Mai T T Nguyen1,2, Hanne Lindegaard3,4, Oliver Hendricks3,4, Charlotte Sværke Jørgensen3,4, Bjørn Kantsø3,4, Nina Friis-Møller3,4. 1. From the Department of Infectious Diseases, and Department of Rheumatology, and Odense Patient data Explorative Network (OPEN), Odense University Hospital; Institute of Clinical Research, University of Southern Denmark; Institute of Regional Research, University of Southern Denmark, Odense; Department of Rheumatology, King Christian Xth Hospital for Rheumatic Disease, Graasten; Department of Microbiology and Virology, Statens Serum Institut, Copenhagen; Unit of Infectious Diseases, Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark. mai.nguyen@rsyd.dk. 2. M.T. Nguyen, MD, Department of Infectious Diseases, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, and OPEN, Odense University Hospital; H. Lindegaard, MD, PhD, Institute of Clinical Research, University of Southern Denmark, and Department of Rheumatology, Odense University Hospital; O. Hendricks, MD, PhD, Department of Rheumatology, King Christian Xth Hospital for Rheumatic Disease, and Institute of Regional Research, University of Southern Denmark; C.S. Jørgensen, MSc, PhD, Department of Microbiology and Virology, Statens Serum Institut; B. Kantsø, MSc, PhD, Department of Microbiology and Virology, Statens Serum Institut; N. Friis-Møller, MD, DMSc, Department of Infectious Diseases, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, and Unit of Infectious Diseases, Department of Internal Medicine, Zealand University Hospital. mai.nguyen@rsyd.dk. 3. From the Department of Infectious Diseases, and Department of Rheumatology, and Odense Patient data Explorative Network (OPEN), Odense University Hospital; Institute of Clinical Research, University of Southern Denmark; Institute of Regional Research, University of Southern Denmark, Odense; Department of Rheumatology, King Christian Xth Hospital for Rheumatic Disease, Graasten; Department of Microbiology and Virology, Statens Serum Institut, Copenhagen; Unit of Infectious Diseases, Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark. 4. M.T. Nguyen, MD, Department of Infectious Diseases, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, and OPEN, Odense University Hospital; H. Lindegaard, MD, PhD, Institute of Clinical Research, University of Southern Denmark, and Department of Rheumatology, Odense University Hospital; O. Hendricks, MD, PhD, Department of Rheumatology, King Christian Xth Hospital for Rheumatic Disease, and Institute of Regional Research, University of Southern Denmark; C.S. Jørgensen, MSc, PhD, Department of Microbiology and Virology, Statens Serum Institut; B. Kantsø, MSc, PhD, Department of Microbiology and Virology, Statens Serum Institut; N. Friis-Møller, MD, DMSc, Department of Infectious Diseases, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, and Unit of Infectious Diseases, Department of Internal Medicine, Zealand University Hospital.
Abstract
OBJECTIVE: To evaluate the initial serological responses to pneumococcal vaccination with the 13-valent protein-conjugated pneumococcal vaccine (PCV13) followed by the 23-valent polysaccharide pneumococcal vaccine (PPV23) among patients with rheumatoid arthritis (RA) treated with biological disease-modifying antirheumatic drugs (bDMARD) according to dosing and intervals between immunizations. METHODS: Investigator-initiated clinical trial. Patients with RA receiving bDMARD were randomized (1:1:1) to immunization with single dose PCV13 followed by PPV23 after 16 or 24 weeks, or double dose PCV13 followed by PPV23 after 16 weeks. A comparison group of patients with RA treated withconventional synthetic (cs)DMARD received single dose PCV13 followed by PPV23 16 weeks later. Pneumococcal antibodies were collected before and 4 weeks after each vaccination. The primary endpoint was the proportion of participants responding to ≥ 6/12 pneumococcal serotypes 4 weeks after both vaccinations. RESULTS:Sixty-five participants receiving bDMARD and 35 participants receiving csDMARD were included. After PPV23 vaccination, 87% (95% CI 0.76-0.94) and 94% (95% CI 0.77-0.99), respectively, of participants treated with bDMARD and csDMARD had reached the primary endpoint. There was no significant difference in primary endpoint between the 3 randomization arms. The response for rituximab-treated participants was 25% compared to ≥ 89% in participants treated with bDMARD with other mode of action. CONCLUSION: The early serological response to prime-boost vaccination with PCV13 followed by PPV23 was very similar among participants receiving bDMARD and csDMARD. However, notable differences in response were observed according to individual bDMARD. It is important to consider the RA treatment when planning pneumococcal vaccination in patients with RA.
RCT Entities:
OBJECTIVE: To evaluate the initial serological responses to pneumococcal vaccination with the 13-valent protein-conjugated pneumococcal vaccine (PCV13) followed by the 23-valent polysaccharide pneumococcal vaccine (PPV23) among patients with rheumatoid arthritis (RA) treated with biological disease-modifying antirheumatic drugs (bDMARD) according to dosing and intervals between immunizations. METHODS: Investigator-initiated clinical trial. Patients with RA receiving bDMARD were randomized (1:1:1) to immunization with single dose PCV13 followed by PPV23 after 16 or 24 weeks, or double dose PCV13 followed by PPV23 after 16 weeks. A comparison group of patients with RA treated with conventional synthetic (cs)DMARD received single dose PCV13 followed by PPV23 16 weeks later. Pneumococcal antibodies were collected before and 4 weeks after each vaccination. The primary endpoint was the proportion of participants responding to ≥ 6/12 pneumococcal serotypes 4 weeks after both vaccinations. RESULTS: Sixty-five participants receiving bDMARD and 35 participants receiving csDMARD were included. After PPV23 vaccination, 87% (95% CI 0.76-0.94) and 94% (95% CI 0.77-0.99), respectively, of participants treated with bDMARD and csDMARD had reached the primary endpoint. There was no significant difference in primary endpoint between the 3 randomization arms. The response for rituximab-treated participants was 25% compared to ≥ 89% in participants treated with bDMARD with other mode of action. CONCLUSION: The early serological response to prime-boost vaccination with PCV13 followed by PPV23 was very similar among participants receiving bDMARD and csDMARD. However, notable differences in response were observed according to individual bDMARD. It is important to consider the RA treatment when planning pneumococcal vaccination in patients with RA.
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