ABSTRACT
High levels of efficacy were demonstrated in randomized controlled trials assessing the efficacy of guselkumab; however, real-life data are lacking. In this retrospective cohort study, we assessed the efficacy and safety of guselkumab in a cohort of psoriasis patients heavily pretreated with biologic agents. Primary efficacy endpoint was the percentage of patients achieving ≥psoriasis area and severity index (PASI) 90 response at week 24. The cohort included 33 patients of mean age 60 ± 13 years. Guselkumab was initiated after a mean of 4.0 ± 1.0 prior biologics failed over a mean period of 7. 4 ± 3.8 years. The mean duration of guselkumab treatment was 9.5 ± 3.7 months; 29 patients completed at least 24 weeks of treatment. At week 24, 22 patients (76%) achieved response of PASI 75 or higher, 18 (62%) achieved PASI 90 or higher, five (17%) PASI 100, and seven (24%) ≤PASI 50. No adverse effects were observed. This study confirms the efficacy and safety of guselkumab in real-world clinical practice, although for a lesser degree compared with clinical trials.
Subject(s)
Antibodies, Monoclonal , Psoriasis , Aged , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , Double-Blind Method , Humans , Middle Aged , Psoriasis/diagnosis , Psoriasis/drug therapy , Retrospective Studies , Severity of Illness Index , Treatment OutcomeABSTRACT
Objective: To determine predictors for cesarean delivery (CD) in pregnancies complicated by preterm premature rupture of membranes (PPROM) with an intention for vaginal delivery.Materials and methods: A retrospective cohort analysis of all singleton, preterm deliveries (24 + 0 to 36 + 6 weeks) following PPROM (2007-2014). Exclusion criteria included: cases intended for CD prior to delivery; short interval from PPROM to delivery (<24 hours); cervical dilatation upon admission ≥4 cm; and major fetal anatomical/chromosomal abnormalities. Potential CD predictors were evaluated by univariate followed by multivariate regression analysis.Results: Overall, 465 deliveries met inclusion criteria. Of them, 53 (11.4%) ended with CD. Women in the CD group delivered at an earlier gestational age (34 versus 35 weeks) with lower birth weights (2115 versus 2386 grams), p < .05 for both. On univariate analysis, smaller cervical dilatation upon admission and prior to delivery, longer PPROM to delivery interval and delivery indication were the only significant determinants associated CD (p < .001 for all). On multivariable regression analysis, only la rger cervical dilatation prior to delivery remained an independent factor for lower rates of CD (aOR 0.15, 95% CI 0.08-0.28, p < .001).Conclusion: Small cervical dilatation prior to delivery is an independent risk factor for CD in pregnancies complicated by PPROM.
