Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Intravenous immune globulin (IVIG) therapy is used in patients with hypogammaglobulinemia to lower the risk of infections. IVIG and subcutaneous IVIG (SCIG) therapy have been to shown to be safe and effective when administered as clinic-based infusions. Concern from both patients and providers for increased transmission of the coronavirus disease 2019 (COVID-19) virus to immunosuppressed patients with scheduled medical visits and procedures made it necessary for us to reassess our process of how we manage patient care in general and chronic clinic infusions in particular. Here we describe our experience of transitioning patients from clinic-based to home based IVIG and/or SCIG infusions to decrease the risk of COVID-19 exposure. Methods Criteria were developed to identify high-risk immunosuppressed patients who would be appropriate candidates for potential conversion to home based IVIG infusions. Data were collected via chart review, and cost analysis was performed using Medicare Part B reimbursement data. A patient outcome questionnaire was developed for administration through follow-up phone calls. Results From March to May 2020, 45 patients met criteria for home-based infusion, with 27 patients (60%) agreeing to home-based infusion. Posttransition patient outcomes assessment, conducted in 26 patients (96%), demonstrated good patient understanding of the home-based infusion process. No infusion-related complications were reported, and 24 patients (92%) had no concerns about receiving future IVIG and/or SCIG doses at home. No patient tested positive for COVID-19 during the study period. Clinic infusion visits decreased by 26.6 visits per month, resulting in a total of 106 hours of additional available infusion chair time per month and associated cost savings of $12,877. Conclusion Transition of clinic based to home based IVIG/SCIG infusion can be successfully done to decrease potential exposure during a pandemic in a high-risk immunosuppressed population, with no impact on patient satisfaction, adherence, or efficacy. The home-based infusion initiative was associated with a reduction in costs to patients and an increase in available chair time in the infusion clinic.

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Background Bezlotoxumab has been shown to prevent recurrent episodes of C. difficile infection (CDI) in high risk patients. Current studies define therapeutic efficacy within the first 12 weeks when the risk of recurrence is greatest. However, the risk of recurrent CDI can occur beyond the 12-week window in the immunosuppressed population. Given that bezlotoxumab has detectable serum levels for up to 24 weeks after infusion, the primary endpoint is to determine overall efficacy in immunosuppressed patients with recurrent CDI at 4 weeks, 12 weeks, and 24 weeks after initial infusion. Secondary endpoints consist of risk factors for recurrent CDI, treatment of CDI, and antibiotics usage before and after bezlotoxumab. Methods This analysis included immunosuppressed patients at high risk for CDI recurrence who received bezlotoxumab from February 2017 to December 2019. Patients were excluded if they were not immunosuppressed, had no follow-up appointments, and/or without a C. difficile positive test. High risk antibiotics included fluoroquinolones, beta lactamase inhibitors, third generation cephalosporins, or carbapenems. Results Twenty-seven bezlotoxumab doses were given to 26 patients. Baseline characteristics for CDIs prior to bezlotoxumab is reported in Table 1. The overall CDI recurrence rate at all intervals after bezolotoxumab was 4 (15%), one recurrent CDIs occurred at < 4 weeks, two recurrent CDIs occurred at 5-12 weeks, and one recurrent CDI at 13-24 weeks. High risk antibiotics were given in 2/4 (50%) of CDIs recurrences and 22/75 (29%) in the non-recurrence group. Of the four CDI recurrences, all were mild to moderate in disease severity given no evidence of colitis was seen on CT scan and a median Zar score of 1 (range 0-1) due to age > 60 years. Table 1: Baseline Characteristics Conclusion In immunosuppressed patients with CDI, bezlotoxumab is effective at reducing CDI episodes up to 24 weeks. Additionally, this highly antibiotic exposed population continued to receive benefit up to 24 weeks after bezlotoxumab. Disclosures All Authors: No reported disclosures

Background: T-cell lymphomas constitute heterogeneous subtypes of non-Hodgkin lymphoma (NHL). With the exception of brentuximab (BV) with cyclophosphamide, adriamycin, prednisone (CHP) in anaplastic large cell lymphoma (ALCL) establishing a standard of care in this subtype, the choice of first-line therapy in other subtypes are based on CHOP like regimens with or without etoposide. Few studies have evaluated the efficacy of etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH) in patients with aggressive T-cell lymphomas. We report our single center experience in patients receiving EPOCH in frontline or relapsed/refractory (R/R) setting for aggressive T-cell lymphomas including transformed cutaneous T-cell lymphomas (CTCL). Methods:Adult patients with aggressive T-cell lymphomas who received EPOCH from May 2015 to October 2020 at Yale-New Haven Hospital were included in this analysis. Adverse effects were graded per the CTCAE criteria. Statistical analyses were performed using STATA 14.2. The primary objective was to determine the efficacy of EPOCH in terms of response rates and survival outcome. The secondary objective was to determine toxicity rates. Results: Thirty-eight patients with aggressive T-cell lymphomas were included in the study. This included angioimmunoblastic T-cell lymphoma (AITL) (n=7), adult T-cell leukemia/lymphoma (ATLL) (n=9), ALCL (n=2), peripheral T-cell lymphoma - not otherwise specified (PTCL-NOS) (n=7), T follicular helper (Tfh) subtype (n=1), subcutaneous panniculitis-like T-cell lymphoma (SPTCL) (n=1) and CTCL (n=11). Eighteen patients received EPOCH in the first line and 21 patients in R/R setting. The overall response rate (ORR) for the entire cohort was 77% and complete response (CR) rate was 51%. The CR rate in the frontline was 60% and in R/R setting was 45%. At a median follow up of 22.1 months (95% CI: 17.3 to 28.4), the median progression free survival (PFS) was 7.8 months (95% CI 4.3 to 9.8), and median overall survival (OS) was 19.7 months (12.1 to NR). Fifteen patients went onto allogeneic stem cell transplant after remission with EPOCH. The most common grade 3 adverse effects were anemia (63%), thrombocytopenia (34%), and neutropenia (32%). The most common grade 4 adverse effects were neutropenia (71%) and thrombocytopenia (39%). Discussion: This study reports the efficacy and safety results of EPOCH in T-cell lymphoma both in the first line in R/R setting.We found that EPOCH has excellent response rates and good tolerability in T-cell lymphomas. With CR rates of >50%, EPOCH is a promising backbone for combination trials in aggressive T-cell lymphomas targeting deep responses prior to consolidation with transplant. Our study is unique in including CTCL patients who required treatment with combination chemotherapy due to an aggressive clinical course and/or large cell transformation. Disclosures Foss: Kura: Honoraria; Kyowa: Honoraria; Mallinckrodt: Honoraria; Seattle Genetics: Honoraria, Speakers Bureau; Acrotech: Honoraria, Speakers Bureau; Daiichi Sankyo: Honoraria.

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