Roflumilast Cream vs Vehicle Cream and Chronic Plaque Psoriasis—Reply

In Reply In response to the Letter by Mr Smith and colleagues, we agree that studies of representative patient populations are important, but we challenge the notion that our results cannot be applied to a general population of individuals with psoriasis because only 36.3% of patients were female. The consideration when assessing the applicability of the results should be whether the sample size is sufficient to make precise determinations of efficacy and safety rather than if the percentage of females in the trials match the general psoriasis population, although the latter is also important. Our study included a sizable representation of 320 female patients with psoriasis (36.3%). Indeed, the corresponding author of the Letter to which we are responding was coauthor of a recent large psoriasis study in which only 31% to 32% of patients were female. Additionally, in the study cited by Smith and colleagues that assessed sex differences in severity of psoriasis, 40% of the patients were female, and the severity of psoriasis in females as assessed by the Psoriasis Area and Severity Index (PASI) scores was lower than males. This study also reported that a lower percentage of female patients sought specialist care for their psoriasis. In a pooled analysis of the female subgroup of patients in DERMIS-1 and DERMIS-2, Investigator Global Assessment success at week 8 was achieved in 38.0% of females treated with 0.3% roflumilast cream vs 5.2% in the vehicle group (P 

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Febbraio 2023

Abstract 23: Effect Of Intravenous Tirofiban Vs Placebo On First-pass Effect In Endovascular Stroke Thrombectomy: Insights From The Rescue Bt Randomized Clinical Trial

Stroke, Volume 54, Issue Suppl_1, Page A23-A23, February 1, 2023. Background:First-pass effect (FPE) defined as a complete or near-complete reperfusion achieved after a single thrombectomy pass is predictive of favorable outcome in acute ischemic stroke (AIS) patients with large vessel occlusion. It remains uncertain whether intravenous tirofiban is effective to improve the rate of FPE in anterior circulation strokes.Methods:RESCUE-BT (A randomized controlled trial of intravenous tirofiban or placebo prior to endovascular thrombectomy for large vessel occlusion stroke) enrolled 948 patients with proximal intracranial large vessel occlusion presenting within 24 hours of time last known well to receive intravenous either tirofiban or placebo before endovascular thrombectomy. Patients who did not treated with endovascular thrombectomy were excluded from this cohort. The endpoint was FPE, which defined by extended thrombolysis in cerebral infarction (eTICI) scale 2b, 2c or 3 after the first pass. A modified Poisson regression analysis was performed to assess the association between intravenous tirofiban treatment and FPE.Results:Twenty-two patients were excluded for not treating with endovascular thrombectomy. The remaining 926 patients were included (mean age, 66 years; 380 [41.0%] women), with 450 in the tirofiban and 476 in the placebo group, respectively. Among them, an FPE was achieved in 141 patients (31.3%) of the tirofiban group vs 114 patients (23.9%) of the placebo group. The adjusted risk ratio for FPE with tirofiban vs placebo was 1.24 (95%CI, 1.02-1.52).Conclusions:Treatment with intravenous tirofiban before endovascular thrombectomy significantly increased the incidence of FPE in acute ischemic stroke patients with large vessel occlusion presenting within 24 hours of time last known well.

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Febbraio 2023