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. 2024 Oct 11;12(10):1157.
doi: 10.3390/vaccines12101157.

Did We Overreact? Insights on COVID-19 Disease and Vaccination in a Large Cohort of Immune-Mediated Inflammatory Disease Patients during Sequential Phases of the Pandemic (The BELCOMID Study)

Jeroen Geldof  1   2 , Marie Truyens  1   2 , João Sabino  3   4 , Marc Ferrante  3   4 , Jo Lambert  5 , Hilde Lapeere  5 , Tom Hillary  6 , An Van Laethem  6 , Kurt de Vlam  7 , Patrick Verschueren  7 , Triana Lobaton  1   2 , Elizaveta Padalko  8 , Séverine Vermeire  3   4
Affiliations

Did We Overreact? Insights on COVID-19 Disease and Vaccination in a Large Cohort of Immune-Mediated Inflammatory Disease Patients during Sequential Phases of the Pandemic (The BELCOMID Study)

Jeroen Geldof et al. Vaccines (Basel). .

Abstract

Introduction: As the COVID-19 pandemic becomes an endemic state, still many questions remain regarding the risks and impact of SARS-CoV-2 infection and vaccination in patients with immune-mediated inflammatory diseases (IMIDs) who were excluded from the phase 3 COVID-19 vaccination trials.

Methods: The BELCOMID study collected patient data and serological samples from a large, multicentric IMID patient cohort that was prospectively followed during sequential stages of the pandemic. Patients were stratified according to vaccination status into five groups across three sampling periods. Interactions between SARS-CoV-2 infection, COVID-19 vaccination status, IMID-treatment modalities and IMID course were explored.

Results: In total, 2165 patients with IBD, a dermatological or rheumatological IMID participated. SARS-CoV-2 infection rates increased over the course of the pandemic and were highest in IMID patients that had refused every vaccine. After baseline COVID-19 vaccination, serologic spike (S)-antibody responses were attenuated by particular types of immune-modulating treatment: anti-TNF, rituximab, JAKi, systemic steroids, combined biologic/immunomodulator treatment. Nonetheless, S-antibody concentration increased progressively in patients who received a booster vaccination, reaching 100% seroconversion rate in patients who had received two booster vaccines. Previous SARS-CoV-2 infection was found as a predictor of higher S-antibody response. Patients who had refused every vaccine showed the lowest rates of S-seroconversion (53.8%). Multiple logistic regression did not identify previous SARS-CoV-2 infection as a risk factor for IMID flare-up. Furthermore, no increased risk of IMID flare-up was found with booster vaccination.

Conclusions: Altogether, the BELCOMID study provides evidence for the efficacy and safety of COVID-19 vaccination and confirms the importance of repeated booster vaccination in IMID patients.

Keywords: COVID-19; IMID; booster; real world; vaccination.

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Conflict of interest statement

Jeroen Geldof reports service as an advisory board member or speaker for Arena, Janssen, Celltrion, Abbvie, Viatris, Galapagos/Alfasigma and Takeda. Marie Truyens reports no conflicts of interest related to this project. João Sabino received speaker’s fees from Pfizer, Abbvie, Ferring, Falk, Takeda, Janssen, and Fresenius. JS received consultancy fees from Janssen, Ferring, Fresenius, Abbvie, Galapagos, Celltrion, Pharmacosmos, and Pharmanovia. Research support: Galapagos and Viatris. JS is supported by a Senior Clinical researcher grant from the Research foundation—Flanders. Marc Ferrante reports receipt of research grants from AbbVie, Biogen, EG, Janssen, Pfizer, Takeda and Viatris; consultancy fees from AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, MRM Health, MSD, Pfizer, Takeda and ThermoFisher; and speakers’ fees from AbbVie, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen-Cilag, MSD, Pfizer, Takeda, Truvion Healthcare and Viatris. Jo Lambert has received recent grants/speaker fees of and performed consulting for AbbVie, Almirall, Bristol Myers Squibb, Celtrion, Janssen, Eli Lilly, Novartis, UCB Pharma—not personally, but paid to an institutional university account. Hilde Lapeere reports the following conflicts of interest: consultancy from AbbVie, Almirall, Leo Pharma, Eli Lilly, Celltrion, Novartis, Sanofi; speaker fees from Almirall, Leo Pharma, Eli Lilly, research funding from Pfizer. Tom Hillary reports the following conflicts of interest: consultancy from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen, Leo Pharma, Eli Lilly, Novartis, Sandoz, UCB Pharma, EG, Celltrion; speaker fees from AbbVie, Almirall, Amgen, Biogen, Celgene, Janssen, Leo Pharma, Eli Lilly, Novartis, Sanofi, UCB Pharma, Celltrion; research funding from AbbVie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, UCB Pharma, EG, Celltrion. An Van Laethem reports having received personal fees for participation on an advisory board, consultancy and/or as a speaker for Abbvie, Sanofi, Janssen, UCB, Novartis, Galderma. Kurt de Vlam reports being a consultant or speaker for Abbvie, Eli Lilly, Novartis, Pfizer, MSD, Acelyrin, UCB Pharma, Leo Pharma, Amgen and has received financial research support from UCB Pharma and Celgene. Patrick Verschueren reports having received research grants from Pfizer and Galapagos/AlfaSigma; consultancy fees from Pfizer, Galapagos, AlfaSigma, Lilly, Boehringer Ingelheim, Sidekick Health and Cytryl; speakers’ fees from Abbvie, Galapagos, Lilly, Roularta and Medicongress; and travel support from Fresenius Kabi and Abbvie. Triana Lobaton reports having received: (1) research grants from Abbvie, Mylan, MSD, Mundipharma, Biogen, Janssen, Pfizer, EG, Celltrion, Viatris Takeda; (2) speaker fees from Ferring, MSD, Abbvie, Janssen, Amgen, Fresenius Kabi, Alfasigma, Celltrion, Viatris and Takeda; (3) consultancy fees from Janssen, Galapagos, Alfasigma, Amgen, Bristol Myers Squibb Fresenius Kabi and Takeda. Elizaveta Padalko has received a consultant speaker’s fees/travel grants on institutional account from Hologic, bioMerieux, DiaSorin, Novosanis. Séverine Vermeire receives financial support for research from AbbVie, J&J, Pfizer, Takeda and Galapagos; receives speakers’ and consultancy fees from AbbVie, Abivax, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, Mestag Therapeutics, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Surrozen, Takeda, Theravance, Tillots Pharma AG, VectivBio, Ventyx, Zealand Pharma. Séverine Vermeire holds a BOF-FKM from the KU Leuven.

Figures

Figure 1
Figure 1
BELCOMID timeline. Interim results from inclusion periods 1 and 2 were published previously [7]. The current manuscript considers all 3 inclusion periods and 5 vaccination groups.
Figure 2
Figure 2
Estimated mean S-serology evolution across vaccination groups.
See this image and copyright information in PMC

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