Implementation of an Accelerated Infusion Protocol (90-Minute Infusion) of Rituximab and Its Safety in Patients With Autoimmune Rheumatic Diseases at a Tertiary Veterans Affairs Center.

Background Rituximab, a chimeric monoclonal antibody targeting the CD20 protein on the surface of B cells, is used to treat several rheumatologic and oncologic diseases. The standard infusion duration of rituximab is four hours. Objective Evaluating the safety of administering the accelerated 90-minute protocol at our Veterans Affairs center to patients with rheumatologic diseases and monitoring for any infusion-related reactions. This study is unique as it examines infusion rates faster than those most described (120 minutes). Methods Patients treated with rituximab for autoimmune diseases between June 2020 and June 2022 at our center were included in the study. Our patients were over 18 years of age, met the inclusion criteria, and had received previous rituximab infusions without prior infusion-related reactions. They received the accelerated protocol of 90 minutes over their next cycles and were monitored for any reactions during their infusions. Results A total of 34 patients receiving 76 infusions were included in the analysis. Most of the patients were males (n = 27). The most prevalent indication for rituximab infusion was rheumatoid arthritis (n = 20). Out of 76 infusions, only two infusion-related reactions were recorded (2.6% incidence). The first patient had itching and a sore throat, indicating a grade 1A reaction. The second patient developed chest pain and dyspnea, which resolved with diphenhydramine and albuterol. For both, the infusion was completed after appropriate management. Conclusion The incidence of infusion-related reactions during the accelerated 90-minute rituximab infusion was remarkably low and well-tolerated by our rituximab-experienced patients. Only two infusions were complicated by a reaction, an incidence comparable to or even lower than other reported 120-minute infusion protocols. This protocol is time- and cost-efficient, allowing for more infusions per chair per day at our center.

Disease characteristics, pathogenesis, and treatment controversies of axial psoriatic arthritis.

Axial psoriatic arthritis (axPsA) has considerable overlap with axial spondyloarthritis (axSpA) but has some unique features that sometimes preclude classification into axSpA. It has some clinical and radiographic differences compared to axSpA. Imaging typically shows asymmetric syndesmophytes, mainly in the cervical spine, with less frequent sacroiliitis. It more commonly presents later in life and is associated with less severe inflammatory back pain than axSpA. The interleukin (IL) IL-23/IL-17 axis is central to the pathogenesis of both diseases. However, the response to therapies targeting these cytokines has been different. IL-23 inhibitors are ineffective in axSpA but may be effective in psoriatic arthritis (PsA). Recent post hoc analyses of clinical trial data with IL-23 inhibitors in PsA have raised the possibility of their efficacy in axPsA and need evaluation in future clinical trials. Moreover, there is a need for classification criteria for axPsA and better tools to assess therapeutic response.

A Case Series on the COVID-19 Vaccines and Possible Immune-Related Adverse Events: A New Challenge for the Rheumatologists.

The COVID-19 pandemic has been a prime health issue since December 2019. Consequently, there has been an urgent need to prevent severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) infection and its associated morbidity and mortality. The currently available vaccines are designed to prevent infection. Their efficacy and safety have been demonstrated in clinical trials. Yet, given the short duration of the trials and the urgency to start vaccination, adverse events have been reported worldwide in real-life data format. Immune-mediated disease flares or new-onset inflammatory diseases following vaccine administration have recently been reported worldwide. Here, we present three cases of inflammatory arthritis (IA) caused by the BNT162b2 COVID vaccination, including two new-onset cases and one case of a flare of existing disease. The first case is new-onset IA, the second case is new-onset rheumatoid arthritis, and the third case is a flare of existing rheumatoid arthritis. Given the timeline of when our patients developed either a flare of their existing rheumatoid arthritis or new-onset IA or polymyalgia rheumatica (PMR) (a few days after receiving the COVID-19 vaccine), in addition to the currently available evidence of documented similar cases post administration of mRNA vaccines, as well as the link between their mechanism of action and the pathogenesis of those diseases, we can speculate a causal relationship between the vaccine and the triggering of these disease entities. In the future, it is important to consider that autoimmune diseases might be triggered or flared by the administration of vaccines, which appears to be associated with the COVID vaccine as well. Further evaluation of its incidence will provide additional clarity, though the rarity of this occurrence in the setting of more than half of the US population becoming vaccinated indicates that the benefit of the vaccine in terms of protection from COVID morbidity and mortality far outweighs this risk.

Lebanese Hospital-Based Rheumatoid Arthritis Registry: Characteristics of Patients and Comparison with Other Populations.

