Trial Outcomes & Findings for Anakinra as a Treatment for Hydradenitis Suppurativa (NCT NCT01516749)

Results Overview

At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: \< 5 cm, 1 point; 5-10 cm, 3 points; \> 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points. Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Baseline, 8 weeks

Results posted on

2014-08-20

Participant Flow

Patients were recruited from an academic dermatology practice in San Francisco, CA; informed consent was obtained before study entry.

11 patients were screened for inclusion. 6 were eligible and were enrolled.

Participant milestones

Participant milestones
Measure	Anakinra All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Active Therapy STARTED	6
Active Therapy COMPLETED	5
Active Therapy NOT COMPLETED	1
Follow-up Off Therapy STARTED	5
Follow-up Off Therapy COMPLETED	4
Follow-up Off Therapy NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Anakinra All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Active Therapy Lost to Follow-up	1
Follow-up Off Therapy Lost to Follow-up	1

Baseline Characteristics

Anakinra as a Treatment for Hydradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anakinra n=6 Participants All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Age, Continuous	37 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Initial modified Sartorius score	78.5 units on a scale n=5 Participants
Initial C-reactive protein	30.6 mg/L STANDARD_DEVIATION 23.03 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Population: The 5 patients who completed 8 weeks of therapy

At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: \< 5 cm, 1 point; 5-10 cm, 3 points; \> 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points. Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.

Outcome measures

Outcome measures
Measure	Anakinra n=5 Participants All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Change in Modified Sartorius Score	-34.8 units on a scale Interval -62.05 to -7.56

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: Patients who completed 8 weeks of therapy

The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable). The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked "What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?" with a scale of 0=no acitivity to 100=maximal activity.

Outcome measures

Outcome measures
Measure	Anakinra n=5 Participants All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Change in Quality of Life Assessments Physician Global Assessment	-45.8 units on a scale Interval -69.5 to -22.1
Change in Quality of Life Assessments Patient Global Assessment	-35.6 units on a scale Interval -61.4 to -9.83

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: Patients who completed 8 weeks of therapy

Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life

Outcome measures

Outcome measures
Measure	Anakinra n=5 Participants All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Change in Dermatology Quality of Life Index (DLQI)	-8.4 units on a scale Interval -16.57 to -0.23

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: Patients who completed 8 weeks of therapy

Change assessed from baseline to end of treatment phase.

Outcome measures

Outcome measures
Measure	Anakinra n=5 Participants All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Change in C-reactive Protein	-16.7 mg/L Interval -36.14 to 2.784

Adverse Events

Anakinra

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anakinra n=6 participants at risk All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Skin and subcutaneous tissue disorders Painful injection site	100.0% 6/6 • 16 weeks: 8 weeks of study therapy, followed by an additional 8 weeks of follow-up off therapy Vital signs and physical examinations were undertaken at every visit. The investigators assessed adverse events throughout the study by direct patient query, observation by study personnel, and spontaneous patient reporting.

Additional Information

Kieron S. Leslie, MD

University of California, San Francisco

Phone: 415-206-4777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place