Hidradenitis Suppurativa Patient Experience With Humira Treatment

Hidradenitis Suppurativa Patients' Experience of Treatment With Adalimumab

Hidradenitis suppurativa (HS) is a chronic relapsing condition with significant psychosocial impact and morbidity, but that doesn't mean that patients will necessarily be adherent to recommended treatments. Patients, especially those on chronic medication therapy, inevitably miss doses. They use too little or too much therapy. They may take medications too soon or too far apart. While adherence to injection treatments tend to be better than adherence to topical or oral treatment, adherence to injections may still be poor.

Traditional methods for measuring medical adherence-including questionnaires, surveys, and diaries- tend to be unreliable overestimate adherence. Chemical markers are problematic because of the tendency for patients to use their medication right before visits, so called "white coat compliance." Our research team has pioneered the use of electronic monitoring devices which measure and record the date and time of medication events to assess adherence in dermatology. The study team have demonstrated the feasibility of using such monitors to measure adherence to adalimumab in patients with psoriasis. Although only a small study, it documented a broad range of how patients use adalimumab and found that adherence was poor in about half of the patients. While the impact of psoriasis on patients' lives is large, adherence is still poor. How adherent patients with hidradenitis are to weekly adalimumab treatment is not yet well characterized.

Study Overview

• Status: Withdrawn
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Adalimumab; Other: Electronic Reporting

Detailed Description

This is a prospective single-center open-label randomized 6 month study. There will not be a washout period. Treatment will be for 26 weeks.

Subjects will have baseline disease severity assessments. Subjects will be instructed to take adalimumab according to the labelled dosing regimen. Subjects will be randomized to either standard-of-care or to an electronic reporting intervention.

The reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter.

Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.

Primary Endpoints: Adherence to adalimumab treatment

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest Health Sciences Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects ages 18 - 70
• Diagnosis of HS for which adalimumab is indicated according to the adalimumab prescribing information.
• All subjects must have a negative TB skin test according to prescribing guidelines.
• Subjects must be starting adalimumab for the first time, prescribed by their dermatologist.

Exclusion Criteria:

• All experimental drugs or devices are to be discontinued at least 1 month prior to initiation of study therapy.
• Subjects who are receiving biologic therapy with a potential therapeutic impact on hidradenitis within 3 months will be excluded.
• Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
• Subjects who have received live vaccines within a 3 month period prior to enrollment will also be excluded.
• In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard-of-Care; Subjects will be instructed to take adalimumab according to the labeled dosing regimen. Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.	Drug: Adalimumab; Subjects will be instructed to take Humira according to the labelled dosing regimen. Treatment will be for 26 weeks; Other Names: Humira
Experimental: Electronic Reporting; Subjects will be instructed to take adalimumab according to the labeled dosing regimen. The electronic reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter. Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.	Drug: Adalimumab; Subjects will be instructed to take Humira according to the labelled dosing regimen. Treatment will be for 26 weeks; Other Names: Humira; Other: Electronic Reporting; The electronic reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter. Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days between each dose for all subjects	assessment of adalimumab treatment	week 12 post randomization
Number of days between each dose for all subjects	assessment of adalimumab treatment	week 26 post randomization
Percentage of patients who achieve adherence success	percentage who have taken over 90% of correct doses of study drug	week 12 post randomization
Percentage of patients who achieve adherence success	percentage who have taken over 90% of correct doses of study drug	week 26 post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Doses Taken	Measured by MEMs cap	week 12 post randomization
Number of Doses Taken	Measured by MEMs cap	week 26 post randomization
Physician Global Assessment (PGA)	Assessment score ranges from 0 to 5 with a higher score denoting a worse outcome.	week 12 post randomization
Physician Global Assessment (PGA)	Assessment score ranges from 0 to 5 with a higher score denoting a worse outcome.	week 26 post randomization
Hidradentis Suppurativa Clinical Response (HiSCR)	Hidradenitis Suppurativa Clinical Response (HiSCR) measures number of inflammatory lesions.	week 12 post randomization
Hidradentis Suppurativa Clinical Response (HiSCR)	Hidradenitis Suppurativa Clinical Response (HiSCR) measures number of inflammatory lesions.	week 26 post randomization
Dermatology Life Quality Index (DLQI)	Scale ranges from 0 to 30 with a higher rating denoting a worse outcome.	week 12 post randomization
Dermatology Life Quality Index (DLQI)	Scale ranges from 0 to 30 with a higher rating denoting a worse outcome.	week 26 post randomization
Number of Doses Missed		week 26 post randomization
Total Time in Study		week 26 post randomization

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Rita O Pichardo, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2020
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: adalimumab; medical adherence
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: IRB00050544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes