SARS-CoV-2 infection and COVID19 vaccination across eight immune-mediated inflammatory disorders: A prospective, real-life Belgian cohort study - the BELCOMID study.

Background: The risks and impact of COVID19 disease and vaccination in patients with Immune Mediated Inflammatory Diseases (IMID) remain incompletely understood. IMID patients and particularly patients receiving immunosuppressive treatment were excluded from the original, registrational phase-3 COVID19 vaccination efficacy and safety trials. Real-world observational data can help to fill this gap in knowledge. The BELCOMID study aims to explore the interaction between IMIDs, immune-modulating treatment modalities and SARS-CoV-2 infection and vaccination in a real-life patient cohort.
Methods: A multidisciplinary, prospective, observational cohort study was set up. Consecutive patients with IMIDs of the gut, joints and skin followed at two high-volume referral centers were invited. Both patients under conventional treatment or targeted immune modulating therapies were included. Patient data and serological samples were collected at 3 predefined periods (before COVID19 vaccination, before booster vaccination, after booster vaccination). Primary endpoints were positive PCR-test and SARS-CoV-2 serology reflecting previous SARS-CoV-2 infection or vaccination. Associations with IMID treatment modality and IMID disease activity were assessed. Results of the first two inclusion periods (before booster vaccination) are reported.
Results: At the first inclusion period data was assessed of 2165 IMID-patients before COVID19 vaccination. At the second inclusion period, data of 2065 patients was collected of whom 1547 had received complete baseline COVID19 vaccination and 222 were partially vaccinated. SARS-CoV-2 infection rate remained low in both groups. No significant increase in IMID flare-up rate was noted in patients with prior SARS-CoV-2 infection. Multiple logistic regression analyses did not show a significant influence of IMID-treatment modality or IMID activity on SARS-CoV-2 infection risk (based on PCR positivity or N-serology). Patients treated with conventional immunomodulators, systemic steroids, and patients on advanced therapies such as biologics or small molecules, had reduced S-antibody seroconversion. S-antibody response was also lower in patients without prior SARS-CoV-2 infection and in active smokers. A subset of patients (4.1%) had no S- nor N-antibody seroconversion following complete baseline vaccination.
Conclusion: The BELCOMID study results confirm the benign course of COVID19 infection and vaccination in a large real-life IMID-population. However, our results underscore the need for repeated vaccination and smoking cessation in patients with IMIDs treated with immune-modulating therapies or systemic steroids during the pandemic.
Competing Interests: The BELCOMID study group received research grants from following pharmaceutical companies: Almirall, Roche, Janssen, Pfizer, Eli Lilly, Amgen, Biogen, Mylan, LEO Pharma. These companies had no role in study design, conduct nor reporting of results. JG has served as advisory board member or speaker for Arena, Janssen and Galapagos. JS 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. MF reports being a consultant or speaker for AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Dr Falk, Ferring, Janssen-Cilag, Lamepro, Eli Lilly, Medtronic, Merck Sharp & Dohme MSD, Mylan, Pfizer, Regeneron, Samsung Bioepis, Sandoz, Takeda, Thermo Fisher Scientific, and Truvion Healthcare; and received research grants from AbbVie, Amgen, Biogen, Janssen, Pfizer, Takeda, and Viatris. JL has received recent grants/speaker fees of and did consulting for AbbVie, Almirall, Bristol Myers Squibb, Celtrion, Janssen, Eli Lilly, Novartis, UCB Pharma – not personal but paid to an institutional university account. HL reports receiving consultancy or speaker fees from AbbVie, Almirall, Amgen, Leo Pharma, Pfizer, – not personal but paid to an institutional university hospital account. TH has received grants and consulting and/or speaking fees from: AbbVie, Almirall, Amgen, Biogen, Bristol Myers Squibb, Celgene, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer Inc, Sandoz, Sanofi, UCB Pharma. AL reports being a consultant or speaker for: AbbVie, Bayer, Falk Pharma, Janssen, Eli Lilly, Novartis, Pfizer Inc, Sanofi, UCB Pharma. KV 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. PV reports being a consultant or speaker for Abbvie, Eli Lilly, Galapagos, Gilead, MSD, Nordic Pharma, Roularta, Sidekick Health and has received financial research support from Pfizer. EP has received a consultant of speaker’s fees/travel grants on institutional account from Hologic, bioMerieux, DiaSorin, Novosanis. TL has received financial support for research from Abbvie, Mylan, MSD, Mundipharma, Biogen, Janssen, Pfizer and Takeda, Speaker fees fromFerring, MSD, Abbvie, Janssen, Amgen, Fresenius Kabi, Galapagos and Takeda and Consultancy fee from Janssen, Galapagos, Amgen, Bristol Myers Squibb, Fresenius Kabi and Takeda. SV has received grants from AbbVie, J&J, Pfizer, Takeda and Galapagos; and consulting and/or speaking fees from: AbbVie, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillots Pharma AG, Zealand Pharma. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2023 Geldof, Truyens, Sabino, Ferrante, Lambert, Lapeere, Hillary, Van Laethem, de Vlam, Verschueren, Padalko, Lobaton and Vermeire.)