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Effectiveness of SARS-CoV-2 vaccination program in systemic sclerosis patients treated by autologous haematopoietic stem cell transplantation: a comparative study on behalf of MATHEC-SFGM-TC group
L. Biard1, G. Pugnet2, C. Cacciatore3, P.H. Prata4, B. Crichi5, F. Urbain6, I. Munia7, P. Lansiaux8, C. Le Maignan9, D. Farge10
- SBIM, Hôpital Saint Louis, APHP, Paris; and Université Paris Cité, IRSL, ECSTRRA UMR1342, Paris, France. lucie.biard@u-paris.fr
- Department of Internal Medicine and Clinical Immunology, CHU Rangueil, Toulouse, France.
- Internal Medicine Unit (UF04), CRMR MATHEC, Maladies Auto-Immunes et Thérapie Cellulaire, Centre de Référence des Maladies Auto-Immunes Systémiques Rares d’Ile-de-France, AP-HP, St. Louis Hospital, Paris, France.
- Haematology and Cellular Therapy Department, CHU de Limoges, France.
- Division of Internal Medicine (UF07), AP-HP, St-Louis Hospital, Paris, France.
- Department of Internal Medicine, AP-HP, Kremlin Bicêtre Hospital, Paris, France.
- Internal Medicine Unit (UF04), CRMR MATHEC, Maladies Auto-Immunes et Thérapie Cellulaire, Centre de Référence des Maladies Auto-Immunes Systémiques Rares d’Ile-de-France, AP-HP, St. Louis Hospital, Paris, France.
- Université Paris Cité, IRSL, ECSTRRA UMR1342, Paris; and Internal Medicine Unit (UF04), CRMR MATHEC, Maladies Auto-Immunes et Thérapie Cellulaire, Centre de Référence des Maladies Auto-Immunes Systémiques Rares d’Ile-de-France, AP-HP, St. Louis Hospital, Paris, France.
- Internal Medicine Unit (UF04), CRMR MATHEC, Maladies Auto-Immunes et Thérapie Cellulaire, Centre de Référence des Maladies Auto-Immunes Systémiques Rares d’Ile-de-France, AP-HP, St. Louis Hospital, Paris, France
- Université Paris Cité, IRSL, ECSTRRA UMR1342, Paris; Internal Medicine Unit (UF04), CRMR MATHEC, Maladies Auto-Immunes et Thérapie Cellulaire, Centre de Référence des Maladies Auto-Immunes Systémiques Rares d’Ile-de-France, AP-HP, St. Louis Hospital, Paris, France; and Department of Medicine, McGill University, Montreal, PQ, Canada.
CER18920
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PMID: 41537538 [PubMed]
Received: 15/05/2025
Accepted : 22/09/2025
In Press: 15/01/2026
Abstract
OBJECTIVES:
This study aimed to evaluate the effectiveness of the SARS-CoV-2 vaccination program in systemic sclerosis (SSc) patients treated by Autologous Hematopoietic Stem Cell Transplantation (AHSCT) compared to non-AHSCT SSc patients.
METHODS:
A French retrospective case-control study was conducted in SSc patients eligible for SARS-CoV-2 vaccination. AHSCT SSc (cases) were matched 1:1 with non-AHSCT SSc (controls) patients by age, sex, and disease duration. The primary endpoint was to assess the cumulative incidence of COVID-19 infection. Secondary objectives evaluated vaccination acceptance, the onset of severe adverse events after SARS-CoV-2 vaccination, the severity of COVID-19 infection and the serological response after vaccination or not.
RESULTS:
Seventy-two SSc patients (36 AHSCT 1:1 matched to 36 non-AHSCT, on age, sex, and disease duration on 1 January 2021) were included. The study showed a higher incidence of COVID-19 infection in AHSCT (p=0.007) versus non-AHSCT SSc patients, with respectively 11 out 36 cases and 2 out 36 controls contracting mild to moderate infections. The vaccine acceptance rate did not differ between AHSCT and non-AHSCT SSc patients, with respectively 5 out 36 cases and 3 out 36 controls who refused vaccination. No severe adverse event was reported after SARS-Cov-2 vaccination. Serological responses did not significantly differ between the two groups.
CONCLUSIONS:
The incidence of COVID-19 infection was higher in AHSCT-SSc compared to non-AHSCT SSc patients, with no difference in vaccine acceptance rate. COVID-19 vaccination in AHSCT highly fragile patients appeared to provide substantial COVID-19 protection, as shown by their favourable clinical evolution and effective humoral response.
