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    Attaching a stigma to the LGBTQI plus community should be avoided during the monkeypox epidemic
    (Wiley, 2023) Bragazzi, Nicola Luigi; Khamisy-Farah, Rola; Tsigalou, Christina; Mahroum, Naim; Converti, Manlio
    Dear Editor,An outbreak of monkeypox, a rare zoonotic disease caused by anorthopoxvirus, is currently ongoing and has spread so far to morethan 20 countries, mostly affecting Europe, the Americas, Australia,and Israel, with more than 400 confirmed cases (https://bnonews.com/monkeypox/), becoming the largest monkeypox epidemicoutside of western and central Africa, where it is endemic in elevencountries.1In the UK, where the first monkeypox case was reportedon May 7, 2022, in a traveler returning from Nigeria, the National“Health Security Agency”(UKHSA) has reported that“a notableproportion of early cases detected have been in gay and bisexual menand so UKHSA is urging this community in particular to be alert”
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    COVID-19 vaccination and the rate of immune and autoimmune adverse events following immunization: Insights from a narrative literature review
    (Frontiers Media S.A., 2022) Mahroum, Naim; Lavine, Noy; Ohayon, Aviran; Seida, Ravend; Alwani, Abdulkarim; Alrais, Mahmoud; Zoubi, Magdi; Bragazzi, Nicola Luigi
    Despite their proven efficacy and huge contribution to the health of humankind, vaccines continue to be a source of concern for some individuals around the world. Vaccinations against COVID-19 increased the number of distressed people and intensified their distrust, particularly as the pandemic was still emerging and the populations were encouraged to be vaccinated under various slogans like “back to normal life” and “stop coronavirus”, goals which are still to be achieved. As fear of vaccination-related adverse events following immunization (AEFIs) is the main reason for vaccine hesitancy, we reviewed immune and autoimmune AEFIs in particular, though very rare, as the most worrisome aspect of the vaccines. Among others, autoimmune AEFIs of the most commonly administered COVID-19 vaccines include neurological ones such as Guillain-Barre syndrome, transverse myelitis, and Bell’s palsy, as well as myocarditis. In addition, the newly introduced notion related to COVID-19 vaccines, “vaccine-induced immune thrombotic thrombocytopenia/vaccine-induced prothrombotic immune thrombotic thrombocytopenia” (VITT/VIPITT)”, is of importance as well. Overviewing recent medical literature while focusing on the major immune and autoimmune AEFIs, demonstrating their rate of occurrence, presenting the cases reported, and their link to the specific type of COVID-19 vaccines represented the main aim of our work. In this narrative review, we illustrate the different vaccine types in current use, their associated immune and autoimmune AEFIs, with a focus on the 3 main COVID-19 vaccines (BNT162b2, mRNA-1273, and ChAdOx1). While the rate of AEFIs is extremely low, addressing the issue in this manner, in our opinion, is the best strategy for coping with vaccine hesitancy.
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    HIV pre-exposure prophylaxis and its impact on the gut microbiome in men having sex with men
    (Frontiers Media S.A., 2022) Bragazzi, Nicola Luigi; Khamisy-Farah, Rola; Tsigalou, Christina; Mahroum, Naim
    HIV/AIDS still imposes a high epidemiological and societal burden. Together with antiretroviral therapy, pre-exposure prophylaxis (PrEP) represents a fundamental tool in the fight against HIV/AIDS. PrEP is considered effective and safe, even though it may affect organs like the kidney, bone, and liver, as shown by randomized clinical trials (RCTs). These side effects may be mediated by alterations of the gut microbiome. Whilst the impact of the human rectal and vaginal microbiome on HIV prevention has been highly investigated among women, less is known about its effect among men having sex with men (MSM), a vulnerable population at high risk for HIV and disproportionately affected by HIV/AIDS. In the present paper, we will overview the effects of PrEP on the gut microbiota in MSM. Mining PubMed/MEDLINE, we identified three studies that have found significant changes affecting the gut microbiota. However, these shifts in the gut microbiome composition are variable, probably due to methodological differences, even though all studies reviewed in the present overview consistently report aberrations at the level of the gut microbiota. More data are needed, especially concerning the long-term side effects of PrEP: despite the studies included being a high-quality RCT, and two well-designed cross-sectional studies, evidence related to the impact of HIV PrEP on the gut microbiome in MSM is scarce and based on small populations. A better understanding of the interactions between the gut microbiota, sexual orientation/identity, and HIV prevention is expected to improve PrEP adherence and devise strategies to counteract PrEP-related side effects.
