Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

Cost-effectiveness of Adalimumab With Adjuvant Surgery Versus Adalimumab Monotherapy in the Treatment of Hidradenitis Suppurativa'

The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy compared with the combination of adalimumab and a maximum of three surgeries after two years of treatment in adult patients with moderate to severe HS.

The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy (Group A) with the combination of adalimumab and a maximum of three surgeries (Group B) years of treatment in adult patients with moderate to severe HS.

Patients in group A will be treated with adalimumab monotherapy according to normal clinical practice and will be given the possibility to crossover into Group B when they do not achieve the HiSCR after 6 months of treatment. Additionally patients will be offered treatment with infliximab, according to clinical practice, until the last surgery. Patients in group B will receive adalimumab combined with a maximum of three adjuvant excisions of active lesions, both according to routine clinical practice.

Inclusion Criteria:

• Age ≥18 years.
• Moderate to (very) severe HS defined as a score of ≥3 points on the PGA (range 1-5) and with a DLQI of at least 11 (range 0-30).
• Indication for adalimumab: i.e. uncontrolled disease (HS) under conventional therapy and/or minor surgery.
• A diagnosis of HS for more than six months prior to baseline.
• Clearance of HS can reasonably be achieved with three surgical interventions as based on consensus between two dermatosurgeons.
• Willing and able to undergo general anaesthesia or procedural sedation and analgesia.
• Able and willing to give written informed consent and to comply with the study requirements.

Exclusion Criteria:

• Contraindication for treatment with adalimumab (sepsis or risk of sepsis, active or latent tuberculosis, serious active local and/or chronic infections, heart failure NYHA class III/IV, severe liver disease, pre-existing HIV, active viral hepatitis, demyelinating disease, or allergy to adalimumab or any other ingredients of HUMIRA®).
• Previous or current use of adalimumab or other anti-TNF-α therapy.
• Current or recurrent clinically significant skin condition in the HS treatment area other than HS.
• Presence of other uncontrolled clinically significant major disease.
• Pregnant and lactating women.
• Malignancy (except basal cell carcinoma), lymphoproliferative disease or a history of malignancy.
• Current use of oral antibiotics (a washout period of 14 days is required).
• Current use of oral corticosteroids (a washout period of 30 days is required).