Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Biological: Adalimumab

• Registration Number: NCT01265823
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

W11-050 is a Mexican open label multicenter study that has been designed to further assess the safety and efficacy of adalimumab in the treatment of patients with active plaque psoriasis who have failed prior conventional systemic psoriasis treatment or who are candidates for systemic therapy.

Detailed Description

Up to 150 subjects having a diagnosis of active plaque psoriasis and fulfilling the study eligibility criteria were enrolled in Mexico. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at week 1 until week 15). The study drug was self administered via subcutaneous (sc) injection. Safety and efficacy measures were performed throughout the study.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-02
• Results First Submitted: 2013-02-01
• Results First Submitted QC: 2013-02-01
• Last Update Submitted: 2013-02-01
• Results First Posted: 2013-03-11
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Able and willing to give written informed consent prior to any study related procedures and to comply with the requirements of the study protocol
2. Male and female subjects between 18 and 75 years old
3. Diagnosis of moderate to severe types I and II plaque psoriasis (Type I : symptoms onset before 40 years old; Type II: symptoms onset after 40 years old), with at least 6 months of duration
4. Documented moderate to severe plaque psoriasis based on Psoriasis Area and Severity Index (PASI) score >10
5. Subjects naïve to adalimumab therapy
6. Subject must be evaluated for active and latent tuberculosis (TB) infection by using a Purified Protein Derivative (PPD) skin test, chest x-ray (posterior to anterior (PA) and lateral views) and a detailed review of the subject's medical history. This screening must be negative
7. A negative pregnancy test (serum human chorionic gonadotrophin) for women of childbearing potential prior to start of study treatment. (Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy])
8. Able and willing to self-administer subcutaneous injections or have available a suitable person to administer subcutaneous injections
9. Subject is judged to be in generally good health as determined by the investigator

Exclusion Criteria

1. Prior treatment with any investigational agent within 30 days, or five half-lives of the product, which ever is longer. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to study entry (Baseline Visit)
2. Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with the evaluation of psoriasis or compromise the subject's safety
3. Subject has a history of dysplasia, malignancy (including lymphoma and leukemia), or lymphoproliferative disease other than: a. Successfully and completely treated non-metastatic squamous or basal cell carcinoma of the skin with no recurrence within the last five years. b. Localized carcinoma in situ of the cervix or cervical dysplasia, with no recurrence within the last five years
4. Persistent or recurrent infections or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days, or oral antibiotics, oral antivirals or oral antifungals within 14 days prior to Baseline Visit
5. Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure New York Heart Association (NYHA) III-IV, recent stroke (within three months), chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which, in the opinion of the investigator, may place the subject at risk
6. Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g., optic neuritis, ataxia, apraxia)
7. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB
8. Female subjects who are pregnant or breast-feeding
9. History of clinically significant drug or alcohol abuse in the last year
10. Subject started receiving a new topical therapy within the last four weeks prior to the Baseline visit for areas other than the palms, soles of feet, axilla and groin
11. Subject started being treated with ultraviolet B (UVB) phototherapy, within the last four weeks prior to the Baseline visit
12. Subject was treated with psoralen ultraviolet A (PUVA) phototherapy within the last four weeks prior to the Baseline visit
13. Subject has been initiated on a new systemic agent within the last four weeks prior to the Baseline visit
14. Patients with history of atopy
15. Patients with any other autoimmune disease such as systemic lupus erythematosus (SLE) , Sdx Sjögren, vasculitis etc
16. Known hypersensitivity to the excipients of adalimumab as stated in the label
17. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
18. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
19. Subject with any prior exposure to Tysabri (natalizumab), or Orencia (abatacept)
20. Subjects with positive immunologic test for hepatitis A, B or C (Positive test of any of the following: hepatitis A viral antibody immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab)
21. Subjects with a positive immunologic test for HIV determined by enzyme-linked immunosorbent assay (ELISA) method

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab	Adalimumab	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4	Week 4	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16	Week 16	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4	Week 4	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score \<6 indicates that psoriasis has small or no effect at all on participant's life.
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16	Week 16	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score \<6 indicates that psoriasis has small or no effect at all on participant's life.

Secondary Outcome Measures

Name	Time	Method
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4	Baseline, Week 4	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16	Baseline, Week 16	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Dermatology Life Quality Index (DLQI) Categories at Week 4	Week 4	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.
Serum Levels of Folic Acid at Baseline and Week 16	Baseline, Week 16	Normal values for folic acid were 3-15 ng/mL.
Dermatology Life Quality Index (DLQI) Categories at Week 16	Week 16	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4	Week 4	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16	Week 16	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.
Physician's Global Assessment (PGA) at Week 4	Week 4	The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).
Physician's Global Assessment (PGA) at Week 16	Week 16	The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present). The number of participants who achieve a PGA of 'clear' or 'almost clear' at Week 16 was a secondary outcome measure in this study.
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16	Baseline, Week 16	Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.
Mean Homocysteine Levels at Baseline and Week 16	Baseline, Week 16	Normal values for homocysteine were 5-13.9 µmol/L.
Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16	Week 16	The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of \<6 (see Outcome Measure 3 for details).
Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16	Week 16	The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of \>1 for men and \>0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of \<6 (see Outcome Measure 3 for details).
Serum Levels of Folic Acid at Baseline and Week 4	Baseline, Week 4	Normal values for folic acid were 3-15 ng/mL.
Serum Levels of Vitamin B6 at Baseline and Week 4	Baseline, Week 4	Normal values for vitamin B6 were 18-175 nmol/L.
Serum Levels of Vitamin B12 at Baseline and Week 4	Baseline, Week 4	Normal values for vitamin B12 were 200-1100 pg/mL.
Serum Levels of Vitamin B6 at Baseline and Week 16	Baseline, Week 16	Normal values for vitamin B6 were 18-175 nmol/L.
Serum Levels of Vitamin B12 at Baseline and Week 16	Baseline, Week 16	Normal values for vitamin B12 were 200-1100 pg/mL.

Trial Locations

Locations (8)

Site Reference ID/Investigator# 41062; 🇲🇽 Toluca de Lerdo, Mexico

Site Reference ID/Investigator# 40662; 🇲🇽 Toluca de Lerdo, Mexico

Site Reference ID/Investigator# 40963; 🇲🇽 Zapopan, Mexico

Site Reference ID/Investigator# 50942; 🇲🇽 Circuito Comercial Satelite, Mexico

Site Reference ID/Investigator# 40962; 🇲🇽 Monterrey, Mexico

Site Reference ID/Investigator# 40964; 🇲🇽 Iztapalapa, Mexico

Site Reference ID/Investigator# 40965; 🇲🇽 Monterrey, Mexico

Site Reference ID/Investigator# 50943; 🇲🇽 Mexico City, Mexico