Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS (HS-COST)

Erasmus University

Status and phase: Unknown; Phase 4

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Adalimumab Injection; Procedure: Wide Excision

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03221621

HS-COST

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Adalimumab Monotherapy

Active Comparator group

Description:

Adalimumab injections will be administered through subcutaneously in a weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2, continued for 2 years in total.

Treatment:

Drug: Adalimumab Injection

Adalimumab + Surgery

Experimental group

Description:

Patients will be treated with a combination of adalimumab and wide excision, with a maximum of three surgical interventions within the first year. Adalimumab will be administered through subcutaneous injections in weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2, continued until the last surgery.

Treatment:

Procedure: Wide Excision

Drug: Adalimumab Injection