Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

Erasmus Medical Center128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Hidradenitis Suppurativa

Interventions

Wide ExcisionPROCEDURE

Wide excision is performed under general anaesthesia or procedural sedation and analgesia (PSA). All lesional tissue, including fibrosis, is electrosurgically removed until the area is clear. The subcutaneous fat and epithelised sinus floors are left intact where possible. The wounds are left open to heal by secondary intention.

Adalimumab InjectionDRUG

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 until end of study or last surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Cost-utility

Cost-utility: costs / point change in QALY

Time frame: 2 years

Secondary Outcomes

Clinical efficacy using HiSCR

Assessment of clinical efficacy using HiSCR

Time frame: 2 years

Clinical efficacy using change in HS-PGA

Assessment of clinical efficacy using change in HS-PGA

Time frame: 2 years

Clinical efficacy using the number of flares

Assessment of clinical efficacy using the overall number of flares

Time frame: 2 years

Incidence and severity of treatment related adverse events

Assessment of tolerability and safety by recording the incidence and severity of all treatment related adverse events.

Time frame: 2 years

Cost-effectiveness

Cost-effectiveness: costs / point change in DLQI.

Time frame: 2 years

Quality of life using change in EQ-5D-5L

Assessment of changes in quality of life using the EuroQol-5D-5L (EQ-5D-5L)

Time frame: 2 years

Quality of life using change in DLQI

Assessment of changes in quality of life using the DLQI.

Time frame: 2 years

Quality of life using change in Skindex-17

Central Contacts

Kelsey van Straalen, MD

CONTACT

+ 31 107040110 k.vanstraalen@eramsusmc.nl

Data from ClinicalTrials.gov

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