Vaccine Responses in Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol: Results from a Single-blind Randomized Phase IV Trial.
ABSTRACT To evaluate the humoral immune response to pneumococcal and influenza vaccination in adults with rheumatoid arthritis (RA) receiving certolizumab pegol (CZP).
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.
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.
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.gov NCT00993668).
- SourceAvailable from: Helena H Askling[Show abstract] [Hide abstract]
ABSTRACT: International travel is increasing among a growing number of medically immunosuppressed patients regaining life-activity due to efficient drugs. Adequate pre-travel advice for this group of patients requires not only a travel-medicine expert but a relevant specialist as well, so that a personalized plan can be made concerning vaccinations and other prophylaxis. Inactivated vaccines can generally be prescribed during immunosuppressive therapy; the risk of inducing an exacerbation of the underlying disease is minimal and even though the post-vaccination antibody response will often be impaired, it will possibly benefit the patient by means of inducing a milder course of the disease. Live vaccines are generally contraindicated and if the risk of getting the disease in a particular country is high, the potential risks must be carefully discussed with the patient. It is essential to try to prevent infections in this group of patients who are more vulnerable to serious complications caused by the immunosuppression. The aim of this review was to summarize the available literature on immunosuppressive drug mechanisms and evidence on pre-travel-vaccinations, malaria prophylaxis as well as drugs preventing tourist diarrhea. The immunocompromised conditions/drugs used in these conditions that are covered include solid organ transplantations (SOT), hematopoietic stem cell transplantations, splenectomy, and chronic inflammatory diseases in adults. HIV and pediatric patient populations are not included.Travel Medicine and Infectious Disease 05/2014; · 1.54 Impact Factor
- The Journal of Rheumatology 04/2014; 41(4):626-8. · 3.17 Impact Factor