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Initial Serological Response after Prime-boost Pneumococcal Vaccination in Rheumatoid Arthritis Patients:Results of a Randomized Controlled Trial
- Source :
- Nguyen, M T T, Lindegaard, H, Hendricks, O, Jørgensen, C S, Kantsø, B & Friis-Møller, N 2017, ' Initial Serological Response after Prime-boost Pneumococcal Vaccination in Rheumatoid Arthritis Patients : Results of a Randomized Controlled Trial ', Journal of Rheumatology, vol. 44, no. 12, pp. 1794-1803 . https://doi.org/10.3899/jrheum.161407
- Publication Year :
- 2017
-
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 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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Randomization
Immunology
Pneumococcal Infections
law.invention
Disease-modifying
Arthritis, Rheumatoid
Pneumococcal Vaccines
Young Adult
03 medical and health sciences
0302 clinical medicine
Clinical trials
Rheumatology
Randomized controlled trial
law
Internal medicine
Clinical endpoint
medicine
Humans
Immunology and Allergy
030212 general & internal medicine
Dosing
Rheumatoid arthritis
Aged
Aged, 80 and over
030203 arthritis & rheumatology
Antirheumatic drugs
Biological Products
business.industry
Vaccination
Middle Aged
medicine.disease
Surgery
Clinical trial
Treatment Outcome
Pneumococcal vaccine
Antirheumatic Agents
Female
business
Immunosuppression
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Nguyen, M T T, Lindegaard, H, Hendricks, O, Jørgensen, C S, Kantsø, B & Friis-Møller, N 2017, ' Initial Serological Response after Prime-boost Pneumococcal Vaccination in Rheumatoid Arthritis Patients : Results of a Randomized Controlled Trial ', Journal of Rheumatology, vol. 44, no. 12, pp. 1794-1803 . https://doi.org/10.3899/jrheum.161407
- Accession number :
- edsair.doi.dedup.....421fa7e92106aa9a349e078bb69544b0