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. 2022 Dec;81(12):1757-1766.
doi: 10.1136/ard-2022-222904. Epub 2022 Sep 5.

Breakthrough infections with the SARS-CoV-2 omicron (B.1.1.529) variant in patients with immune-mediated inflammatory diseases

Eileen W Stalman #  1 , Luuk Wieske #  1   2 , Koos P J van Dam  1 , Laura Y Kummer  1   3 , Zoé L E van Kempen  4 , Joep Killestein  4 , Adriaan G Volkers  5 , Sander W Tas  6 , Laura Boekel  7 , Gertjan J Wolbink  8   9 , Anneke J Van der Kooi  1 , Joost Raaphorst  10 , Mark Löwenberg  5 , R Bart Takkenberg  5 , Geert R A M D'Haens  5 , Phyllis I Spuls  11 , Marcel W Bekkenk  12 , Annelie H Musters  12 , Nicoline F Post  12 , Angela L Bosma  12 , Marc L Hilhorst  13 , Yosta Vegting  13 , Frederique J Bemelman  13 , Alexandre E Voskuyl  14 , Bo Broens  15 , Agner Parra Sanchez  5   15 , Cécile A C M van Els  16   17 , Jelle De Wit  18   19 , Abraham Rutgers  20 , Karina de Leeuw  21 , Barbara Horváth  22 , Jan J G M Verschuuren  23 , Annabel M Ruiter  23 , Lotte van Ouwerkerk  24 , Diane van der Woude  25 , C F Allaart  26 , Onno Y K Teng  27 , Pieter van Paassen  28 , Matthias H Busch  29 , Papay B P Jallah  29 , Esther Brusse  30 , Pieter A van Doorn  30 , Adája Elisabeth Baars  30 , Dirk Jan Hijnen  31 , Corine R G Schreurs  31 , W Ludo Van der Pol  32 , H Stephan Goedee  32 , Maurice Steenhuis  3 , Sofie Keijzer  3 , Jim B D Keijser  3 , Arend Boogaard  3 , Olvi Cristianawati  3 , Anja Ten Brinke  3 , Niels J M Verstegen  3 , Koos A H Zwinderman  33 , Theo Rispens  8 , S Marieke van Ham  8 , Taco W Kuijpers  34 , Filip Eftimov  35 ; T2B! immunity against SARS-CoV-2 study group
Affiliations

Breakthrough infections with the SARS-CoV-2 omicron (B.1.1.529) variant in patients with immune-mediated inflammatory diseases

Eileen W Stalman et al. Ann Rheum Dis. 2022 Dec.

Abstract

Objectives: To compare the cumulative incidence and disease severity of reported SARS-CoV-2 omicron breakthrough infections between patients with immune-mediated inflammatory diseases (IMID) on immunosuppressants and controls, and to investigate determinants for breakthrough infections.

Methods: Data were used from an ongoing national prospective multicentre cohort study on SARS-CoV-2 vaccination responses in patients with IMID in the Netherlands (Target-to-B! (T2B!) study). Patients wih IMID on immunosuppressants and controls (patients with IMID not on immunosuppressants and healthy controls) who completed primary immunisation were included. The observation period was between 1 January 2022 and 1 April 2022, during which the SARS-CoV-2 omicron (BA.1 and BA.2 subvariant) was dominant. A SARS-CoV-2 breakthrough infection was defined as a reported positive PCR and/or antigen test at least 14 days after primary immunisation. A multivariate logistic regression model was used to investigate determinants.

Results: 1593 patients with IMID on immunosuppressants and 579 controls were included. The cumulative incidence of breakthrough infections was 472/1593 (29.6%; 95% CI 27% to 32%) in patients with IMID on immunosuppressants and 181/579 (31.3%; 95% CI 28% to 35%) in controls (p=0.42). Three (0.5%) participants had severe disease. Seroconversion after primary immunisation (relative risk, RR 0.71; 95% CI 0.52 to 0.96), additional vaccinations (RR 0.61; 95% CI 0.49 to 0.76) and a prior SARS-CoV-2 infection (RR 0.60; 95% CI 0.48 to 0.75) were associated with decreased risk of breakthrough infection.

Conclusions: The cumulative incidence of reported SARS-CoV-2 omicron breakthrough infections was high, but similar between patients with IMID on immunosuppressants and controls, and disease severity was mostly mild. Additional vaccinations and prior SARS-CoV-2 infections may reduce the incidence of breakthrough infections.

Keywords: Autoimmune Diseases; Autoimmunity; Covid-19; Vaccination.

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Conflict of interest statement

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, andGBS-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 trialswith many pharmaceutical industries that manufacture drugs used for thetreatment of, for example, psoriasis and atopic dermatitis, for whichfinancial compensation is paid to the department or hospital, and is achief investigator of the TREAT NL registry taskforce and SECURE-ADregistry. MWB is a secretary for the Dutch Experimental DermatologyBoard; head of the pigmentary disorders group within the DutchDermatology 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. BHreports 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 co-inventor 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. PAvDparticipated on an advisory board for Octapharma. PvP reports grantsfrom Alexion Pharma and GSK, and participation on advisory boards forGSK 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 andJohnson, Origo, Polpharma, Procise Diagnostics, PrometheusLaboratories, 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. All other authorsdeclare no competing interests.

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