Predictors of Response to Induction Therapy with Ustekinumab in Patients with Ulcerative Colitis: Results from a National Study in Greece.
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Chalakatevaki Konstantina, Kokkotis Georgios, Gazouli Maria, Sakellariou Stratigoula, Vamvakaris Ioannis, Chatzidakis Alexandros, Gerasimatos Gerasimos, Kalogirou Maria, Koustenis Kanellos, Lazou Dimitra, Orfanidou Afroditi, Palatianou Maria, Papathanasiou Evgenia, Psistakis Andreas, Sotiropoulos Christos, Anagnostopoulou Evaggelia, Argyriou Konstantinos, Chatzinikolaou Matina-Lydia, Foteinogiannopoulou Kalliopi, Giouleme Olga, Kapsoritakis Andreas, Karatzas Pantelis, Karmiris Konstantinos, Kiriakos Nikolaos, Koutroubakis Ioannis, Liatsos Christos, Mantaka Aikaterini, Mantzaris Gerasimos, Markopoulos Panagiotis, Michalopoulos Georgios, Michopoulos Spiros, Polymeros Dimitrios, Soufleris Konstantinos, Theocharis Georgios, Theodoropoulou Angeliki, Tsironi Eftychia, Tzouvala Maria, Viazis Nikos, Zacharopoulou Eirini, Zampeli Evanthia, Bamias Giorgos
Аннотация
METHODS: This is a multicenter, prospective cohort study. Clinical response (CR) at week 16 was the primary endpoint, and steroid-free clinical remission (SFCRem) and endoscopic response were the secondary endpoints. Baseline histology, mucosal gene expression, and pharmacokinetics were studied for their effect on response to treatment.
RESULTS: We included 123 patients (mean age = 50.3 years). CR was recorded in 70.8% (75/106), SFCRem in 48% (59/123), endoscopic improvement in 71.4% (40/56), and mucosal healing in 28.6% (16/56). Higher PRO-stool frequency (OR = 0.49, p = 0.027), concomitant use of 5-ASA (OR = 3.69, p = 0.021), platelet number of ≥284 × 109/L (OR = 6.52, p = 0.001) at baseline, and a drop in the total count of platelets by 108/L (OR = 1.23, p = 0.022) at week 8 were independently associated with CR. Elevated trough levels of ustekinumab at week 16 were associated with a higher probability of endoscopic improvement (median difference = 3784 ng/mL, p = 0.013), with an optimal cut-off value of 3500 ng/mL (AUC = 0.82, 95% CI: 0.66-0.96). Increased mucosal mRNA expression for IL-23 (p = 0.007) and IL-23R (p = 0.031) at baseline was associated with increased probability of CR. Higher continuous Geboes scores at baseline were associated with a lower probability of CR (OR = 0.80, p = 0.045), with an optimal cut-off value of 14 (AUC = 0.75, 95% CI: 0.57-0.93).
CONCLUSIONS: Clinical, laboratory, and molecular markers may identify patients with ulcerative colitis who are more likely to respond to ustekinumab.