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Biologics, Volume 2, Issue 4 (December 2022) – 2 articles

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17 pages, 810 KiB  
Review
Virus-like Particles (VLPs) as Important Tools for Flavivirus Vaccine Development
by Leda R. Castilho, Nathalia R. Mattos, Wallace S. Abreu and Melissa L. E. Gutarra
Biologics 2022, 2(4), 226-242; https://doi.org/10.3390/biologics2040018 - 31 Oct 2022
Cited by 4 | Viewed by 4656
Abstract
Flaviviruses, such as dengue, zika, yellow fever, West Nile, and Japanese encephalitis virus, are RNA viruses belonging to the Flaviviridae family (genus Flavivirus). They represent an important global health concern, since most areas of the world are endemic for at least one of [...] Read more.
Flaviviruses, such as dengue, zika, yellow fever, West Nile, and Japanese encephalitis virus, are RNA viruses belonging to the Flaviviridae family (genus Flavivirus). They represent an important global health concern, since most areas of the world are endemic for at least one of these viruses. Although vaccines for five flaviviruses currently exist, there is a need for new vaccines to protect from established, emerging, and reemerging flaviviruses. Yellow fever vaccine shortages experienced in the last decade, combined with the risk of YFV spread to Asia and the restrictions of vaccine administration to certain population segments, show that even when a highly efficacious vaccine is available, new and improved vaccines might be needed. Virus-like particles (VLPs) are multiprotein structures that mimic the virus, but do not contain its genetic material. As such, VLPs have an excellent track record of strong immunogenicity and high safety, dating back to the introduction of the first recombinant hepatitis B vaccine in the 1980s. Flavivirus-like particles (FVLPs) have been extensively studied, especially for DENV, JEV, and ZIKV, and could give rise to next-generation recombinant subunit flavivirus vaccines based on VLPs incorporating molecular features intended to ensure high efficacy and minimize the risk of antibody-dependent enhancement (ADE) upon infection with other flaviviruses. Full article
(This article belongs to the Section Vaccines)
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Article
Real-World Effectiveness and Safety of SDZ-ADL (Adalimumab Biosimilar) in Patients with Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR)
by Lluís Puig, Kave Shams, Fabricio Furlan, Cristofer Salvati, Elisa Romero, Jamie Fan and Lars Iversen
Biologics 2022, 2(4), 213-225; https://doi.org/10.3390/biologics2040017 - 30 Sep 2022
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Abstract
SDZ-ADL is a biosimilar of reference adalimumab. Here, the safety and effectiveness data of SDZ-ADL from the British Association of Dermatologists Biologic and Immuno-modulators Register (BADBIR) are reported. In the safety set, data of SDZ-ADL were compared with conventional systemics data. In the [...] Read more.
SDZ-ADL is a biosimilar of reference adalimumab. Here, the safety and effectiveness data of SDZ-ADL from the British Association of Dermatologists Biologic and Immuno-modulators Register (BADBIR) are reported. In the safety set, data of SDZ-ADL were compared with conventional systemics data. In the effectiveness set, the effectiveness and quality-of-life of patients treated with SDZ-ADL as a first-time biologic, or who switched from a previous biologic to SDZ-ADL, were assessed using the Psoriasis Activity Severity Index (PASI) and Dermatology Life Quality Index (DLQI), respectively. A total of 565 (incidence rate (IR) per 1000 person-years 29.1, 95% CI 26.8–31.6) serious infections and 48 (IR 2.5, 95% CI 1.8–3.3) myocardial infarction events were reported in the conventional systemics cohort compared with four (IR 31.5, 95% CI 8.6–80.7) and one (IR 7.9, 95% CI 0.2–43.9) in the biologic cohort, respectively. One patient (0.7% (1/136)) reported injection-site pain in the biologic cohort. At 12 months, PASI ≤ 2 was achieved in 84.6% (11/13) and 76.9% (10/13) and DLQI 0/1 was achieved in 70% (7/10) and 75% (3/4) of patients in the biologic-naïve and biologic-switch cohorts, respectively. After one year of therapy, 82.7% (110/133) patients remained on SDZ-ADL. SDZ-ADL was well-tolerated and effective in patients with psoriasis. Full article
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