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Context Denosumab inhibits the receptor activator of nuclear factor κ-Β ligand, an immune system modulator. Safety endpoints including risk for infections were assessed as secondary outcomes in randomized controlled trials (RCTs) of the drug. Objective To assess the risk of serious adverse events of infections (SAEI) in denosumab-treated patients. Data Sources PubMed and Cochrane Central Register of Controlled Trials were searched up to May 27, 2019. Study Selection All RCTs of denosumab (60 mg every 6 months) versus any comparator were included. We excluded trials in cancer patients for prevention of skeletal-related events. Data Extraction Two reviewers independently applied selection criteria and extracted the data. Risk ratios (RR) with 95% confidence intervals (CI) were pooled using a fixed effect model. Sensitivity analysis was based on risk of bias. Data Synthesis Thirty-three studies (22 253 patients) were included. There was a higher incidence of SAEI during denosumab treatment versus any comparator (RR, 1.21; 95% CI, 1.04-1.40; I2 = 0%), mainly of ear, nose, and throat (RR, 2.66; 95% CI, 1.20-5.91) and gastrointestinal origin (RR, 1.43; 95% CI, 1.02-2.01). RR was similar in a sensitivity analysis based on adequate allocation concealment. The RR of any infection (RR, 1.03; 95% CI, 0.99-1.06) and infection-related mortality (RR, 0.50; 95% CI, 0.20-1.23) was comparable between groups. Conclusions A higher incidence of SAEI is demonstrated during treatment with denosumab in an osteoporosis dose. Nevertheless, the overall risk for any infection or related mortality is similar to comparator groups. These findings merit consideration before therapy initiation.

IntroductionVaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited.MethodsA multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2–6 weeks after the second vaccine dose. Seropositivity was defined as IgG ≥15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose.ResultsFollowing vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, pConclusionmRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.

Administration of a BNT162b2 booster dose (Pfizer-BioNTech) to fully vaccinated individuals aged 60 years and older was significantly associated with lower risk of SARS-CoV-2 infection and severe illness. Data are lacking on the effectiveness of booster doses for younger individuals and health care workers.To estimate the association of a BNT162b2 booster dose with SARS-CoV-2 infections among health care workers who were previously vaccinated with a 2-dose series of BNT162b2.This was a prospective cohort study conducted at a tertiary medical center in Tel Aviv, Israel. The study cohort included 1928 immunocompetent health care workers who were previously vaccinated with a 2-dose series of BNT162b2, and had enrolled between August 8 and 19, 2021, with final follow-up reported through September 20, 2021. Screening for SARS-CoV-2 infection was performed every 14 days. Anti-spike protein receptor binding domain IgG titers were determined at baseline and 1 month after enrollment. Cox regression with time-dependent analysis was used to estimate hazard ratios of SARS-CoV-2 infection between booster-immunized status and 2-dose vaccinated (booster-nonimmunized) status.Vaccination with a booster dose of BNT162b2 vaccine.The primary outcome was SARS-CoV-2 infection, as confirmed by reverse transcriptase-polymerase chain reaction.Among 1928 participants, the median age was 44 years (IQR, 36-52 years) and 1381 were women (71.6%). Participants completed the 2-dose vaccination series a median of 210 days (IQR, 205-213 days) before study enrollment. A total of 1650 participants (85.6%) received the booster dose. During a median follow-up of 39 days (IQR, 35-41 days), SARS-CoV-2 infection occurred in 44 participants (incidence rate, 60.2 per 100 000 person-days); 31 (70.5%) were symptomatic. Five SARS-CoV-2 infections occurred in booster-immunized participants and 39 in booster-nonimmunized participants (incidence rate, 12.8 vs 116 per 100 000 person-days, respectively). In a time-dependent Cox regression analysis, the adjusted hazard ratio of SARS-CoV-2 infection for booster-immunized vs booster-nonimmunized participants was 0.07 (95% CI, 0.02-0.20).Among health care workers at a single center in Israel who were previously vaccinated with a 2-dose series of BNT162b2, administration of a booster dose compared with not receiving one was associated with a significantly lower rate of SARS-CoV-2 infection over a median of 39 days of follow-up. Ongoing surveillance is required to assess durability of the findings.

This study aimed to compare the real-life results of TECAM, a thiotepa-based conditioning regimen consisting of thiotepa (40 mg/m2 days −5 to −2), etoposide (200 mg/m2 days −6 to −3), cytarabine (200 mg/m2 days −4 to −1), cyclophosphamide (60 mg/kg day −3), and melphalan (60 mg/m2 days −2 to −1) with that of the conventional carmustine-based regimen BEAM. We reviewed 125 consecutive patients who underwent a first autologous transplantation (ASCT) for B-cell lymphomas at a large tertiary transplantation center between 1999 and 2014. TECAM (n=65) and BEAM (n=60) had comparable results (3yPFS 49 vs 62%, P=0.16; 3yOS 64 vs 71%, P=0.44; TRM 1.6 vs 5%, P=0.35) without a difference in toxicity or time to engraftment. Notably, comparable outcomes were observed even though patients treated with TECAM were older (55 vs 44) and had a trend towards more prior lines of therapy (>2 prior lines: 43 vs 27%, P=0.08). In this regard, 23% of TECAM patients were over the age of 65 yet could withstand therapy with similar results to younger patients. We conclude that, replacing carmustine by thiotepa and cyclophosphamide for ASCT conditioning, has comparable efficacy and safety profiles with a possible advantage in older patients.

