Timeframe for Initiating Methotrexate and Vaccine Response Against Pneumococcus in Rheumatoid Arthritis: The VACIMRA Study

Jacques MOREL¹, Emmanuelle Dernis², christian roux³, Christophe Richez⁴, OLIVIER BROCQ⁵, Bruno Fautrel⁶, Carine SALLIOT⁷, Olivier Vittecoq⁸, Xavier Mariette⁹, Frédéric LIOTE¹⁰, Slim Lassoued¹¹, Cécile Gaujoux-Viala¹², Arnaud Constantin¹³, MArtin Soubrier¹⁴, Valerie Devauchelle¹⁵, Vincent Goeb¹⁶, Jacques-Eric Gottenberg¹⁷, Hubert Marotte¹⁸, Annouc Rémy Moulard¹, Corinne Merle de Boever¹, Héléna Huguet¹, Odile Launay¹⁹, Florence Galtier¹ and Marie Christine Picot¹, and F-CRIN networks iREIVAC and CRI-IMMIDIATE, ¹CHU and University of Montpellier, Montpellier, France, ²CH LE MANS, LE MANS, Pays de la Loire, France, ³rheumatology department, university Cote d'Azur, nice, France, ⁴Université de Bordeaux, Bordeaux, France, ⁵Service de Rhumatologie, centre hospitalier Princesse-Grâce, Monaco, Monaco, ⁶INSERM, UMRS 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Sorbonne University – Assistance Publique-Hôpitaux de Paris, Département de Rhumatologie, Hôpital Pitié-Salpêtrière, Paris, Ile-de-France, France, ⁷CHU and University of Orléans, Orléans, France, ⁸CHU and University of Rouen, Rouen, France, ⁹Service de Rhumatologie, Hôpital Bicêtre, AP-HP, Le Kremlin Bicetre, France, ¹⁰CHU and University of Paris Nord, Paris, France, ¹¹CH of Cahors, Cahors, France, ¹²CHU Nîmes, Nïmes, Languedoc-Roussillon, France, ¹³Hôpitaux de Toulouse, Toulouse, France, ¹⁴Gabriel-Montpied Hospital, Clermont-ferrand, France, ¹⁵UBO, Brest, France, ¹⁶CHu and University of Amiens, Ameins, France, ¹⁷Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ¹⁸Université Jean Monnet, CHU Saint-Etienne, Mines Saint-Etienne, INSERM SAINBIOSE 1059, Saint-Etienne, France, ¹⁹Centre d’Investigation Clinique en Vaccinologie (CIC Cochin Pasteur), Hôpital Cochin, Paris, Ile-de-France, France

Meeting: ACR Convergence 2024

Keywords: immunology, Infection, prevention, rheumatoid arthritis

Session Information

Date: Tuesday, November 19, 2024

Title: Abstracts: RA – Treatment II: Refining Use of Established Therapies

Session Type: Abstract Session

Session Time: 11:00AM-12:30PM

Background/Purpose: Pneumococcal vaccination is recommended for patients with chronic inflammatory rheumatism treated with immunosuppressants. Methotrexate (MTX) is the first-line treatment used in rheumatoid arthritis (RA), but can decrease the immune response of anti-pneumococcal vaccination in RA patients. It is recommended to vaccine before initiation of MTX but it is also recommended to start MTX as soon as the diagnosis of RA is made. How to manage vaccination in RA patients initiating MTX?

Methods: RA patients (ACR/EULAR 2010 criteria) were vaccinated with PCV13 at randomization and two months later with 23-valent pneumococcal polysaccharide vaccine (PPV23). Ig G concentrations of the 13 serotypes contained in PCV13 were measured at baseline and during follow-up at 1, 3, 6 and 12 months. After randomization 1:1, MTX was initiated immediately in GI or at one month in GD. Oral steroids were allowed but less than 10mg/day. Disease activity, infections and side effects were collected throughout the study. Outcomes were serotype-specific IgG concentrations of the 13 pneumococcal serotypes contained in PCV13 using ELISA and functional antibody activity using an opsonophagocytic killing assay (OPA), reported as the opsonisation indices (OIs). Positive antibody response was defined as ≥ 2-fold increase in the IgG concentration by ELISA. For OI, response was defined as a value ≥ to the serotype threshold provided by the laboratory. Main outcome was the responder rates at one month after PCV13, defined by at least 3 positives antibody responses out of 5 of the target serotypes (1, 3, 5, 7F, 19A) by ELISA or OPA. The main analysis was performed in the full analysis set (FAS) with a logistic mixed model.

