Clinicians conducting pneumococcal vaccination in patients with rheumatoid arthritis (RA) should take into consideration the type of RA treatment being used and offer early vaccination, according to the results of a recent randomized, controlled, parallel-group, open-label, phase 3 Danish clinical trial published in The Journal of Rheumatology.
The objective of the study was to evaluate initial serologic responses to the 13-valent protein-conjugated pneumococcal vaccine (PCV13) followed by the 23-valent polysaccharide pneumococcal vaccine (PPV23) in patients with RA being treated with biologic disease-modifying antirheumatic drugs (bDMARDs), based on dosing and intervals between immunizations.
Participants were randomly assigned at a 1:1:1 ratio to receive immunization with single-dose PCV13 followed by PPV23 after 16 or 24 weeks, immunization with double-dose PCV13 followed by PPV23 after 16 weeks, or single-dose PCV13 followed by PPV23 16 weeks later (for patients taking conventional synthetic [cs]DMARDs). Pneumococcal antibodies were collected before and 4 weeks after the administration of each vaccination.
The primary end point was responsiveness to ≥6 of 12 antipneumococcal antibody serotypes 4 weeks after the prime-boost vaccination series. Secondary end points included responsiveness to individual antipneumococcal antibody serotypes.
A total of 65 participants receiving bDMARD therapy and 35 participants receiving csDMARD therapy were evaluated. After PPV23 vaccination, 87% of study participants treated with bDMARDs and 94% of patients treated with csDMARDs achieved the primary end point (95% CI, 0.76-0.94, and 95% CI, 0.77-0.99, respectively). No significant difference in the primary end point was observed in the 3 groups.
The serologic response in patients treated with rituximab was 25% (95% CI, 0.04 to 0.96), compared with ≥89% in participants receiving bDMARD therapy with an alternate mode of action (anti–tumor necrosis factor-α, CTLA-4 [abatacept], or anti–interleukin-6).
The investigators concluded that, although early serologic response to prime-boost vaccination with PCV13 followed by PPV23 was similar in participants treated with bDMARDs vs csDMARDs, notable differences in response were observed according to the type of bDMARD therapy being used. They highly recommend providing vaccinations to patients with RA as early as possible, preferably prior to the initiation of immunosuppressive treatment, as bDMARD therapy may increase a person’s risk for pulmonary infections and delay the diagnosis due to possible masking of inflammatory symptoms.
Nguyen MTT, Lindegaard H, Hendricks O, Jørgensen CS, Kantsø B, Friis-Møller N. Initial serological response after prime-boost pneumococcal vaccination in rheumatoid arthritis patients: results of a randomized controlled trial [published online October 1, 2017]. J Rheumatol. doi:10.3899/jrheum.161407