ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: L01

Immunogenicity of mRNA COVID-19 Vaccines at 4 and 12 Weeks Post Full Vaccination in Patients with Inflammatory Rheumatic Diseases

Catherine Raptis1, Diego Andrey2, Christoph Berger3, Axel Finckh2, Pierre Lescuyer2, Adrian Ciurea4, Tanja Maletic1, Christos Polysopoulos1, Myriam Riek1, Almut Scherer1, Kim Lauper2, Burkhard Moeller5, Judith Safford6, Sandra Schweizer7, Isabell von Loga1, Nicolas Vuilleumier8 and Andrea Rubbert-Roth9, 1SCQM Foundation, Zurich, Switzerland, 2Geneva University Hospital, Geneva, Switzerland, 3University Hospital Basel, Basel, Switzerland, 4University Hospital Zurich, Zrich, Switzerland, 5Inselspital - University Hospital Bern, Bern, Switzerland, 6RheumaCura Foundation, Zurich, Switzerland, 7Swiss League Against Rheumatism, Zurich, Switzerland, 8University Hospital of Geneva, Geneva, Switzerland, 9Kantonspital St Gallen, St.Gallen, Switzerland

Meeting: ACR Convergence 2021

Date of first publication: October 22, 2021

Keywords: , , , , ,

Session Information

Title: Late-Breaking Posters (L01 - L15)

Session Type: Poster Session D

Background/Purpose: Emerging evidence indicates that immunosuppressive therapies may result in reduced immunogenicity –and presumably reduced efficacy-  following vaccination with mRNA COVID-19 vaccines but long-term data is missing. In this prospective observational study, our aim was to longitudinally map the anti-S1 response to the mRNA COVID-19 vaccines up to 24 weeks post full vaccination in patients with inflammatory rheumatic diseases (IRDs) on different treatment regimens.

Methods: Since March 2021, adult patients included in the Swiss long-term observational registry for patients (SCQM) with rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis who were willing to receive an mRNA vaccine were eligible to participate in an observational follow-up study that included app-based questionnaires as well as self-collected capillary blood draws involving a finger prick at predefined time points (at baseline (before scheduled vaccination) and 4, 12, and 24 weeks post full vaccination). Samples were tested for IgG antibodies against the S1 domain of the spike protein of SARS-CoV-2 (anti-S1) using the EUROIMMUN ELISA kit.

Results: 912 patients were recruited and by 31 August 2021, 441 had provided eligible (collected within pre-defined timeframes, enough serum) samples at baseline, 4- and 12-week post second vaccine dose (table 1). TNFi treatment at baseline is associated with a decreased anti-S1 response compared to non DMARD treatment at 4 and 12 weeks after full vaccination, both in monotherapy (p < 0.01 and p < 0.0001, respectively) and in combination therapy (p < 0.0001 at both follow-ups) for SARS-CoV-2 naïve IRD patients. The effect of combination therapy compared to monotherapy on the antibody response is noted by the significant shift in distribution of the former compared to the latter (p < 0.05 at both follow-ups). Rituximab significantly affected the anti-S1 response compared to the non DMARD group at both follow-ups (p < 0.05) and 4/11 of rituximab-treated patients failed to seroconvert after a full mRNA COVID-19 vaccination. A significantly higher peak response and diminished decline in anti-S1 antibodies from 4 to 12 weeks post full vaccination are noted in SARS-CoV-2 recovered vs SARS-CoV-2 naïve patients (figure 2).

Conclusion: Our preliminary results demonstrate a significantly reduced anti-S1 response and kinetics following vaccination with an mRNA-based COVID-19 vaccine in patients with inflammatory rheumatic diseases and different immunomodulatory regimens. We are also able to show that, similar to non-IRD patients, previous SARS-CoV-2 infection results in a significantly higher anti-S1 response as well as diminished decline over time. Limitations of our study include the lack of a matched healthy control group and of data related to a vaccine-induced cellular immune response, and the inability to formally exclude asymptomatic COVID-19 infection. Further analysis will allow to assess the anti-S1 response at 24 weeks post full vaccination, with more covariates, including, treatment changes around the time of vaccination, age, and vaccine received.

