Exact(54)
Four patients were admitted to the ICU on two separate occasions, for these patients one infusion of DAA was given on each admission, three survived, and the median interval between admissions was 17 months (range 7 to 23).
The cost of abatacept is dependent on dosage; the recommendend dosages for one infusion are 500 mg for patients <60 kg, 750 mg for patient between 60 to 100 kg, and 1 g for patients >100 kg.
The ensuing discussion, except for safety, will focus on 15 patients who received at least one infusion of the study drug and had at least one follow-up evaluation.
The intention-to-treat (ITT) population included all randomised patients who received at least one infusion of the study treatment; depending on the purpose of analysis, ITT patients initially randomised to placebo were excluded.
The use of FCM did indeed permit fewer infusions on a per patient basis, with a median of one infusion per patient to deliver 500 mg iron (mean dose was 821 mg iron administered in two infusions).
During a 12-week induction period, subjects received either one infusion with secukinumab 3 or 10 mg/kg, respectively, on Day 1 or 3 infusions of secukinumab 10 mg/kg on Days 1, 15 and 29 or respective placebo infusions and were followed up to Week 56 as described.
Similar(6)
One infusion-related grade 3 adverse event was registered but no dose modification was required.
One infusion-related reaction (grade 1) was reported in the 5.0 mg/kg/week multiple-dose group and resolved after treatment with antihistamine and temporary interruption of dosing.
Among ATIpos patients, 11 (52%) had at least one infusion-related reaction, as compared with only 1 (1%) in the ATIneg group.
In fact, only one infusion-related AE occurred in the 16 patients who switched to velaglucerase alfa over 1.2 4.1 years.
Twenty-five (32%) of 78 treated patients had at least one infusion-related reaction, with a higher occurrence among patients classified as positive for antibodies to infliximab (58%, 15/26; table 1).
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