The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study.

BACKGROUND: Treatment goals for patients with systemic lupus erythematosus (SLE) include minimising disease activity and reducing the risk of flares. Although belimumab is effective at reducing disease activity and risk of severe flares, it was previously unknown what the clinical effects were upon treatment discontinuation. The objective of this study was to assess the impact of temporary withdrawal of intravenous (IV) belimumab in patients with SLE. METHODS: This multicentre, open-label, non-randomised, 52-week study (GSK Study BEL116027; NCT02119156) recruited patients with SLE and stable low disease activity, of whom those on belimumab 10 mg/kg IV plus standard therapy either discontinued belimumab for 24 weeks and then restarted belimumab 10 mg/kg IV every 4 weeks (q4w) for 28 weeks (treatment holiday [TH] group), or continued on belimumab 10 mg/kg IV plus standard therapy q4w for 52 weeks (treatment continuation [TC] group). The primary endpoint was median time to first Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) Flare Index flare. Secondary and other endpoints included rate of any flare, time to severe flare, time to renal flare and rebound (SELENA-SLEDAI score exceeding parent study baseline). Data on rebound phenomenon in patients with any disease level of SLE who had permanently withdrawn from further belimumab treatment (long-term discontinuation group [LTD]) were also assessed. Safety was assessed. RESULTS: The primary endpoint was not evaluable in the TH (n = 12) and TC (n = 29) groups as fewer than half of patients flared. Unadjusted flare rates per patient-year were 1.0 during treatment discontinuation and 0.3 during treatment restart (0.6 overall) in the TH group and 0.6 in the TC group; there were no severe or renal flares. No TH patients rebounded; 2 (6.9%) TC patients rebounded; 2 (5.1%) patients in the LTD group rebounded. There were no new safety signals. CONCLUSIONS: Twenty-four-week belimumab discontinuation did not appear to increase the risk of flares or rebound in patients with low SLE disease activity; flare rates were low in both groups. Further studies may help to fully determine the effect of belimumab discontinuation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02119156 . Registered on April 21, 2014.

Risk Evaluation of Endoscopic Retrograde Cholangiopancreatography-Related Contrast Media Allergic-Like Reaction: A Single Centre Experience.

Background and Aims. Few cases of endoscopic retrograde cholangiopancreatography- (ERCP-) related contrast media (CM) adverse reactions have been reported in the current literature. There is a lack of standardisation in practice regarding premedication prophylaxis for at-risk patients undergoing ERCP and there are few data to guide the practitioners. Our goal is to evaluate the risk of CM adverse reaction in a group of patients with a past history of allergic-like reaction to iodine product undergoing ERCP. Methods. A retrospective chart review study was performed of patients who underwent ERCP at our single centre from January 2010 to December 2015. Results. 2295 ERCPs were performed among 1766 patients. No anaphylactoid or severe adverse reaction occurred. One (0.04%) ERCP-related CM benign reaction was reported in a patient known for penicillin allergy. Among 127 ERCPs performed on patients with a prior adverse reaction to iodine, 121 procedures were done without and 6 with a premedication prophylaxis. In both groups, no ERCP-related CM reaction occurred. Conclusions. To our knowledge, we report the largest cohort of iodine allergic patients undergoing ERCP ever published. These results suggest that ERCP-related CM adverse reactions are very rare even among patients at risk for CM reaction.

Factors affecting return to work following facial trauma.

BACKGROUND: Injury has a major impact on work absence. The aim of this study was to document the rate and timeframe at which facially injured patients return to work, and to identify the preinjury and injury-related factors that affect return to employment. METHODS: A prospective cohort study was undertaken of facially injured patients over a 12-month period. The primary measure of outcome assessed was time taken (in days) to return to employment. Sixteen preinjury and injury-related variables were identified to analyze their effect on return to work. Both univariate and multivariate Cox regression analyses were performed on each variable. RESULTS: Seven hundred fourteen adult, facially injured trauma patients presented in the 12-month period. Two hundred thirteen patients (30 percent) were excluded because of being unemployed or retired, and 21 patients did not return to work. The remaining 480 patients were included in the study. The median time to return to work was 15 days (mean, 19 days). Seven preinjury and injury-related variables were identified that significantly affected return to employment: sex, operation status, income band, cause, work-related accident, concomitant injuries, and number of facial fractures. CONCLUSIONS: As a cohort, facially injured patients have a relatively high rate of return to work (80 percent at 30 days, 96 percent at 12 months). Clinicians should identify those patients at risk of having a poor return to employment outcome and provide appropriate support and referral to allied health services. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.