Table 1. Patient demographics and clinical characteristics. RA = rheumatoid arthritis; axSpA = axial spondyloarthritis; PsA = psoriatic arthritis; UA = undifferentiated arthritis and others; non_DMARD = no prescribed medication or other medication; csDMARD = conventional synthetic disease-modifying antirheumatic drug; GC = glucocorticoids; TNFi = tumour necrosis factor inhibitor; JAKi = janus kinase inhibitor; other_bDMARD = interleukin inhibitors IL_1/IL-6/IL_17/IL_23; combination therapy = bDMARD with additional csDMARD and/or GC. The 20 patients receiving GCs are double counted (included in individual treatment groups and in the total GC group) so as to show the extend of GC use over the entire cohort.

Figure 1. The variation with time of anti-S1 antibodies post mRNA COVID_19 vaccination in SARS-CoV_2 naïve adult IRD patients as a function of treatment at baseline. Results are reported as a ratio (sample extinction/ calibrator extinction). Boxplot whiskers extend to 1.5*IQR. BL = baseline (sample taken on day before or on day of first vaccination, before vaccination); FV+4w = 4 weeks post full vaccination; FV+12w = 12 weeks post full vaccination. non_DMARD = no prescribed medication or other medication; csDMARD a/o GC = conventional synthetic disease-modifying antirheumatic drug and/or glucocorticoids; TNFi = tumour necrosis factor inhibitor; JAKi = janus kinase inhibitor; other_bDMARD = interleukin inhibitors IL_1/IL-6/IL_17/IL_23. Grey points: monotherapy; red points: combination therapy = bDMARD with additional csDMARD and/or GC. The dashed line indicates the cut-off (1.1), recommended by the assay manufacturer, above which the result is considered positive for the presence of anti-S1 antibodies. The assay saturates at a ratio of 10. Asterisks indicate p values corrected for multiplicity (Bonferroni-Holm) for the non-parametric Mann-Whitney test applied to examine the differences in the distributions of the non_DMARD group and each of the other treatment groups at the respective 4- and 12-week time points post full vaccination. Monotherapy vs combination therapy TNFi treatment was additionally compared. Only significant differences are shown: (*) p < 0.05; (**) p < 0.01; (***) p < 0.001; (****) p < 0.0001.

Figure 2. The variation with time of anti-S1 antibodies post mRNA COVID_19 vaccination in adult IRD patients depending on whether the patients had a history of SARS-CoV_2 infection. Boxplot whiskers extend to 1.5*IQR. BL = baseline (sample taken on day before or on day of first vaccination, before vaccination); FV+4w = 4 weeks post full vaccination; FV+12w = 12 weeks post full vaccination. The dashed line indicates the cut-off (1.1), recommended by the assay manufacturer, above which the result is considered positive for the presence of anti-S1 antibodies. The assay saturates at a ratio of 10. For each of the distributions at 4 and 12 weeks post full vaccination the non-parametric Mann-Whitney test was applied to examine the shift in location between the SARS-CoV_2 naïve and the SARS-CoV_2 recovered patients (p values are corrected for multiplicity (Bonferroni-Holm)).

C. Raptis, None; D. Andrey, None; C. Berger, None; A. Finckh, None; P. Lescuyer, None; A. Ciurea, None; T. Maletic, None; C. Polysopoulos, None; M. Riek, None; A. Scherer, None; K. Lauper, Pfizer, 2, 6, Viatris, 6, Celltrion, 6; B. Moeller, None; J. Safford, None; S. Schweizer, None; I. von Loga, None; N. Vuilleumier, None; A. Rubbert-Roth, None.

To cite this abstract in AMA style:

Raptis C, Andrey D, Berger C, Finckh A, Lescuyer P, Ciurea A, Maletic T, Polysopoulos C, Riek M, Scherer A, Lauper K, Moeller B, Safford J, Schweizer S, von Loga I, Vuilleumier N, Rubbert-Roth A. Immunogenicity of mRNA COVID-19 Vaccines at 4 and 12 Weeks Post Full Vaccination in Patients with Inflammatory Rheumatic Diseases [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/immunogenicity-of-mrna-covid-19-vaccines-at-4-and-12-weeks-post-full-vaccination-in-patients-with-inflammatory-rheumatic-diseases/. Accessed .

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