Adalimumab for the treatment of hs.

Rationale:
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease characterised by recurring painful abscesses and draining sinuses in the ano-genital-inguinal area and axillae, with a prevalence of 1%. The disease tends to be difficult to treat. TNF-alpha inhibitors have shown promising results in small groups of patients.

Primary Objective:
To determine the efficacy of clarithromycin plus adalimumab versus clarithromycin plus placebo adalimumab in patients with moderate to severe HS.

Secondary Objectives:


1. To determine the short-term side effects and tolerance of adalimumab for the treatment of HS;

2. To determine the duration of remission during follow-up. Defined as an increase of disease activity towards 50% or greater than the baseline HS score.

Study design:
Randomized double-blind single placebo controlled trial.

Study population:
Male/female patients older or 18 years of age with active, moderate to severe HS (Hurley stage 2 or Hurley stage 3)

Intervention:
The first group will receive current standard treatment or so called “gold standard” therapy in HS which is oral antibiotics by means of clarithromycin SR 1 gr a day orally and a placebo s.c. injection identical to adalimumab every other week for 6 months. A second group will receive clarithromycin SR 1 g a day orally and adalimumab s.c. 160 mg at week 0, 80 mg at week 2 and then every other week 40 mg for 6 months.

Main study parameters/endpoints:
The primary objective is to determine the efficacy of clarithromycin plus adalimumab versus clarithromycin plus placebo adalimumab in patients with moderate to severe HS (Hurley stage 2 or Hurley stage 3). Primary outcome measure for the disease activity will be the modified Sartorius HS score. In addition we will use the DLQI quality of life form, Skindex-29 and a VAS pain score and a VAS patient disease global assessment score. The outcome measures for the secondary objective are all side effects e.g. injection site reactions, infection rates, laboratory abnormalities, SAE’s and SUSARs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participants will be seen in 18 visits in total. The screening comprises o.a. a chest x-ray, a Mantoux test and a serum pregnancy test (woman). Six blood samples will be obtained. Participants will be asked to fill in the DLQI, Skindex-29 and VAS scores 9 times. Pictures will be taken on 11 occasions and the blood pressure measured 4 times. At every visit a short medical exam will be done and patients will be asked about possible side effects.

Adalimumab is a more effecient drug than oral claritromycin alone in the treatment of hidradenitis suppurativa.

0,5 year treatment and a 0,5 year follow-up.

The first group will receive current standard treatment or so called “gold standard” therapy in HS which is oral antibiotics by means of clarithromycin SR 1 gr a day orally and a placebo s.c. injection identical to adalimumab every other week for 6 months. A second group will receive clarithromycin SR 1 g a day orally and adalimumab s.c. 160 mg at week 0, 80 mg at week 2 and then every other week 40 mg for 6 months.