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Abstract Number: 0437

Factors Associated with Reduced Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Patients with Autoimmune Inflammatory Rheumatic Diseases (AIIRD) Treated with Rituximab

Victoria Furer1, Tali Eviatar2, Devy Zisman3, Hagit Peleg4, Daphna Paran5, David Levartovsky1, Ilana Kaufman6, Michael Zisapel1, Ofir Elalouf7, Roni Meidan1, Adi Broyde8, Ari Polachek9, Jonathan Wollman7, Katya Meridor10, Hila Nochomovitz1, Adi Silberman1, Dana Rosenberg1, Joy Feld11, Amir Haddad12, Tal Gazitt13, Muna Elias3, Nizar Hijaze14, Fadi Kharouf4, Gabi Shefer1, Orly Sharon1, Sara Pel1, Sharon Nevo1 and Ori Elkayam15, 1Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, 2Tel Aviv Sourasky Medical Center, Givataim, Israel, 3Carmel Medical Center, Haifa, Israel, 4Hadassah Medical Center, Jerusalem, Israel, 5Tel Aviv Sourasky Medical Center-Ichilov Hospital, Even Yehuda, Israel, 6Tel Aviv Sourasky Medical Center, Petach Tiqwa, Israel, 7Tel Aviv Medical Center, Herzliya, Israel, 8Tel Aviv Sourasky Medical Center, KIBBUTZ GIVAT HAIM I, Israel, 9Sourasky Medical Center, Petah-Tikva, Israel, 10Tel Aviv Sourasky Medical Center, Kfar Saba, Israel, 11Carmel and Zvulun Medical Centre, Haifa, Israel, 12Carmel Medical Centre, Haifa, Israel, 13Carmel Hospital, Haifa, Israel, 14Carmel medical centre, Tamra, Israel, 15Tel Aviv Medical Center, Tel Aviv, Israel

Meeting: ACR Convergence 2021

Keywords: ANCA associated vasculitis, autoimmune diseases, COVID-19, immunology

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Session Information

Date: Saturday, November 6, 2021

Session Title: Abstracts: Immunological Complications of Therapy (0437–0440)

Session Type: Abstract Session

Session Time: 9:00AM-9:15AM

Background/Purpose: Rituximab (RTX) has been associated with impaired humoral response to vaccination. This study aim was to identify the predictors for a lack of humoral response to the BNT162b2 mRNA vaccine in patients with autoimmune inflammatory rheumatic diseases (AIIRD) treated with RTX.

Methods: We conducted a sub-analysis of the prospective multicenter study investigating immunogenicity of the two-dose regimen BNT162b2 mRNA vaccine in adult AIIRD patients, including rheumatoid arthritis (RA), systemic lupus erythematosus, systemic vasculitis, and inflammatory myositis treated with RTX compared to controls without rheumatic diseases or immunosuppressants use. Data on the serum IgG level prior to administration of the last course of RTX were collected. Post-vaccination serum IgG levels against SARS-CoV-2 spike S1/S2 proteins were measured 2 – 6 weeks after the 2nd vaccine dose. Seropositivity was defined as IgG ³15 binding antibody units (BAU)/ml.

Statistical analysis included a stepwise backward multiple logistic regression for predicting a seropositive result on AIIRD patients with all data available (n=92), starting with all individual variables showing the significance level < 0.2 between seropositive and seronegative result.

Results: A total of 98 AIIRD patients (75.5% females) and 122 controls (64.8% females) were included in the study (table 1). AIIRD patients were significantly older vs controls, mean±standard deviation (SD) 62.3±14.6 vs 50.8±14.6 years, p>0.0001, respectively. Among AIIRD patients, 4 had a past history of lymphoma. Following vaccination, the seropositivity rate and S1/S2 IgG levels (mean±SD) were significantly lower among AIIRD patients vs controls, 38.8% (n=38) vs 100%, p < 0.0001 and 49.9±81 vs 218.4±81.2 BAU/ml, p < 0.0001, respectively.