(2003). Learning With and Learning From: Reciprocity in Service Learning in Teacher Education. Equity & Excellence in Education: Vol. 36, No. 1, pp. 15-27.

The management and utilization of collected data is crucial in evaluating programs and functional area effectiveness. Various assessment instruments may address similar functional areas of the college, yet we often fail to compile these data for comprehensive evaluation. The data collection matrix makes possible the integration of functional area data from numerous assessment sources and presentation of the information in a unified composite report. The matrix model will be discussed in relation to the various assessment instruments and the evaluation of functional areas and programs. This paper is directed toward institutional researchers who may wish to adapt the model to their own institution.

Introduction: Autologous Stem Cell Transplantation (ASCT) has become the cornerstone of managing relapsed lymphomas. However, its use in elderly patients or those with comorbidities is limited because of high regimen related toxicities (RRT). Several chemotherapy regimens have been suggested to minimize RRT while maintaining the antitumor effect. TECAM (Thiotepa 160 mg/m2 over 4 days , Etoposide and Cytarabine 800mg/m2 over 4 days, Cytoxan 60 mg/kg, and Melphalan 120 mg/m2 over 2 days) is a reduced toxicity modification for the commonly used BEAM protocol. Aim: This study aimed to compare the safety and efficacy or the TECAM regimen with that of its more intense BEAM counterpart. Methods: A retrospective cohort study of all patients who underwent ASCT for treatment of lymphoma with either BEAM or TECAM conditioning regimens at the Tel Aviv Medical Center between October 1999 and January 2014. We compared early (≤100 days) mortality, RRT rate, time to engraftment and length of hospitalization as well as overall and progression free survival. Results: A total of 146 patients (76 BEAM, 70 TECAM) were included in the analysis. Median follow up was 47 months. Patient treated with TECAM were older (54.5 vs. 45.5, p=0.001), and nearly 20% (n=13) of them had dose reductions (average 17±7%), as opposed to a single patient in the BEAM arm. Conversely, TECAM patients had a longer time interval from first diagnosis to transplant (22 vs. 13 months, p There was no statistically significant difference in PFS (26 months vs. not reached, TECAM vs. BEAM, p=0.16), nor in OS (not reached for both, p=0.55). In multivariable analysis the only factor associated with PFS was not entering transplantation in CR (HR 2.4, 95% CI 1.4-4.0, p=0.001). Similarly, factors associated with OS were older age (HR 1.023, 95% CI 1.004-1.043 per year, p=0.016) and non-CR at transplantation (HR 2.4, 95% CI 1.4-4.4, p=0.003). Discussion: We found comparable results for BEAM and its low toxicity counterpart TECAM. There were no differences in early mortality, RRT, time to engraftment, PFS, or OS. This was despite the fact that patients treated with TECAM were, on average, nine years older, and probably perceived to be frailer as indicated by a considerably higher rate of dose reductions. This study has several limitations that extend beyond its retrospective single institution nature. It encompasses a heterogeneous group of lymphomas, and there was possibly a selection bias allocating patients with a more severe disease to BAEM. Regardless, it suggests that TECAM could provide a lower toxicity alternative for ASCT conditioning in a selected group of patients. Table 1. Baseline characteristics BEAM (n=76) TECAM (n=70) p vlaue Age* 45.5 [29.5-54.0] 54.5 [41.3-65.0] 0.001 Sex (female) 31 (40.8%) 32 (45.7%) 0.67 Lymphoma type 0.09 Diffuse large B cell 32 (42.1%) 35 (50.7%) Hodgkin's 15 (19.7%) 15 (21.7%) T Cell 16 (21.1%) 4 (5.80%) Follicular 3 (3.95%) 6 (8.70%) Mantle cell 7 (9.21%) 8 (11.6%) Other 3 (3.95%) 1 (1.45%) Months from diagnosis* 13 [9-22] 22 [12-37] Figure 1. Overall and progression free survival Figure 1. Overall and progression free survival Disclosures Rozovski: Novartis: Other: Advisory board.

Several aspects of gender concept development were investigated in 60 children of mixed socioeconomic background ranging in age from 3 to 6 years. Tasks were designed to assess gender constancy, knowledge of sex stereotypes, differential memory and preference for sex-typed material, and gender categorization. Cognitive maturity was assessed with a conservation task and total recall on a memory task. Performance improved linearly with age on the gender concepts, individual children of both sexes learned the gender concepts in the same sequence, and cognitive maturity measures were positively related to performance on the gender concept tasks.

The results of two studies indicated that infant vocalizations can be conditioned by using only one or two elements of the traditionally employed composite social reinforcer, consisting of auditory, tactile, and visual stimuli. It was also found that the components, both singly and in pairs, are of relatively equal effectiveness in increasing response rate.