The anti-CD6 antibody itolizumab provides clinical benefit without lymphopenia in rheumatoid arthritis patients: results from a 6-month, open-label Phase I clinical trial.

Itolizumab is a humanized anti-CD6 monoclonal antibody (mAb) that has previously shown encouraging results, in terms of safety and positive clinical effects, in a 6-week monotherapy clinical trial conducted in rheumatoid arthritis (RA) patients. The current Phase I study evaluated the safety and clinical response for a longer treatment of 12 itolizumab intravenous doses in subjects with active RA despite previous disease-modifying anti-rheumatic drug (DMARD) therapy. Twenty-one subjects were enrolled into four dosage groups (0·1, 0·2, 0·4 and 0·8 mg/kg). Efficacy end-points including American College of Rheumatology (ACR)20, ACR50 and ACR70 response rates and disease activity score in 28 joints (DAS28) were monitored at baseline and at specific time-points during a 10-week follow-up period. Itolizumab was well tolerated up to the highest tested dose. No related serious adverse events were reported and most adverse events were mild. Remarkably, itolizumab treatment did not produce lymphopenia and, therefore, was not associated with infections. All patients achieved a clinical response (ACR20) at least once during the study. Eleven subjects (55%) achieved at least a 20% improvement in ACR just 1 week after the first itolizumab administration. The clinical response was observed from the beginning of the treatment and was sustained during 24 weeks. The efficacy profile of this 12-week treatment was similar to that of the previous study (6-week treatment). These results reinforce the safety profile of itolizumab and provide further evidence on the clinical benefit from the use of this anti-CD6 mAb in RA patients.

[Spontaneous rupture of the esophagus: diagnostic problem in the emergency service]. / Rotura espontánea de esófago: un problema diagnóstico en la urgencia.

We present two case of a spontaneous perforation of the esophagus (Boerhaave's syndrome), they were associated with different symptoms. Both of them the diagnosis was make on the second admission to the emergency service. The Boerhaave's syndrome is potentially lethal, relatively rare and the difficult diagnosis in the initial phases. It's a life threatening condition demanding early diagnosis and rapid aggressive management to prevent fulminant death.

[Congenital anomalies of the first branchial cleft. Retrospective study]. / Anomalías congénitas de primera hendidura branquial: estudio retrospectivo.

Anomalies of the first branchial cleft are occasional problems putting up diagnostic and therapeutic difficulties, because the imperfect settlement of reminders of this cleft, which can appear as cysts or branchial fistula, among patients of any age. Though there are several recommended classifications in order to achieve a precious diagnosis and a total surgical removal, sometimes is laborious to correlate the clinical and the histological findings. We report a sequence of congenital periauricular anomalies operated in our Department during a ten-years-term and compare our findings of those quoted after the literature series.

[Thyroglossal cyst: retrospective study of 58 cases. Results of the Sistrunk operation]. / Quiste tirogloso: estudio retrospectivo de 58 casos. Resultados de la operación de Sistrunk.

Cysts of the thyroglossal duct are one of the most common causes of benign neck masses. They generally occur in young patients and are caused by a defect in thyroglossal duct closure, which sometimes is in close contact with the hyoid. Often several tracts are present. The most effective surgical procedure was originally described by Sistrunk in 1920 and modified in 1928. This technique is based on the removal of the central portion of the hyoid bone. This procedure has successfully reduced the number of recurrences compared to local excision of the cyst. A retrospective review was made of 58 cases to evaluate surgical results, especially recurrence rate, in relation to the resection or preservation of the hyoid bone. Results were compared with published series.