Results:

276 RA patients were randomized. For the primary end point, data of 249 patients were analyzed in FAS. Characteristics of the RA patients at baseline were similar between the two groups: 70% female, mean age 55.6 years, RA duration 2 months, 69% ACPA+, 21% erosive, DAS28-CRP 4.6. Compared to GI, the rates of responders were significantly higher in GD : 88% versus 75% (p< 0.01) and 96% versus 88% (p=0.02) by ELISA and OPA respectively. The proportions of responders at 12 months were still higher in GD with ELISA. Evolution of geometric mean concentrations during the year of follow-up were higher for 8 out 13 serotypes in GD compared to GI. The cumulative doses of steroids and use of targeted DMARDs at 1 year were comparable between the two groups. There were similar proportions of severe infections during follow-up between groups. There were no unexpected side effects observed with PCV13 and PPV23. Beyond the 1st month, DAS28 scores were similar between the two groups. Predictive factors of response to pneumococcal vaccine will be presented.

Conclusion: This study clearly demonstrates that in RA, PCV13 vaccine administered 1 month prior starting MTX, allows a significantly higher immunological response at 1 month, in comparison to patients vaccinated simultaneously with MTX. The proportions of responders were also significantly higher in GD at 1 year with no differences on disease control and treatments used for RA such as glucocorticoids or tDMARDs. These results strongly support to vaccinate patients before MTX initiation

Disclosures: J. MOREL: None; E. Dernis: AbbVie/Abbott, 2, Amgen, 2, Boehringer-Ingelheim, 2, Celgene, 2, Eli Lilly, 2, Galapagos, 2, Gilead, 2, Janssen, 2, Merck/MSD, 2, Nordic Pharma, 2, Novartis, 2, Pfizer, 2, Roche, 2, roche-chugaï, 2, Sandoz, 2, Sanofi, 2, UCB, 2; c. roux: None; C. Richez: Abbvie, Astra Zeneca, BMS, GSK, Lilly, Novartis, Pfizer, UCB, 6, Lilly and Biogen, 5; O. BROCQ: None; B. Fautrel: AbbVie, 2, 5, Amgen, 2, Biogen, 2, BMS, 2, Celgene, 2, Celltrion, 2, Chugai, 2, Fresenius Kabi, 2, Galapagos, 2, Janssen, 2, Lilly, 2, 5, Medac, 2, MSD, 2, 5, Mylan, 2, Nordic Pharma, 2, Novartis, 2, Pfizer, 2, 5, Roche, 2, Sandoz, 2, Sanofi-Genzyme, 2, Sobi, 2, UCB, 2; C. SALLIOT: None; O. Vittecoq: None; X. Mariette: Bristol-Myers Squibb(BMS), 2, Galapagos, 2, GlaxoSmithKlein(GSK), 2, Novartis, 2, Pfizer, 2; F. LIOTE: None; S. Lassoued: None; C. Gaujoux-Viala: AbbVie/Abbott, 2, Alfasigma, 2, Amgen, 2, Boehringer-Ingelheim, 2, Bristol-Myers Squibb(BMS), 2, Celgene, 2, Eli Lilly, 2, Galapagos, 2, Gilead, 2, Janssen, 2, Medac, 2, Merck-Serono, 2, Mylan, 2, Nordic Pharma, 2, Novartis, 2, Pfizer, 2, Roche, 2, Sandoz, 2, Sanofi, 2, UCB, 2, Viatrix, 2; A. Constantin: None; M. Soubrier: None; V. Devauchelle: AbbVie, 2, BMS, 2, 5, Chugai, 5, Galapagos, 2, Janssen, 2, Lilly, 2, 5, Novartis, 2, Pfizer, 2; V. Goeb: None; J. Gottenberg: AbbVie, 2, BMS, 2, 5, Galapagos, 2, Gilead, 2, Lilly, 2, MSD, 2, Novartis, 2, Pfizer, 2, 5; H. Marotte: AbbVie/Abbott, 4, 5, 6, Biogen, 5, 6, Bristol-Myers Squibb(BMS), 5, 6, Celltrion Healthcare, 5, 6, Eli Lilly, 5, 6, Fresenius Kabi, 5, 6, Galapagos, 5, 6, Janssen, 5, 6, Merck/MSD, 5, 6, Nordic Pharma, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Roche, 5, 6, Sanofi, 5, 6; A. Rémy Moulard: None; C. Merle de Boever: None; H. Huguet: None; O. Launay: None; F. Galtier: None; M. Picot: None.

To cite this abstract in AMA style:

MOREL J, Dernis E, roux c, Richez C, BROCQ O, Fautrel B, SALLIOT C, Vittecoq O, Mariette X, LIOTE F, Lassoued S, Gaujoux-Viala C, Constantin A, Soubrier M, Devauchelle V, Goeb V, Gottenberg J, Marotte H, Rémy Moulard A, Merle de Boever C, Huguet H, Launay O, Galtier F, Picot M. Timeframe for Initiating Methotrexate and Vaccine Response Against Pneumococcus in Rheumatoid Arthritis: The VACIMRA Study [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/timeframe-for-initiating-methotrexate-and-vaccine-response-against-pneumococcus-in-rheumatoid-arthritis-the-vacimra-study/. Accessed .

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