Open-label treatment with etanercept 50 mg/week subcutaneous injection

Etanercept

Sex: Female, Male

Race (NIH/OMB)

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

Dermatology Life Quality Index (DLQI)

PGA score on a 100 mm visual analog scale, with 0 mm corresponding to no active disease and 100 mm corresponding to very severe disease with multiple, painful inflammatory lesions.

Physician's Global Assessment Score (PGA)

numbers of lesions (nodules and abscesses) as assessed by a physician

No. of lesions

Patient self-report of pain on a 100-mm visual analog scale with 0 corresponding to no pain and 100 mm corresponding to severe pain

Patient Pain Score

Duration of time patient had hidradenitis suppurativa prior to trial (in years)

Duration of disease

Prior systemic and intralesional therapies

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.

50% Reduction in Number of Lesions (Percent of Participants)

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.

50% Reduction in Physician's Global Assessment Score (Percent of Participants)

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)

Patient Global Assessment

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.

Patient's Pain Score

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.

Dermatology Life Quality Index Score (DLQI)

Eligibility Assessment

12 Week Treatment Period

18-Week Post Treatment Assessment

Jennifer Goldfarb

Hidradenitis Suppurativa

etanercept 50 mg/week subcutaneous injection

hidradenitis/abdominal pain

Etanercept for Treatment of Hidradenitis

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