Anti-SARS-CoV-2 mRNA vaccine in patients with rheumatoid arthritis

Abstract

Anti-SARS-CoV-2 mRNA vaccine in patients with rheumatoid arthritisLong-term vaccine-induced immunity is crucial for controlling the COVID-19 pandemic. Vaccination against COVID-19 is recommended for patients with rheumatic diseases, but a paucity of data are available regarding COVID-19 vaccines in patients with rheumatoid arthritis. Because patients receiving immunosuppressive treatment were excluded from the phase 3 clinical trials, 1,2 it is not clear whether disease-modifying anti-rheumatic drug (DMARD) treatment should be continued before and after vaccination. In addition, some published reports are limited to follow-up after a single vaccine dose. [3][4][5] Here we report 53 consecutive patients with rheumatoid arthritis on DMARDs and 20 healthy controls (appendix p 1) who were eligible for vaccination according to the Swiss federal regulations and were enrolled in the RECOVER study, a non-randomised, prospective, observational trial. The RECOVER study was approved by the Ethical Committee of St Gallen, Switzerland, and written consent was obtained from all patients before inclusion. The vaccination itself was not part of the study. Nine patients received two doses of the mRNA-1273 vaccine (Moderna), all others received two doses of the BNT162b2 vaccine (Pfizer-BioNTech). Serum samples were collected at baseline, 3 weeks after the first vaccination, and 2 weeks after the second vaccination. Quantitative antibody testing was done using the Roche Elecsys Anti-SARS-CoV-2 spike subunit 1 (S1) assay that measures antibodies to SARS-CoV-2 spike protein 1 (range 0•4-2500 U/mL) and to SARS-CoV-2 nucleoprotein. This assay was used because it can distinguish between people who develop an anti-S1 response after vaccination or after natural infection, when typically antibodies to both S1 and nucleoprotein are generated. The threshold for this anti-SARS-CoV-2 S1 assay that might correspond to neutralisation of viral infectivity is still being discussed, but a cutoff level of 133 U/mL has been proposed. 6 A lower cutoff level of >15 U/mL has been suggested, 7 emphasising the need to establish formal cutoff levels of anti-SARS-CoV-2 antibody titres associated with protection against SARS-CoV-2 infection and severe disease.Intervals between the first and second vaccine dose and the intervals between vaccination and serum

Response to SARS-CoV-2 vaccination in immune mediated inflammatory diseases: Systematic review and meta-analysis

“…Out of this, data from 25 studies was used for analysis. Table 1 provides the details of the included studies including site of the study, numbers vaccinated in IMIDs, underlying disease and drugs, the number and type of vaccine received [ [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] ]. Supplementary Table 2 lists the reasons for exclusion of studies [ [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] ].…”

“… Antibodies against RBD were determined after second vaccination Response (29/74) IgG4-related (1/2) Connective tissue diseases (5/22), RA (13/33), Vasculitis (10/17). Control (10/10) Any csDMARD (16/42) MTX (10/24), MMF (2/8), HCQ (3/7, AZA (1/5), Leflunomide (2/4) SAAZ (1/1) Prednisone (8/22) Deepak P et al [ 27 ] (USA) 133 chronic inflammatory diseases 53 controls mean age 45.5 ± 16.0 years, Females ( n = 99) mRNA second dose IBD ( n = 43), Inflammatory arthritis (n = 2), RA ( n = 35), SpA (n = 6), SLE ( n = 13), Sjogren (n = 2), Psoriasis (n = 2), PsA (n = 5) anti-S IgG quantification was performed using ELISA and direct ex-vivo ELISpot assays were performed to quantify recombinant S protein-binding IgG secreting cells 96% of blood samples collected within 14 days post-vaccination Response (117/133), IBD (42/43), Inflammatory arthritis (2/2), RA (30/35), SpA (5/6), SLE (12/13), Sjogren (2/2), Psoriasis (1/2), PsA (5/5) Response in control (52/53) AZA (4/4), MMF (7/9), MTX (26/29), Leflunomide (2/2), Steroid (10/17), TNFi (35/38), Infliximab (6/6), Adalimumab (13/14), Golimumab (2/2), Abatacept (1/2), Vedolizumab (12/12), Ustekinumab (9/9), anti-IL 12/21 (10/10), Tofacitinib (10/10), Rituximab (5/6), anti- IL6(1/1), Rubbert-Roth et al [ 28 ] (Switzerland) 51 RA mean age 64·6 (11·5) years, Females ( n = 29) mRNA First dose second dose RA ( n = 51) Roche Elecsys Anti-SARS-CoV-2 spike subunit 1 (S1) A lower cutoff level of >15 U/mL has been suggested, emphasising the need to establish formal cutoff levels of anti-SARS-CoV-2 antibody titres associated with protection against SARS-CoV-2 infection and severe disease. Response in first dose (5/51), Second dose (45/51), RA (45/51) Control (20/20) csDMARD (13/16), MTX (24/28), Steroid (16/17), Biologicals (9/9), Abatacept(4/5), JAKi (4/5), Ruddy et al [ 29 ] (USA) ...…”

Efficacy and tolerability of a third dose of an mRNA anti-SARS-CoV-2 vaccine in patients with rheumatoid arthritis with absent or minimal serological response to two previous doses

“… 3 , 4 Lower seroconversion rates than in healthy controls have been reported in patients with rheumatic diseases receiving immunomodulatory therapies. 5 , 6 …”

Pausing drugs and spacing vaccines: an open question

“…We read with interest the Article by Andrea Rubbert-Roth and colleagues, 1 which reported that among 53 patients with rheumatoid arthritis on various biological, conventional synthetic, and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), antibody responses to COVID-19 vaccination was reduced compared with healthy controls.…”