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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation
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To: Icebrg who wrote (329)1/22/2003 8:23:49 PM
From: Miljenko Zuanic  Read Replies (1) of 631
 
From label:

Drug Interactions
MTX reduced adalimumab apparent clearance after single and multiple dosing by 29%
and 44% respectively.

Immunogenicity
Patients in Studies I, II, and III were tested at multiple time points for antibodies to
adalimumab during the 6 to 12 month period. Approximately 5% (58 of 1,062) of adult
rheumatoid arthritis patients receiving HUMIRA developed low-titer antibodies to
adalimumab at least once during treatment, which were neutralizing in vitro. Patients
treated with concomitant MTX had a lower rate of antibody development than patients on
HUMIRA monotherapy (1% versus 12%). No apparent correlation of antibody
development to adverse events was observed. With monotherapy, patients receiving
every other week dosing may develop antibodies more frequently than those receiving
weekly dosing. In patients receiving the recommended dosage of 40 mg every other
week as monotherapy, the ACR 20 response was lower among antibody-positive patients
than among antibody-negative patients. The long-term immunogenicity of HUMIRA is
unknown.
The data reflect the percentage of patients whose test results were considered positive for
antibodies to adalimumab in an ELISA assay, and are highly dependent on the sensitivity
and specificity of the assay. Additionally the observed incidence of antibody positivity in
an assay may be influenced by several factors including sample handling, timing of
sample collection, concomitant medications, and underlying disease. For these reasons,
comparison of the incidence of antibodies to adalimumab with the incidence of antibodies
to other products may be misleading.
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