Introduction: Patients with rheumatoid arthritis (RA) are at an increased risk of developing malignancies, but it is unclear whether this increased risk is the result of disease pathobiology or immunosuppressant treatments for RA. This analysis evaluated the potential risk of malignancy in patients with RA treated with rituximab (MabThera Ò /Rituxan Ò) a CD20? B-cell depleting agent manufactured by F. Hoffmann-La Roche Ltd. Methods: Malignancy rates were obtained from the rituximab global company safety database for adverse event reporting and from the rituximab global clinical trial program for RA consisting of eight randomized clinical trials, two long-term open-label extensions, and one openlabel prospective study. Global company safety database searches were performed using the standard Medical Dictionary for Regulatory Activities (MedDRA) queries ''Malignant tumors wide'' and ''Skin malignant tumors wide'' up to April 30, 2017. Age-and sex-specific comparator values from the general population were obtained from the US National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database. Results: For the 409,706 patients with RA in the rituximab global company safety database since first market approval in 2006, 1739 cumulative malignant events were reported, with an overall malignancy reporting rate of approximately 4.2 events per 1000 patients. No evidence of increased risk of malignancy, of any organ-specific type, was found following rituximab treatment. The rate of malignancies from rituximab-treated patients in RA clinical trials was 7.4 per 1000 patient-years. This is within the expected range, with no evidence for increased risk over time or with additional rituximab courses.

This study used retrospective chart review and survey data to evaluate: (1) off‐label use of rituximab (MabThera®/Rituxan®) in autoimmune conditions and (2) patients’ receipt and knowledge of the Patient Alert Card (PAC), a risk minimization measure for progressive multifocal leukoencephalopathy (PML) and serious infections. Anonymized patient data were collected from infusion centers in Europe from December 2015 to July 2017. Adults receiving rituximab in the same centers were provided a self‐administered survey. Outcomes included patterns of off‐label rituximab use for nononcology indications, and evaluation of patients’ receipt and knowledge of the PAC and its impact. Of 1012 patients in the retrospective chart review, 70.2% received rituximab for rheumatoid arthritis or granulomatosis with polyangiitis/microscopic polyangiitis, and 29.8% received rituximab off label. Among 524 survey participants, 32.8% reported receiving the PAC, 59.3% reported not receiving the PAC and 7.9% did not know whether they received the PAC. A total of 72.4% of patients reported that they were unaware that some patients receiving rituximab experience PML. A higher proportion of PAC recipients identified PML as a potential risk of rituximab than nonrecipients (37.8% vs 19.9%); 58.3% of PAC recipients had poor awareness of PML. Most PAC recipients (90.0%) and nonrecipients (85.5%) correctly answered that they should seek medical attention for infection symptoms. In conclusion, approximately 30% of patients received off‐label rituximab. Most patients reported not receiving the PAC or having knowledge of PML but demonstrated understanding of the recommended action in the event of infection symptoms, regardless of PAC receipt.

27 cardiac patients with different types of arrhythmias were treated in the coronary care unit with tiapamil administered by intravenous infusion. Special attention was given to determining the antiarrhythmic effects in patients with acute coronary insufficiency. In the group of 15 patients with ventricular extrasystoles (VEs; Lown classification III-V), 9 patients had acute myocardial infarction and 1 patient had coronary artery disease. In the group with supraventricular extrasystoles (6 cases), 1 patient had experienced anterior infarction. The third group comprised 6 patients with combined ventricular (Lown V) and supraventricular extrasystoles. In 1 case, the arrhythmia was due to acute anterior infarction, 2 patients had experienced reinfarction and one patient had crescendo angina pectoris. ECG and hemodynamics were monitored continuously before, during and for 20 h following therapy. In patients with VEs alone, the median frequency fell from 612 to 459/h at the third hour of infusion. The median VE/sinus beat quotient decreased from 0.125 to 0.0108 (p < 0.01) in the third hour of treatment, and increased to 0.1029 after the completion of therapy. VE suppression was particularly marked in the 10 patients with coronary artery disease, 7 of these demonstrating a reduction by over 90%. Similar results were obtained in patients with supraventricular arrhythmias and mixed forms.The preliminary results show that tiapamil may be an effective antiarrhythmic agent in supraventricular and particularly in ventricular extrasystoles, and that its spectrum of antiarrhythmic action merits detailed investigation in larger numbers of patients.

Introduction:The aim of this work was to assess the impact of prolonged low immunoglobulin (IgG or IgM) serum concentrations on the potential cumulative serious infection (SI) risk in pediatric patients following rituximab treatment for granulomatosis with polyangiitis or microscopic polyangiitis (GPA/ MPA) in PePRS. Methods: Patients aged C 2 to\ 18 years received four weekly intravenous rituximab infusions of 375 mg/m 2 and concomitant glucocorticoid taper. After 6 months, patients could receive further rituximab and/or other immunosuppressants per investigator discretion. Immunoglobulin levels and SIs were assessed throughout the 4.5-year observation period. Prolonged low IgG or IgM was defined as below the lower limit of normal age-specific reference range for C 4 months.

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