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Background While no adverse developmental outcomes were observed in preclinical animal studies, limited data exist regarding effects of ustekinumab on human pregnancies. Previously, no data have been reported for women treated with ustekinumab in inflammatory bowel disease (IBD) clinical trials and corresponding pregnancy outcomes. Here, we present pregnancy outcomes from IBD clinical trials, incorporating 5 years of treatment in Crohn’s disease (CD) and 2 in ulcerative colitis (UC). Methods All patients in the clinical trials agreed to use adequate birth control and were discontinued from treatment upon pregnancy confirmation. Nonetheless, 39 pregnancies occurred with maternal ustekinumab exposure from 4 CD and 1 UC study. Maternal and neonatal outcomes and data are presented with summary statistics, where available. Results Of 1289 women who received ≥1 dose of ustekinumab, 39 maternal pregnancies with outcomes were reported (pregnancy cohort). Median maternal age was 28.0 years and median duration of ustekinumab treatment before pregnancy was 63.7 weeks with the last dose of ustekinumab administered prior to or during the first trimester (terminal half-life of ~3 weeks). Outcomes for the 39 pregnancies were: 26 live births (all normal newborns), 8 spontaneous abortions, and 5 elective abortions. No congenital anomalies were reported among normal newborns and no safety signals emerged with neonatal outcomes. Conclusions Based on this series of 39 pregnancies with outcomes from IBD clinical trials, mothers treated with ustekinumab (limited to up to the first trimester) did not demonstrate a risk of negative outcomes. More data are needed to characterize the safety profile of ustekinumab use during pregnancy.

Background We sought to determine the outcomes in patients presenting with venous thoracic outlet syndrome. Methods Prospectively collected data from 67 patients between October 2003 and December 2007. The average age was 31 years (range, 16–54); the 37 males and 30 females presented on average 9.2 months (range, 1 month–6 years) after acute thrombosis. Four treatment algorithms were utilized. Results In group 1, 3 patients presented with acute occlusion and received tissue plasminogen activator (tPA) and immediate first rib resection with scalenectomy (FRRS). One vein rethrombosed and was treated by intravenous tPA postoperatively. In group 2, 39 patients presented with stenotic subclavian veins an average of 22 weeks after their initial thrombosis, all of whom underwent FRRS followed by a venogram 2 weeks postoperatively: 25 had a tight stenosis and underwent venoplasty with anticoagulation; 13 had patent, nonstenotic subclavian veins, and 1 patient required tPA and venoplasty owing to rethrombosis. Two patients had their subclavian vein thrombose after venoplasty and were treated with anticoagulation, tPA, and venoplasty. In group 3, 11 patients presented with intermittent venous obstruction without thrombosis and underwent FRRS; 3 underwent venograms because of concerns of residual stenosis, 2 of whom required venoplasty postoperatively. Finally, in group 4, 14 patients presented with occluded subclavian veins and underwent FRRS with long-term anticoagulation. Eleven have recanalized at an average of 6 months (range, 2–12). Conclusion Overall, 64 of 67 patients have patent subclavian veins after a median follow-up of 10 months, and all patients are asymptomatic for a success rate of 96%. Tailored treatment algorithms including FRRS, postoperative venograms with or without intervention, and the use of long-term anticoagulation seems to be required in this complicated group of young patients to achieve optimal results.

La resection de la premiere cote et la scalenectomie est un traitement acceptable chez les malades ayant une thrombose de la veine axillo-sous-claviere qui ont repondu au traitement thrombolytique et demontre une permeabilite de la veine sous-claviere. Cependant, le traitement des malades se presentant avec une occlusion chronique de la veine sous-claviere est controverse. Nous presentons quatre malades de ce type qui ont eu une resection de la premiere cote et une scalenectomie et dont la veine sous-claviere s'est spontanement recanalisee dans l'annee suivant l'intervention, alors qu'ils etaient anticoagules, ainsi que le protocole d'ultrasons utilise dans notre institution pour identifier une telle recanalisation. L'âge moyen de ces malades etait de 20 ans (extremes 17 et 23 ans). Trois etaient de sexe masculin et une de sexe feminin. L'intervalle de temps moyen entre l'intervention et la thrombose etait de 25 semaines (extremes 12 et 34 semaines). Tous les malades etaient asymptomatiques et ont eu une resection de la premiere cote et une scalenectomie par voie axillaire, en incisant le tendon du muscle sous-clavier. Tous ont eu un traitement post-operatoire par warfarine et ont ete surveilles par echographie-Doppler. Chez chacun de ces quatre malades, la veine sous-claviere s'est recanalisee par la suite apres une moyenne de 7 mois (extremes deux et 11 mois) et l'anticoagulation a ete arretee. La permeabilite de la veine sous-claviere qui en est resultee a ete correlee avec l'amelioration des symptomes chez chacun des quatre malades. Tous les malades etaient asymptomatiques au cours de la periode de suivi post-operatoire a une moyenne de 14 mois (extremes deux et 33 mois). En conclusion, certains malades ayant une occlusion de la veine sous-claviere peuvent etre traites agressivement par resection de la premiere cote et scalenectomie ainsi que par anticoagulation, entrainant la recanalisation et la reouverture de la veine au cours du temps. Ce traitement est correle avec l'amelioration des symptomes.

La reseccion de la primera costilla y la escalenectomia es un tratamiento satisfactorio en pacientes con trombosis venosa axilo-subclavia que han respondido al tratamiento trombolitico y para los que se ha demostrado la permeabilidad de la vena subclavia. Sin embargo, el tratamiento de pacientes que presentan una oclusion cronica de esta vena es motivo de controversia. Presentamos a cuatro pacientes con estas caracteristicas que se sometieron a la reseccion de la primera costilla y a una escalenectomia y cuya vena subclavia se permeabilizo espontaneamente en el primer ano despues de la cirugia mientras recibian tratamiento anticoagulante, al igual que el protocolo ecografico usado en nuestro hospital para identificar la repermeabilizacion de la vena. La edad media de estos pacientes fue de 20 (limites de edad 17-23) anos, tres eran hombres, y el cuarto, una mujer. El intervalo medio de tiempo antes de la cirugia cuando se produjo la trombosis inicial fue de 25 (12-34) semanas. Todos los pacientes se encontraban sintomaticos y se sometieron a la reseccion transaxilar de la primera costilla y a una escalenectomia, prestando atencion al abordaje del tendon subclavio. En el postoperatorio recibieron tratamiento de mantenimiento con warfarina y se sometieron a seguimiento con eco-Doppler. Mas tarde, en los cuatro pacientes despues de una media de 7 (2-11) meses, la vena subclavia se repermeabilizo y la anticoagulacion se interrumpio. La permeabilidad resultante de la vena subclavia se correlaciono con una mejora de los sintomas en los cuatro pacientes. En el periodo de seguimiento postoperatorio, a una media de 14 (2-33) meses los pacientes se encontraban asintomaticos. En conclusion, los pacientes sintomaticos seleccionados con oclusion de la vena subclavia pueden tratarse agresivamente con reseccion de la primera costilla y escalenectomia junto con anticoagulacion que dara lugar a la recanalizacion y apertura de la vena con el tiempo. Este tratamiento se correlaciona con una mejora de los sintomas.