Vaccine Responses in Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol: Results from a Single-blind Randomized Phase IV Trial
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).
Available from: Helena H Askling
- "The effect of abatacept on pneumococcal vaccination was investigated in healthy controls and showed a decreased antibody response . Neither certolizumab-pegol-nor tocilizumab-treated RA-patients had an impaired antibody response after pneumococcal polysaccaride vaccination  . This was also shown with the 7-valent conjugate vaccine for tocilizumab but the antibody response was impaired for the RApatients treated with abatacept or rituximab . "
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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.
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ABSTRACT: Certolizumab pegol (CZP) is a novel anti-TNF agent that is used for patients with moderate to severe active rheumatoid arthritis (RA). However, the efficacy of CZP in RA remains controversial. Thus, we performed this meta-analysis to assess the efficacy and safety of CZP in the treatment of RA patients.
Eligible studies were randomized controlled trials (RCTs) that evaluated the efficacy and safe of CZP in the patients with active RA. The primary outcome was American College of Rheumatology 20% (ACR20), and secondary outcome were ACR50, ACR70, disease activity, patient-reported outcomes (PROs), and adverse events. A fixed-effect model or random-effect model was used to pool the estimates, depending on the absence or presence of heterogeneity among the included studies.
Nine RCTs with a total of 5228 patients were included in this meta-analysis, and all of the patients were administered CZP or placebo. The pooled results showed that CZP significantly improved the ACR20, ACR50, ACR70 response rates, and physical function. CZP was associated with a statistically significant reduction in Disease Activity Score in 28 joints-Erythrocyte sedimentation rate, arthritis pain, and fatigue. Patients who received CZP treatment did not have a higher incidence of treatment-related adverse events, no matter in any intensity.
CZP 200 or 400mg in the treatment of active RA significantly reduced the RA signs and symptoms, and improved physical function as compared with the placebo. More large-scale RCTs are needed to evaluate the long-term efficacy and safety of CZP in the treatment of active RA.
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