Hidradenitis Suppurativa, Acne Inversa MedDRA version: 19.1 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Humira
Pharmaceutical Form:
Sponsors
Erasmus MC, Department of Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria: 1. Age =18 years. 2. 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). 3. Indication for adalimumab: uncontrolled disease (HS) under conventional therapy and/or minor surgery. 4. A diagnosis of HS for more than six months prior to baseline. 5. Clearance of HS can reasonably be achieved with three surgical interventions as based on consensus between two dermatosurgeons. 6. Willing and able to undergo general anaesthesia. 7. Able and willing to give written informed consent and to comply with the study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. 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®). 2. Previous or current use of adalimumab or other anti-TNF-a therapy. 3. Current or recurrent clinically significant skin condition in the HS treatment area other than HS. 4. Presence of other uncontrolled clinically significant major disease. 5. Pregnant and lactating women. 6. Malignancy (except basal cell carcinoma), lymphoproliferative disease or a history of malignancy. 7. Current use of oral antibiotics (a washout period of 14 days is required). 8. Current use of oral corticosteroids (a washout period of 30 days is required).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this prospective study is to evaluate the cost-utility of the combination of adalimumab and surgery compared to adalimumab monotherapy after two years of treatment in adult patients with moderate to severe hidradenitis suppurativa (HS).;Secondary Objective: -To assess cost-effectiveness per point change in DLQI. -To assess clinical efficacy and changes in quality of life. -To explore the effect on serum biomarkers and cytokine profile in skin. -To assess the tolerability and safety of both treatments. -To explore the effect on parameters of metabolic syndrome and pre-diabetes. -To assess the relation between metabolites, HS phenotypes/severity, and clinical response, and to assess changes in metabolites after treatment. -To assess the relation between adalimumab concentration and clinical response, between adalimumab concentration in serum and skin, between patients characteristics (including pharmacogenetics) and serum concentration, predictive value of early adalimumab concentrations on clinical response, and therapy adherence. -To assess the effect of surgery on quality of life, pain, prurigo, and work activity, and the influence of wound size, location, and patient characteristics on pain, work activity and healing time.;Primary end point(s): The main endpoint of this study is cost-utility of both treatment regimens, calculated as incremental cost utility ratio (ICUR) per QALY after 24 months. In order to calculate the ICUR following main parameters will be assessed during the study - Hospital costs, derived from the quantities of medication used, surgery, visits to health care professionals and hospitalizations. These costs will be collected using the hospital register. - Out of hospital costs (e.g. general practitioners visits and out of pocket payments by patients) as measured using the Medical Consumption Questionnaire (iMCQ). - Productivity losses, measured through the iMTA Productivity Cost Questionnaire (iPCQ). - | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): This study has the following secondary enpoints: - The cost-effectiveness of both treatment strategies after 24 months, expressed as the incremental cost-effectiveness ratio (ICER) per point improvement on the Dermatology Life Quality Index (DLQI). - The clinical efficacy of both treatment strategies after 24 months (and five years) using the, 5-point Physician global assessment (PGA), Hidradenitis Suppurativa Clinical Response score (HiSCR), and the amount of flares. - The changes in quality of life using the EuroQol-5D-5L (EQ-5D-5L), DLQI and Skindex-17 after 24 months and five years. - The effect of both treatment strategies on serum biomarkers after 24 months and cytokine profile in skin biopsies after three months. - The tolerability and safety of both treatment regimens after 24 months. - The treatment satisfaction three months after surgery and after 24 months for both treatment strategies. - The frequency of metabolic syndrome and pre-diabetes in patients with moderate to severe HS, and the effect of both treatment strategies on parameters of metabolic syndrome and pre-diabetes after 24 months. - The (blood) metabolite profile of HS patients, the relation between metabolites or metabolite profiles and HS phenotypes, disease severity and clinical response (at three months), and changes in metabolite profile after three months of treatment. - Pharmacokinetics of adalimumab; the relation between adalimumab serum trough concentrations and clinical response after three months, the relation between the trough concentration of adalimumab in serum and skin samples after three months, the influence of patient characteristics (including pharmacogenetics) on adalimumab serum trough concentrations at three and 24 months, the predictive value of early adalimumab trough concentrations on clinical response at three months, and objectively assessed and self-reported adherence to adalimumab after 24 months. - The effect of en bloc surgery on quality | — |
Countries
Netherlands
Contacts
Public ContactM.B.A. van Doorn
Erasmus MC, Department of Dermatology
Outcome results
None listed