GSK said today that a large phase 3 trial of a once highly-promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, it would not seek regulatory approval for the drug.
The SOLID-TIMI 52 (Stabilisation Of pLaques usIng Darapladib – Thrombolysis In Myocardial Infarction 52) trial randomized more than 13,000 patients within 30 days of an acute coronary syndrome to receive either placebo or darapladib, an anti-inflammatory drug designed to stabilize atherosclerotic plaques. GSK reported today that the drug did not significantly reduce major coronary events. The full results of the trial will be presented at a future scientific meeting.
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Psoriasis patients who take TNF inhibitors have a significant reduction in the risk for myocardial infarction (MI), according to a retrospective cohort study published in Archives of Dermatology. Although previous research suggested that the anti-inflammatory effects of methotrexate, an older therapy, may be beneficial in this population, the cardiovascular effects of TNF inhibitors had not been well studied.
Researchers identified 8845 patients who were diagnosed with psoriasis or psoriatric arthritis within the Kaiser Permanente Southern California health plan. After a median of 4.3 years of observation, the overall rate of MI was 5.21 per 1000 patient-years.
- In the 1673 patients who received a TNF inhibitor (etanercept, infliximab, or adalimumab), the MI rate was 3.05 per 1000 patient-years.
- In the 2097 patients who received oral therapy or phototherapy, the MI rate was 3.85 per 1000 patient-years.
- In the 5075 patients who received topical therapy, the MI rate was 6.73 per 1000 patient-years.
TNF inhibitors and oral therapy/phototherapy were each superior to topical therapy, but the difference between TNF inhibitors and oral therapy/phototherapy was not significant. Compared with topical agents, TNF inhibitors and oral agents/phototherapy had hazard ratios (adjusted for other risk factors) of 0.50 and 0.54, respectively.
The authors write, “This is the first large scale retrospective cohort study to show that the use of TNF inhibitors for psoriasis is associated with a clinically and statistically significant reduction in MI risk and incident rate compared with psoriatic patients treated with topical agents.” However, they note that “prospective studies are needed and warranted to determine whether the use of TNF inhibitors may reduce the risk of major adverse cardiovascular events in patients with systemic inflammatory conditions.”
Click here to read the press release from Archives of Dermatology…