice-daily oral ruxolitinib or placebo, with spleen volume by MRI at 24 weeks as the primary endpoint. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
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