Pneumococcal Vaccination in Patients with Systemic Lupus Erythematosus: A Multicenter Placebo-Controlled Randomized Double-Blind Study

Sophie Grabar¹, Matthieu Groh², Mathilde Bahuaud³, Nathalie Costedoat-Chalumeau⁴, Veronique Le Guern⁵, Renato Fior⁶, Boris Bienvenu⁷, eric hachulla⁸, Mohamed Hamidou⁹, Jean Sibilia¹⁰, Alexis Mathian¹¹, Thomas Hanslik¹², Loïc Guillevin for the French Vasculitis Study Group¹³, Frédéric Batteux³ and Odile Launay¹⁴, ¹Université Paris Descartes, Sorbonne Paris Cité AP-HP, Unité de Biostatistique et Epidémiologie, Groupe Hospitalier Cochin Broca Hôtel-Dieu, Paris, France; INSERM, UPMC Université Paris 06, Institut Pierre Louis d’épidémiologie et de Santé Publique (IP, Paris, France, ²National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, ³Université Paris Descartes, Sorbonne Paris Cité AP-HP, Département d’Immunologie Biologique, Groupe Hospitalier Cochin Broca Hôtel-Dieu, Paris, France, Paris, France, ⁴Service de médecine interne Pôle médecine, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares de l’île de France, Paris, France, ⁵Department of Internal Medicine, Department of Internal Medicine, Cochin University Hospital, Paris, France, ⁶Université Paris-Sud, AP-HP, Service de Médecine Interne et Immunologie Clinique, Hôpital Antoine Béclère, Clamart, France, Clamant, France, ⁷Internal Medicine, Hôpital de la côte de Nacre, Caen, France, ⁸chru lille hospital, lille, France, ⁹Medecine Interne, CHU Hôtel Dieu, Nantes, France, ¹⁰Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ¹¹Université Pierre et Marie Curie, Sorbonne Paris Cité AP-HP, Service de Médecine Interne 2, Centre de Référence National pour le Lupus et le Syndrome des Antiphospholipides, institut E3M, Paris, France, Paris, France, ¹²Université Versailles Saint-Quentin-en-Yvelines, APHP, Service de Médecine Interne, Hôpital Ambroise Paré, Boulogne-Billancourt, France, Boulogne-Billancourt, France, ¹³Service de Médecine Interne, Centre de Référence Maladies Auto-Immunes et Auto-Inflammatoires Systémiques Rares, Hôpital Cochin, Paris, France, ¹⁴Université Paris Descartes, Sorbonne Paris Cité AP-HP, Groupe Hospitalier Cochin Broca Hôtel-Dieu, Fédération d'Infectiologie, Paris, France; Inserm, F-CRIN I-REIVAC., Paris, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Infection, Respiratory disease, systemic lupus erythematosus (SLE) and vaccines

Session Information

Date: Tuesday, November 7, 2017

Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment Poster III: Therapeutics and Clinical Trial Design

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:

Invasive pneumococcal disease and respiratory tract infections are both frequent and severe in patients with systemic lupus erythematosus (SLE). This study aimed to compare the immunological efficacy and safety of pneumococcal vaccination with the 23-valent polysaccharide (PPS) vaccine alone to a sequential immunization with the 7-valent pneumococcal conjugate (PnCj) vaccine followed by PPS in patients with SLE and stable disease.

Methods:

Multicenter randomized placebo-controlled double-blind trial: PPS vaccine alone (placebo-PPS group) or PnCj vaccine followed by PPS vaccine (PnCj-PPS group) 24 weeks later. The primary endpoint was the rate of responders at week 28 to at least 5 of the 7 serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) shared by both PPS and PnCj. The response to each serotype was defined as both a two-fold increase between inclusion and week 28 of pneumococcal IgG antibody titers (ELISA) and an antibody titer ≥ 1 µg/mL at week 28. Pneumococcal IgG antibodies’ opsonophagocytic activity (OPA) was also assessed at baseline and at week 28, and the response to a specific serotype was defined by both ≥ four-fold increase of the opsonization index (OI, defined by the serum dilution killing 50% of the bacterial inoculum) between baseline and week 28,and an OI ≥ 8 at week 28.

Results:

Twenty-five patients in the placebo-PPS group and 17 in the PnCj-PPS group were included in a modified intention-to-treat analysis. The primary endpoint was reached in 72% (18/25) in the placebo-PPS and 76% (13/17) in the PnCj-PPS group (p = 0.75). There was no difference in the rates of responders with OPA. At week 52, 13/18 (72%) patients in the placebo-PPS group and 10/13 (77%) patients in the PnCj-PPS group (p=0.77) that met the primary endpoint at week 28 were still responders to ≥ 5/7 serotypes shared by both PPS and PnCj vaccines. Nine SLE flares were reported in 6 patients (4 in the placebo-PPS and 2 in the PnCj-PPS groups respectively, p=0.70).

Conclusion:

Sequential administration of PnCj vaccine followed by PPS vaccine is safe and shows short-term immunological efficacy in patients with SLE but was not superior to the PPS vaccine alone. Future studies with new vaccines and/or innovative schedule designs are warranted in order to better protect SLE patients against pneumococcal infections.

Disclosure: S. Grabar, None; M. Groh, Pfizer Inc, 2; M. Bahuaud, None; N. Costedoat-Chalumeau, None; V. Le Guern, None; R. Fior, None; B. Bienvenu, None; E. hachulla, None; M. Hamidou, None; J. Sibilia, None; A. Mathian, None; T. Hanslik, None; L. Guillevin for the French Vasculitis Study Group, None; F. Batteux, Pfizer, 2; O. Launay, Pfizer Inc, 2.

To cite this abstract in AMA style:

Grabar S, Groh M, Bahuaud M, Costedoat-Chalumeau N, Le Guern V, Fior R, Bienvenu B, hachulla E, Hamidou M, Sibilia J, Mathian A, Hanslik T, Guillevin for the French Vasculitis Study Group L, Batteux F, Launay O. Pneumococcal Vaccination in Patients with Systemic Lupus Erythematosus: A Multicenter Placebo-Controlled Randomized Double-Blind Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/pneumococcal-vaccination-in-patients-with-systemic-lupus-erythematosus-a-multicenter-placebo-controlled-randomized-double-blind-study/. Accessed .

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