Tag Archive: Adalimumab

Adalimumab results in high clinical response rates for HS

In a recent study, researchers found that the groups receiving adalimumab (40 mg weekly) had significantly greater improvement than the placebo groups at week 12.

In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks. In period 2, patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks. The primary end point was a clinical response, defined as at least a 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in abscess or draining-fistula counts, at week 12

Treatment with adalimumab (40 mg weekly), as compared with placebo, resulted in significantly higher clinical response rates in both trials at 12 weeks; rates of serious adverse events were similar in the study groups.

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Adalimumab (Humira) approved by NICE for NHS use

Adalimumab (Humira) has been approved by NICE for NHS use in the UK for people with active moderate to severe Hidradentitis.

This comes after the medicine was approved for use in the EU in 2015.

The NHS will pay a reduced price for the drugs after a discount was agreed between the company and the Department of Health.

FDA approves Humira for Hidradenitis Suppurativa

The US Food and Drug Administration (FDA) has approved Humira for use on moderate to severe Hidradenitis Suppurativa. Humira is the first approved treatment for Hidradenitis Suppurativa.

The approval comes after the EU approved Humira in July 2015 for use on Hidradenitis Suppurativa.

EU approves Humira for Hidradenitis Suppurativa

AbbVie’s Humira has gained an EU licence to be used for treating patients with moderate to severe Hidradenitis Suppurativa. The approval is based on the results of two 36-week, two-period pivotal Phase III studies in 633 people with moderate to severe HS.

This is the first approved treatment for Hidradenitis Suppurativa.

Humira (Adalimumab) for Hidradenitis Suppurativa gets positive opinion in Europe

Biopharmaceutical firm AbbVie’s Humira (adalimumab) has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat adults with moderate to severe hidradenitis suppurativa.

This positive opinion is based on the results of two Phase 3 studies (PIONEER I and PIONEER II). Patients treated with Humira (adalimumab) 40 mg weekly beginning at week 4 following a 160 mg dose at week 0 and an 80 mg dose at week 2, showed a significantly greater response at week 12 versus those on placebo.

If the European Commission grants approval, Humira (adalimumab) will become the first medication approved for hidradenitis suppurativa in all 28 member states of the European Union, as well as in Iceland, Norway and Lichtenstein.