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    Infectious side effects of baricitinib: A big data analysis based on VigiBase
    (Elsevier B.V., 2023) Mahroum, Naim; Özkan, Mehmet Fatih; Abalı, Tunahan; Yılmaz, Mesut; Bragazzi, Nicola Luigi
    Dear Editor, Baricitinib (known as “Olumiant”), is an inhibitor of Janus- associated kinase 1 and 2 (JAK1 and JAK2) initially introduced for the treatment of rheumatoid arthritis (RA), and later for systemic lupus erythematosus (SLE), and atopic dermatitis [1]. The first approval of baricitinib was from the European Medicines Agency (EMA) as a mon- otherapy or combination therapy with methotrexate for patients with RA unresponsive to disease-modifying anti-rheumatic drugs (DMARDs)
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    Systematic review and meta-analysis of tocilizumab therapy versus standard of care in over 15,000 COVID-19 pneumonia patients during the first eight months of the pandemic
    (MDPI, 2021) Mahroum, Naim; Watad, Abdulla; Bridgewood, Charlie; Mansour, Muhammad; Nasr, Ahmad; Hussein, Amr; Khamisy-Farah, Rola; Farah, Raymond; Gendelman, Omer; Lidar, Merav; Shoenfeld, Yehuda; Amital, Howard; Kong, Jude Dzevela; Wu, Jianhong; Bragazzi, Nicola Luigi; McGonagle, Dennis
    Background. Tocilizumab is an anti-IL-6 therapy widely adopted in the management of the so-called "cytokine storm" related to SARS-CoV-2 virus infection, but its effectiveness, use in relation to concomitant corticosteroid therapy and safety were unproven despite widespread use in numerous studies, mostly open label at the start of the pandemic. Methods: We performed a systematic review and meta-analysis of case-control studies utilising tocilizumab in COVID-19 on different databases (PubMed/MEDLINE/Scopus) and preprint servers (medRxiv and SSRN) from inception until 20 July 2020 (PROSPERO CRD42020195690). Subgroup analyses and meta-regressions were performed. The impact of tocilizumab and concomitant corticosteroid therapy or tocilizumab alone versus standard of care (SOC) on the death rate, need for mechanical ventilation, ICU admission and bacterial infections were assessed. Results. Thirty-nine studies with 15,531 patients (3657 cases versus 11,874 controls) were identified. Unadjusted estimates (n = 28) failed to demonstrate a protective effect of tocilizumab on survival (OR 0.74 ([95%CI 0.55-1.01], p = 0.057), mechanical ventilation prevention (OR 2.21 [95%CI 0.53-9.23], p = 0.277) or prevention of ICU admission (OR 3.79 [95%CI 0.38-37.34], p = 0.254). Considering studies with adjusted, estimated, tocilizumab use was associated with mortality rate reduction (HR 0.50 ([95%CI 0.38-0.64], p < 0.001) and prevention of ICU admission (OR 0.16 ([95%CI 0.06-0.43], p < 0.001). Tocilizumab with concomitant steroid use versus SOC was protective with an OR of 0.49 ([95%CI 0.36-0.65], p < 0.05) as was tocilizumab alone versus SOC with an OR of 0.59 ([95%CI 0.34-1.00], p < 0.001). Risk of infection increased (2.36 [95%CI 1.001-5.54], p = 0.050; based on unadjusted estimates). Conclusion: Despite the heterogeneity of included studies and large number of preprint articles, our findings from the first eight of the pandemic in over 15,000 COVID-19 cases suggested an incremental efficacy of tocilizumab in severe COVID-19 that were confirmed by subsequent meta-analyses of large randomized trials of tocilizumab. This suggests that analysis of case-control studies and pre-print server data in the early stages of a pandemic appeared robust for supporting incremental benefits and lack of major therapeutic toxicity of tocilizumab for severe COVID-19.
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    The COVID-19 pandemic – How many times were we warned before?
    (Elsevier B.V., 2022) Mahroum, Naim; Seida, İsa; Esirgün, Şevval Nil; Bragazzi, Nicola Luigi
    Infectious diseases are known to act in both predictable and unpredictable ways, which leads to the notions of emerging and reemerging infectious diseases. Emerging diseases with their disastrous consequences might be surprising and unpredictable, but they could be foreseen. For instance, some emerging diseases and recently the coronavirus disease 2019 (COVID-19) were the reason for papers published by the World Health Organization (WHO) and other researchers addressing the likely pathogens causing future outbreaks, according to the reports of the WHO in 2016 and 2018. Although it might seem like a wisdom in retrospect, several studies had already indicated possible future outbreaks caused by coronaviruses. Announcements, which may be viewed as “warnings,” appeared since the emergence of the first coronavirus-related outbreak caused by severe acute respiratory syndrome coronavirus (SARS-CoV) in the winter of 2002–2003 and a later outbreak caused by the Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012–2013. Therefore, we were curious to review the medical literature prior to the COVID-19 pandemic with an aim to enumerate and evaluate studies addressing and warning against future outbreaks, and surprisingly pandemics, of members of coronaviruses. Interestingly, we found numerous studies that correctly predicted the current pandemic of COVID-19. While this part is highly interesting, how authorities reacted and prepared for warnings, if any, and how will they get prepared for the next warnings are our main messages. Taking these points into serious consideration will certainly aid in analyzing reports regarding possible future outbreaks as well as in developing various strategies for prevention and coping with such epidemics.