Trial Outcomes & Findings for Etanercept for Treatment of Hidradenitis (NCT NCT00107991)

NCT ID: NCT00107991

Last Updated: 2018-03-21

Results Overview

Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks. PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-03-21

Participant Flow

Participant milestones

Measure	Etanercept 50 mg/week subcutaneously
Eligibility Assessment STARTED	38
Eligibility Assessment COMPLETED	15
Eligibility Assessment NOT COMPLETED	23
12 Week Treatment Period STARTED	15
12 Week Treatment Period COMPLETED	10
12 Week Treatment Period NOT COMPLETED	5
18-Week Post Treatment Assessment STARTED	10
18-Week Post Treatment Assessment COMPLETED	8
18-Week Post Treatment Assessment NOT COMPLETED	2

Reasons for withdrawal

Measure	Etanercept 50 mg/week subcutaneously
Eligibility Assessment Disease not severe enough	7
Eligibility Assessment Unwilling to participate	7
Eligibility Assessment Positive purified protein derivative	4
Eligibility Assessment Abnormal labs	2
Eligibility Assessment Ongoing treatment with antibiotics	1
Eligibility Assessment chronic uncontrolled asthma	1
Eligibility Assessment hx of alcohol abuse in past 12 months	1
12 Week Treatment Period Lack of Efficacy	2
12 Week Treatment Period Adverse Event	1
12 Week Treatment Period Protocol Violation	1
12 Week Treatment Period Incarcerated	1
18-Week Post Treatment Assessment Adverse Event	2

Baseline Characteristics

Etanercept for Treatment of Hidradenitis

Baseline characteristics by cohort

Measure	Etanercept n=15 Participants 50 mg/week subcutaneously
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Dermatology Life Quality Index (DLQI)	19 units on a scale n=5 Participants
Physician's Global Assessment Score (PGA)	4.35 units on a scale n=5 Participants
No. of lesions	14 lesions n=5 Participants
Patient Pain Score	6.4 units on a scale n=5 Participants
Duration of disease	12 years n=5 Participants
Prior systemic and intralesional therapies Oral antibiotics	14 participants n=5 Participants
Prior systemic and intralesional therapies Accutane	9 participants n=5 Participants
Prior systemic and intralesional therapies Surgery	8 participants n=5 Participants
Prior systemic and intralesional therapies Intralesional corticosteroids	3 participants n=5 Participants
Prior systemic and intralesional therapies Oral contraceptives	2 participants n=5 Participants
Prior systemic and intralesional therapies Oral corticosteroids	1 participants n=5 Participants
Prior systemic and intralesional therapies Injected antibiotics	1 participants n=5 Participants
Prior systemic and intralesional therapies Ketoconazole	1 participants n=5 Participants
Prior systemic and intralesional therapies Nicomide	1 participants n=5 Participants
Prior systemic and intralesional therapies Spironolactone	1 participants n=5 Participants
Prior systemic and intralesional therapies Cimetidine	1 participants n=5 Participants
BMI	35.1 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.

PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.

Outcome measures

Measure	Etanercept n=15 Participants 50 mg/week subcutaneously
50% Reduction in Physician's Global Assessment Score (Percent of Participants)	20 percentage of participants Interval 4.3 to 48.1

SECONDARY outcome

Timeframe: 12 weeks

A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.

Outcome measures

Measure	Etanercept n=15 Participants 50 mg/week subcutaneously
50% Reduction in Number of Lesions (Percent of Participants)	13.3 percentage of participants Interval 1.66 to 40.5

SECONDARY outcome

Timeframe: 12 weeks

The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:

Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)

Outcome measures

Measure	Etanercept n=15 Participants 50 mg/week subcutaneously
Patient Global Assessment Much worse	0 participants
Patient Global Assessment Moderately worse (~50% more disease activity)	3 participants
Patient Global Assessment A little worse	1 participants
Patient Global Assessment Same	2 participants
Patient Global Assessment A little improved	4 participants
Patient Global Assessment Moderately improved (~50% reduction in disease)	4 participants
Patient Global Assessment Much better (almost no active disease)	0 participants

SECONDARY outcome

Timeframe: 12 weeks

Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Response rate was calculated as the percentage of patients classified as responders.

Outcome measures

Measure	Etanercept n=15 Participants 50 mg/week subcutaneously
Patient's Pain Score	26.7 Response Rate - % of participants Interval 7.8 to 55.1

SECONDARY outcome

Timeframe: 12 weeks

The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.

Response rates were calculated as the percentage of participants achieving a response.

Outcome measures

Measure	Etanercept n=15 Participants 50 mg/week subcutaneously
Dermatology Life Quality Index Score (DLQI)	20 Response Rate - % of participants Interval 4.3 to 48.1

Adverse Events

Etanercept

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Etanercept n=15 participants at risk 50 mg/week subcutaneously
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	26.7% 4/15
Skin and subcutaneous tissue disorders Injection site erythema, bruising, or irritation	13.3% 2/15
Gastrointestinal disorders Nausea	20.0% 3/15
Nervous system disorders Paresthesias	13.3% 2/15
Skin and subcutaneous tissue disorders Cellulitis	13.3% 2/15
Respiratory, thoracic and mediastinal disorders Chest pain	6.7% 1/15
Infections and infestations Flu-like symptoms	6.7% 1/15
Musculoskeletal and connective tissue disorders Muscle cramps	6.7% 1/15
Vascular disorders Hypertension	6.7% 1/15
Metabolism and nutrition disorders Elevated cholesterol	6.7% 1/15

Additional Information

Jennifer Goldfarb

UPenn

Phone: 215-662-2540

Email: jennifer.goldfarb@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place