Vaccine Responses in Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol: Results from a Single-blind Randomized Phase IV Trial
| Autor: | Marc de Longueville, Joy Schechtman, Elliot Chartash, Michele Texter, Andreas Fichtner, Alan Kivitz |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Influenza vaccine Immunology Antibodies Monoclonal Humanized Placebo Risk Assessment Gastroenterology Loading dose Polyethylene Glycols Arthritis Rheumatoid Pneumococcal Vaccines Immunoglobulin Fab Fragments Sex Factors Rheumatology Reference Values Internal medicine Confidence Intervals medicine Humans Immunology and Allergy Single-Blind Method Certolizumab pegol business.industry Vaccination Age Factors Middle Aged medicine.disease Immunity Humoral Treatment Outcome Pneumococcal vaccine Influenza Vaccines Concomitant Rheumatoid arthritis Antibody Formation Certolizumab Pegol Female Patient Safety business Immunosuppressive Agents Follow-Up Studies medicine.drug |
| Zdroj: | The Journal of Rheumatology. 41:648-657 |
| ISSN: | 1499-2752 0315-162X |
| Popis: | Objective.To evaluate the humoral immune response to pneumococcal and influenza vaccination in adults with rheumatoid arthritis (RA) receiving certolizumab pegol (CZP).Methods.In this 6-week, single-blind, placebo-controlled trial with optional 6-month open-label extension (NCT00993668), patients were stratified by concomitant methotrexate (MTX) use and randomized to receive CZP 400 mg (loading dose; according to CZP label) or placebo at weeks 0, 2, and 4. Pneumococcal (polysaccharide 23) and influenza vaccines were administered at Week 2. Satisfactory humoral immune response, defined as ≥ 2-fold titer increase in ≥ 3 of 6 pneumococcal antigens and ≥ 4-fold titer increase in ≥ 2 of 3 influenza antigens, were assessed independently 4 weeks after vaccination.Results.Following pneumococcal vaccination, 62.5% of placebo patients and 54.5% of CZP patients without effective titers at baseline achieved a humoral response (difference in proportions was −8.0 percentage points; 95% CI −22.5 to 6.6%). Following influenza vaccination, 61.4% of placebo and 53.5% of CZP patients without effective titers at baseline achieved a humoral response (difference in proportions: −8.0 percentage points; 95% CI −22.9 to 7.0%). In all patients, including those with effective titers at baseline, 58.2% of placebo and 53.3% of CZP patients developed satisfactory pneumococcal titers, and 54.1% of placebo and 50.5% of CZP patients developed satisfactory influenza antibody titers. Vaccine responses to pneumococcal and influenza antigens were reduced similarly in both treatment groups with concomitant MTX use.Conclusion.Humoral immune responses to pneumococcal and influenza vaccination are not impaired when given during the loading phase of CZP treatment in patients with RA. (ClinicalTrials.govNCT00993668). |
| Databáze: | OpenAIRE |
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