Abstract
IntroductionThe efficacy of adalimumab, a fully human anti-tumor necrosis factor α recombinant antibody, has dramatically improved the quality of life of patients with rheumatoid and psoriatic arthritis and Crohn's disease. Because it is fully human, one should not expect immune reactions to this molecule. Adverse reactions to adalimumab are limited mainly to injection site reactions and are very common. Immediate systemic reactions are rarely reported.Case presentationWe report the case of a 61-year-old Caucasian woman who was treated with adalimumab for spondylarthritis and developed injection site reactions after the sixth dose. After a two-month suspension, she recommenced therapy and experienced two systemic reactions. The first occurred after one hour with itching of the palms and soles and angioedema of the tongue and lips. Thirty minutes after the next dose the patient had itching of the palms and soles with diffusion to her whole body, angioedema of the lips, dizziness and visual disturbances. A skin-prick test and intra-dermal tests with adalimumab gave strong positive results at the immediate reading. However, serum-specific immunoglobulin E (IgE) to adalimumab were not detectable by using Phadia solid phase, especially harvested for this case, in collaboration with our Immunology and Allergy Laboratory Unit. Her total IgE concentration was 6.4 kU/L.ConclusionWe describe what is, to the best of our knowledge, the first reported case of immediate systemic reaction to adalimumab studied with a skin test giving positive results and a serum-specific IgE assay giving negative results. The mechanism of the reaction must be immunologic but not IgE-mediated.
Highlights
The efficacy of adalimumab, a fully human anti-tumor necrosis factor a recombinant antibody, has dramatically improved the quality of life of patients with rheumatoid and psoriatic arthritis and Crohn’s disease
Case presentation: We report the case of a 61-year-old Caucasian woman who was treated with adalimumab for spondylarthritis and developed injection site reactions after the sixth dose
We describe what is, to the best of our knowledge, the first reported case of immediate systemic reaction to adalimumab studied with a skin test giving positive results and a serum-specific immunoglobulin E (IgE) assay giving negative results
Summary
To the best of our knowledge, the first case of an immediate systemic reaction to adalimumab with positive skin tests and negative research into serum-specific IgE, despite a comprehensive serologic study. The finding of positive skin tests suggests that an immunologic mechanism is responsible for this adverse reaction; serum-specific IgE to adalimumab could not be demonstrated by means of Phadia ImmunoCAP. The clinical consequences of this finding are limited, because the cases of adverse systemic reactions to adalimumab are rare. The conceptual implications of this case are highly relevant, because we demonstrated an adverse immune-mediated reaction to a fully human recombinant biologic response modifier, in this case and in some cases of injection site reactions to adalimumab. Consent Written informed consent was obtained from the patient for publication of this case report and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal
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