Seronegative and seropositive AIIRD patients treated with RTX significantly differed by the total number of RTX courses, mean 5.9±4.0 vs 3.9±3.2, p=0.012; IgG levels prior to administration of the last course of RTX, 880.4±306.8 vs 1233±624 mg/dl, p=0.0036 and the interval between the last RTX course and vaccination, 158.3±157.9 vs 410.6±459.7 days, p=0.0019 (table 2). Multivariate logistic regression predicting a seropositive response to vaccination in patients treated with RTX showed that RA conferred the highest probability for a positive response, while ANCA-associated vasculitis conferred the lowest probability for a positive response. The odds ratio (OR) of ANCA associated vasculitis was marginally significant (OR = 0.223, p=0.059). Two other variables –IgG level prior the last course of RTX and interval (days) between the last RTX course and vaccination – were associated with a seropositive response: for every 1 mg/dl IgG increment – OR 1.002, 95%CI 1-1.004, p=0.013, and for every day increment – OR 1.007, 95%CI 1.003-1.001, p=0.002, respectively. (table 3)

Conclusion: In AIIRD patients treated with RTX, high exposure to RTX over time, low IgG levels prior to the last RTX course, and a short interval between the last RTX course and BNT162b2 vaccination predicted the absence of a humoral response to vaccination. These data should guide the optimal timing of vaccination in patients treated with RTX.

AIIRD, autoimmune inflammatory rheumatic disease; n, number; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; ANCA, antineutrophil cytoplasmic antibody; IIM, idiopathic inflammatory myopathies; IgG, immune globulin G; SD, standard deviation; DAS28, disease activity score 28; SLEDAI, systemic lupus erythematosus disease activity index; PGA, patient global assessment; PhGA, physician global assessment; VAS, visual analogue scale; RTX, rituximab; IVIG, intravenous immune globulin.

RTX-subanalysis_ACR_2021-Table_2.jpeg”

* Fisher exact test p-value for the comparison between the relevant diagnosis (RA, SLE, etc.) and all other diagnoses
AIIRD, autoimmune inflammatory rheumatic disease; n, number; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; ANCA, antineutrophil cytoplasmic antibody; IIM, idiopathic inflammatory myopathies; IgG, immune globulin G; SD, standard deviation; RTX, rituximab; IVIG, intravenous immune globulin.

* Original model included SLE, ANCA associated vasculitis, other systemic vasculitis, IIM, disease duration, serum IgG levels, cumulative rituximab dose, rituximab last course dose, total rituximab courses, and time interval between the last rituximab course and BNT162b2 vaccine.
Including and staying criterion was p < 0.2. RA was considered as a reference for diagnosis.

RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; ANCA, antineutrophil cytoplasmic antibody; IIM, idiopathic inflammatory myopathies; IgG, immune globulin G; RTX, rituximab.


Disclosures: V. Furer, None; T. Eviatar, None; D. Zisman, None; H. Peleg, None; D. Paran, None; D. Levartovsky, None; I. Kaufman, None; M. Zisapel, None; O. Elalouf, None; R. Meidan, None; A. Broyde, None; A. Polachek, None; J. Wollman, None; K. Meridor, None; H. Nochomovitz, None; A. Silberman, None; D. Rosenberg, None; J. Feld, None; A. Haddad, None; T. Gazitt, None; M. Elias, None; N. Hijaze, None; F. Kharouf, None; G. Shefer, None; O. Sharon, None; S. Pel, None; S. Nevo, None; O. Elkayam, NOVARTIS, 1, 2, 6, Pfizer, 1, 2, 5, 6, Lilly, 1, 2, 6, Abbvie, 1, 6, BI, 1, 6.

To cite this abstract in AMA style:

Furer V, Eviatar T, Zisman D, Peleg H, Paran D, Levartovsky D, Kaufman I, Zisapel M, Elalouf O, Meidan R, Broyde A, Polachek A, Wollman J, Meridor K, Nochomovitz H, Silberman A, Rosenberg D, Feld J, Haddad A, Gazitt T, Elias M, Hijaze N, Kharouf F, Shefer G, Sharon O, Pel S, Nevo S, Elkayam O. Factors Associated with Reduced Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Patients with Autoimmune Inflammatory Rheumatic Diseases (AIIRD) Treated with Rituximab [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/factors-associated-with-reduced-immunogenicity-of-the-bnt162b2-mrna-covid-19-vaccine-in-patients-with-autoimmune-inflammatory-rheumatic-diseases-aiird-treated-with-rituximab/. Accessed February 6, 2023.
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