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Patients with immune-mediated inflammatory diseases (IMIDs) may have impaired initial humoral responses after SARS-CoV-2 vaccination depending on the type of immunosuppression (ISP) used.1 It is largely unknown how antibody titres develop over time and whether it is needed to adjust timing of booster campaigns for patients with IMID.
This is a study on long-term persistence of seroconversion after vaccination in patients with IMID on ISP, patients with IMID not on ISP and healthy controls. This study is part of an ongoing national prospective multicentre cohort study in the Netherlands (Target-to-B! study; trial ID NL8900). Participants were included from 2 February 2021 and 1 October 2021. Participants with seroconversion (ie, >4 AU/mL) after primary immunisation with either BNT162b2 or CX-024414 in whom serum samples were collected 28 days after primary immunisation and before the first additional vaccination were included. Patients with IMID on ‘strongly antibody-impairing immunosuppressants’ (ie, anti-CD20 therapies, sphingosine 1-phosphate receptor (S1PR) modulators and mycophenolate mofetil (MMF)) were offered a first additional vaccination 3 months after primary immunisation; others after 5–6 months. Participants with a SARS-CoV-2 breakthrough infection were excluded; inclusion and exclusion criteria for the overall study are described elsewhere.1 Clinical and serological data collection is described in the supplement. We measured anti-RBD IgG responses using ELISA.2 Serum samples used for this analyses were collected prior to the first additional vaccination. For analysis, patients with IMID with ‘strongly antibody-impairing immunosuppressants’ were separated from other ISPs (analysed as group and apart for the most frequently used other ISPs, ie, anti-TNF, methotrexate and purine antagonists).
A total of 877 patients with IMID with ISP (99 with ‘strongly antibody-impairing immunosuppressants’ and 778 other ISP) were compared with 356 controls (243 patients with IMID without ISP and 113 healthy controls; see online supplemental figure S1). Online supplemental table S1 shows …
Handling editor Josef S Smolen
LW and EWS contributed equally.
Contributors All authors met the criteria for authorship set by the International Committee of Medical Journal Editors. TR, MS, SK, JK, AEB and OC did the serological assays; all other authors contributed in data acquisition. LW, EWS, TWK and FE wrote the first draft of the manuscript. LW and EWS did the data analyses. EWS, LW, PJKvD and LYK had full access to and verified the underlying data. All authors helped to revise the manuscript for important intellectual content and had final responsibility for the decision to submit for publication.
Funding This study was supported by ZonMw (The Netherlands Organisation for Health Research and Development, grant 10430072010007).
Disclaimer The sponsor had no role in the design, analyses or reporting of the study.
Competing interests FE and TWK report (governmental) grants from ZonMw to studyimmune response after SARS-Cov-2 vaccination in autoimmune diseases. FE also reports grants from Prinses Beatrix Spierfonds, CSL Behring, Kedrion, Terumo BCT, Grifols, Takeda Pharmaceutical Company, and GBS-CIDP Foundation; consulting fees from UCB Pharma and CSlBehring; and honoraria from Grifols. AJvdK reports grants from CSLBehring and participation on an advisory board for Argen-X. ML reports agrant from Galapagos not related to this study, and honoraria from BristolMyers Squibb, Pfizer, Takeda and Tillotts. PIS is involved in clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of, for example, psoriasis and atopic dermatitis, for which financial compensation is paid to the department or hospital, and is achief investigator of the TREAT NL registry taskforce and SECURE-AD registry. MWB is a secretary for the Dutch Experimental Dermatology Board; head of the pigmentary disorders group within the Dutch Dermatology Board; and reports honoraria from Pfizer, Sanofi, Novartis, and Fondation René Touraine. JK has speaking relationships with MerckSerono, Biogen Idec, TEVA, Sanofi, Genzyme, Roche and Novartis; received financial support to his institution for researchactivities from Merck Serono, Bayer Shcering Pharma, Biogen Idec, GlaxoSmithKline (GSK), Roche, Teva, Sanofi, Genzyme and Novartis. BH reports unpaid positions as a medical adviser for several patient groups, aboard position for ERN-SKIN, and associate editor for The British Journalof Dermatology; reports grants from AbbVIe, Akari Therapeutics, Celgene and Novartis; consulting fees from UCB Pharma, Novartis, and Janssen; and honoraria from AbbVie. JJGMV reports consulting fees from Argenx, Alexion and NMD Pharma, and is a coinventor on patent applicationsbased on MuSK-related research. DJH reportsgrants from AbbVie, AstraZeneca, Janssen, LEO Pharma and UCB; honoraria from AbbVie, Galderma, Janssen, Lilly, Pfizer, Sanofi, and UCB; and a paid position on an advisory board for BIOMAP IMI. PAvD participated on an advisory board for Octapharma. PvP reports grantsfrom Alexion Pharma and GSK, and participation on advisory boards for GSK and Vifor Pharma. GRAMD’H reports consulting fees from AbbVie, Agomab, AstraZeneca, AM Pharma, AMT, Arena Pharmaceuticals, BristolMyers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, ExeliomBiosciences, Exo Biologics, Galapagos, Index Pharmaceuticals, Kaleido, Roche, Gilead, GSK, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Origo, Polpharma, Procise Diagnostics, Prometheus Laboratories, Prometheus Biosciences, Progenity and Protagonist; honoraria from AbbVie, Arena, Galapagos, Gilead, Pfizer, Bristol MyersSquibb and Takeda; and participation on advisory boards for AbbVie, Seres Health, Galapagos, and AstraZeneca. RBT reports honoraria fromSobi and Norgine, and participation on an advisory board for Norgine. SHG is a board member of the Dutch Society of Clinical Neurophysiology (unpaid), reports grants from Prinses Beatrix Spierfonds, and receivedspeaker fees from Shire/Takeda. KAHZ reports paid data safetymonitoring board positions for Torrent and Foresee.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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