Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Adalimumab, a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF) has been shown to be safe and effective in juvenile idiopathic arthritis (JIA), and is approved for this use in several countries.1 Patients with JIA are candidates for routine childhood vaccinations. This post hoc report describes the observed use of vaccines in JIA patients receiving adalimumab for up to 3 years in a clinical trial setting.
Methods: Patients with active JIA were enrolled in one of the following trials: M10-444 (ages 2-4 or ≥ age 4 weighing <15 kg in US, EU), M10-240 (ages 4-17 in Japan), or DE038 (ages 4-17 in US, EU). Patients received treatment with ADA (weight-based dosing) every other week, either with or without methotrexate use. Any vaccinations administered were based on the judgment of the study investigators. Descriptive statistics were used to summarize all vaccinations, including influenza vaccine. Adverse events (AEs) related to active influenza virus infection were collected by a predefined MedDRA Query, and events occurring within 270 days of influenza vaccination were identified.
Results: A summary of all vaccinations is presented in the Table. Among the different types of vaccines, the most frequently administered were: influenza virus vaccine polyvalent in DE038 and M10-240 (n=59 and 63 vaccinations, respectively), and pneumococcal in M10-444 (n=28 vaccinations). In DE038 and M10-240, 2 patients each received >5 vaccinations and in M10-444, 10 patients received >5 vaccinations. The majority of vaccinated patients in each study received >1 type of vaccination. Among those who were never vaccinated for influenza, 12/137 patients (9%) in DE038, 1/5 patients (20%) in M10-240, and 2/28 patients (7%) in M10-444 reported influenza infection-related AEs. In those who received influenza vaccination, 4/34 patients (12%) in DE038, and 3/20 patients (15%) in M10-240 reported influenza infection-related AEs within 270 days of vaccination; none (0%) reported influenza infection-related AEs in M10-444.
Conclusion: These data support the idea that JIA patients treated with adalimumab can be safely immunized with routine, inactive, preventative vaccines, including influenza vaccine.
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Table. Summary of Vaccination Data Among JIA Patients |
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All Vaccinations |
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|
DE038 |
M10-240 |
M10-444 |
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Total patients vaccinated, n/N |
40/171 |
20/25 |
20/32 |
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Females vaccinated, % |
83 |
75 |
85 |
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Mean age, yrs (SD) |
12 (3.6) |
14 (3.3) |
3 (0.7) |
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Total vaccinations, n |
82 |
67 |
122 |
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Patients with >1 vaccination, n |
23 |
17 |
18 |
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Patients with >1 type of vaccination, n |
11 |
2 |
18 |
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Different types of vaccinations, n |
9 |
3 |
29 |
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Mean time to 1st vaccination, days |
714 |
187 |
96 |
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Mean age at 1st vaccination, yrsa |
13 |
14 |
3 |
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Mean JIA duration at 1st vaccination, yrsa |
NA |
4.5 |
1.02 |
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Influenza Vaccinations |
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|
DE038 |
M10-240 |
M10-444 |
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Total patients vaccinated, n/N |
34/171 |
20/25 |
4/32 |
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Females vaccinated, % |
79 |
75 |
75 |
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Total vaccinations, n |
59 |
63 |
6 |
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Patients with >1 vaccination, n |
17 |
17 |
1 |
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Mean time to 1st vaccination, days |
688 |
189 |
96 |
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NA=not available. aData for mean age at 1st vaccination and mean time to 1st vaccination are the same for “Influenza Vaccinations” for each study. |
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Reference: 1Lovell DJ, et al. NEJM 2008;359:810-820.
Disclosure:
N. Mozaffarian,
Abbott Laboratories,
1,
Abbott Laboratories,
3;
V. Arora,
Abbott Laboratories,
1,
Abbott Laboratories,
3.
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