Objectives: The aim of the Lebanese hospital-based Rheumatoid Arthritis (RA) registry, initiated in 2011, is to evaluate the safety and efficacy of biologic agents among patients seeking care at the American University of Beirut Medical Center (AUBMC). We aimed to characterize the demographic and clinical profile of RA patients included in the Lebanese registry. We compared our results with those issued from Middle Eastern and non-Middle Eastern registries. Methods: 195 Patients enrolled in the RA registry from 2011 to 2018 were considered in this study. Patients enrolled in the registry were eligible to be treated with biologics, but 56 patients remained biologics naïve. Patients were reassessed every six months. Results: The highest proportion of patients were female (81%). The mean age was 55.53±15 years, and the disease duration was 11.38±7.7 years. RA was diagnosed at a mean age of 44.13±16 years. Almost one-third of RA patients were smokers (29.2%) and 15% consumed alcohol. Comorbidities included cardiac diseases (30.8%), hypertension (24.6%), hyperlipidemia (11.8%), diabetes mellitus (9.2%), and Hypothyroidism (6.2%). Three cases of cancer and seven cases of tuberculosis were reported. The mean of the Disease Activity Score (DAS28) was 3.75 ± 2.28 with no difference according to gender; the mean of the Health Assessment Questionnaire (HAQ) score showed a significant difference between females and males (1.02 ± 0.84 and 0.61 ± 0.7 respectively). Methotrexate was the most commonly used medication. There was non-significant difference in taking biologics according to gender. Conclusion: Our findings are similar to other studies in terms of gender distribution. The higher mean age at diagnosis compared to other populations could indicate a delay in seeking appropriate care. The Lebanese RA registry provides valuable data on pharmacological interventions used and an opportunity to follow up to examine the effectiveness of different therapeutics and to monitor their side effects.

Outcomes of Patients with Malignancy Admitted to the Intensive Care Units: A Prospective Study.

INTRODUCTION: Decisions regarding whether advanced cancer patients should be admitted to the ICU are based on a complex suite of considerations, including short- and long-term prognosis, quality of life, and therapeutic options to treat cancer. We aimed to describe demographic, clinical, and survival data and to identify factors associated with mortality in critically ill advanced cancer patients with nonelective admissions to general ICUs. MATERIALS AND METHODS: Critically ill adult (≥18 years old) cancer patients nonelectively admitted to the intensive care units at the American University of Beirut Medical Center between August 1st 2015 and March 1st 2019 were included. Demographic, clinical, and laboratory data were prospectively collected from the first day of ICU admission up to 30 days after discharge. This study was strictly observational, and clinical decisions were left to the discretion of the ICU team and attending physician. RESULTS: 272 patients were enrolled in the study between August 1st 2015 and March 1st 2019, with an ICU mortality rate of 43.4%, with the number rising to 59% within 30 days of ICU discharge. The mean length of stay in our ICU was 14 days (IQR: 1-120) with a median overall survival of 22 days since the date of ICU admission. The major reasons for unplanned ICU admission were sepsis/septic shock (54%) and respiratory failure (33.1%). Cox regression analysis revealed 7 major predictors of poor prognosis. Direct admission from the ED was associated with a higher risk of mortality (48.9%) than being transferred from the floor (32.6%) (p=0.014). CONCLUSION: Our study has shown that being directly admitted to the ICU from the ED rather than being transferred from regular wards, developing AKI, sepsis, MOF, and ARDS, or having an uncontrolled malignancy are all predictive factors for short-term mortality in critically ill cancer patients nonelectively admitted to the ICU. Vasopressor use and mechanical ventilation were also predictors of mortality.

The Use of Infliximab (Remicade®) for the Treatment of Rheumatic Diseases at a Tertiary Center in Lebanon: A 17-Year Retrospective Chart Review.

OBJECTIVES: Infliximab (Remicade®) was the first tumour necrosis factor-α (TNF) inhibitor to receive its initial marketing approval from the US Food and Drug Administration (FDA) for the treatment of Crohn's disease. Following that, infliximab became approved for several immune-mediated inflammatory diseases. No evidence exists in the Middle East and North Africa region on the experience with infliximab use over an extended period in terms of efficacy and safety. METHODS: The Rheumatology division at the American University of Beirut Medical Centre (AUBMC), one of the largest tertiary centres in the Middle East and North Africa region, has been using infliximab infusions for the treatment of certain rheumatic diseases for around two decades. By reviewing retrospectively medical charts at AUBMC, we investigate indications, safety and efficacy, rate of withdrawals, rate of switching to another biologic, and financial coverage of the drug to present data for practitioners and patients in the region considering infliximab for treatment of immune-mediated inflammatory diseases. RESULTS: A total of 198 patients were identified in the past 17 years to have taken infliximab. The largest proportion of treated patients had RA. Fourteen percent of the total cohort experienced serious adverse events, with 96.4% of those events being mild hypersensitivity reactions. Five patients withdrew the medication because of infectious complications, 4 of which were cases of tuberculosis reactivation. Despite that, around half of the patients were switched to another biologic agent such anti-TNF-α, anti-CD20, and anti-IL-6 due to partial response, and less than half were receiving add-on disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, 70% of patients who used infliximab only or were switched achieved complete remission at their last hospital information. Around 98% of infliximab users were financially covered. CONCLUSION: According to our experience, infliximab has made remission and prevention of long-term disability realistic goals of therapy in the Middle East region.