Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

Hidradenitis Suppurativa Clinical Trial

— HS-COST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221621
• Other study ID #: HS-COST
• Status: Recruiting
• Phase: Phase 4
• Start date: July 31, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2019
• Source: Erasmus Medical Center
• Contact: Kelsey van Straalen, MD
• Phone: + 31 107040110
• Email: k.vanstraalen[@]eramsusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a 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).

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Procedure:
• Wide Excision
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.

Drug:
• Adalimumab Injection
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.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Sanquin

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-utility	Cost-utility: costs / point change in QALY	2 years
Secondary	Clinical efficacy using HiSCR	Assessment of clinical efficacy using HiSCR	2 years
Secondary	Clinical efficacy using change in HS-PGA	Assessment of clinical efficacy using change in HS-PGA	2 years
Secondary	Clinical efficacy using the number of flares	Assessment of clinical efficacy using the overall number of flares	2 years
Secondary	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.	2 years
Secondary	Cost-effectiveness	Cost-effectiveness: costs / point change in DLQI.	2 years
Secondary	Quality of life using change in EQ-5D-5L	Assessment of changes in quality of life using the EuroQol-5D-5L (EQ-5D-5L)	2 years
Secondary	Quality of life using change in DLQI	Assessment of changes in quality of life using the DLQI.	2 years
Secondary	Quality of life using change in Skindex-17	Assessment of changes in quality of life using the Skindex-17	2 years
Secondary	Treatment satisfaction	Assessment of treatment satisfaction on a 5 point Likert scale	2 years
Secondary	High sensitivity CRP	Assessment of change in high sensitivity CRP.	2 years
Secondary	Cytokines	Assessment of cytokines as possible predictive biomarkers in skin biopsies.	3 months
Secondary	Change in parameters of metabolic syndrome	Assessment of the change in parameters of metabolic syndrome: waist circumference, blood pressure, fasting plasma glucose, triglycerides, and HDL levels.	2 years
Secondary	Change in parameters of pre-diabetes	Assessment of the change in parameters of pre-diabetes using a HOMA model	2 years
Secondary	Identification of blood metabolite profiles	Identification of metabolites or metabolite profiles related to HS phenotypes, disease severity.	3 months
Secondary	Identification of metabolites associated with treatment response	Identification of metabolites (or metabolite profiles) predicting clinical response to treatment.	3 months
Secondary	Assessment of changes in metabolite (profiles)	Assessment of changes in metabolites (or metabolite profiles) in response to treatment.	3 months
Secondary	Relation between adalimumab trough concentrations and treatment response	Relation between adalimumab trough concentrations and treatment response	3 months
Secondary	Relation between adalimumab trough concentrations in serum and skin samples	Relation between adalimumab trough concentrations in serum and adalimumab trough concentrations in skin biopsies.	3 months
Secondary	Influence of patient characteristics on adalimumab serum trough concentrations	adalimumab trough concentrations	3 months
Secondary	Predictive value of early dry-blood-spots	Predictive value of early adalimumab concentrations using dry-blood-spots on treatment response at 3 months	3 months
Secondary	Objectively assessed therapy adherence using adalimumab trough concentrations	Objectively assessed therapy adherence using adalimumab trough concentrations	2 years
Secondary	Objectively assessed therapy adherence using collected syringes	Objectively assessed therapy adherence using collected syringes	2 years
Secondary	Patient reported therapy adherence using a diary	Patient reported therapy adherence using a diary recording date of every injection.	2 years
Secondary	Impact of surgery on quality of life measured with DLQI	Assessment of the impact of wide excision on quality of life measured with DLQI	8 weeks after each surgery
Secondary	Impact of surgery on work productivity measured with WPAI	Assessment of the impact of wide excision on work productivity and activity, measured with WPAI.	8 weeks after each surgery
Secondary	Wound closure time	Assessment of time to complete healing after wide excision using patient reported closure time.	through study completion, an average of 15 months
Secondary	Recurrence rate	Assessment of the recurrence of HS lesions after wide excision	through study completion, an average of 15 months