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Treatment with adalimumab significantly reduced the signs and symptoms of AS at weeks 12 and 24.
Secondary endpoints evaluated the cellular and humoral immunogenicity of ADVAX at 0, 1, 2, and 4 weeks after each vaccination as well as at weeks 16, 24, 36, 48, and 56.
Evaluations were carried out at entry of study as well as at weeks 1, 3, and 6.
Change from baseline in plasma HIV-1 RNA levels was assessed at weeks 4, 8, 12, and 24 in all patients, as well as at weeks 32, 40 and 48 in patients who participated in the treatment extension phase.
Patient visits were planned at baseline and at weeks 2, 13, 25, 36 and 52 of the extension study, as well as at weeks 12 and 24 during the treatment-free follow-up.
Before application of the experimental diets as well as at weeks 4, 8, and 12 of the diets and at corresponding time points in control animals, 1.5 ml of EDTA-blood were obtained from the retroorbital plexus under light ether anesthesia for measurements of plasma prorenin, plasma active renin, ANG I, and plasma aldosterone concentrations.
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Blood samples were collected from facial vein before each immunization point as well as at week 10.
The predictive value of response at week 3 was shown to be nearly as good at day 4 as at week 1.
The PK analysis was based on all subjects of the PK subgroup with evaluable PK data at week 1 as well as at week 26.
Moreover, these beneficial effects were encountered as early as at week 4 and persisted throughout the follow-up period until week 24.
Significance was achieved as early as at week 2 with mottled hyperpigmentation, lentigines, irregular depigmentation and elastosis and had not plateaued by week 24.
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