Trial Outcomes & Findings for A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis (NCT NCT00513370)

NCT ID: NCT00513370

Last Updated: 2011-04-11

Results Overview

PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 203 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2011-04-11

Participant Flow

Participant milestones

Measure	Adalimumab 40 mg Eow adalimumab 40 mg every other week (eow)
Overall Study STARTED	203
Overall Study COMPLETED	179
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis

Baseline characteristics by cohort

Measure	Adalimumab 40 mg Eow n=203 Participants adalimumab 40 mg every other week (eow)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	192 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age Continuous	45.5 years STANDARD_DEVIATION 12.34 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants
Region of Enrollment Canada	203 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=191 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks adalimumab 40 mg every other week - Week 24 timepoint
Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks Responder	144 participants	—
Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks Non-responder	47 participants	—

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Mean change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=191 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=183 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks Change from Baseline	-15.9 unit on a scale Standard Deviation 7.55	-16.1 unit on a scale Standard Deviation 7.46

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Mean percent change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=191 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=183 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks	-81.5 percent change Standard Deviation 23.63	-83.0 percent change Standard Deviation 23.47

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Number of subjects with improvement on the Physician's Global Assessment for Psoriasis (PGA). The PGA is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject, where 0 = clear and 6 = very severe. Improvement is defined as a reduction in PGA score.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=203 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=181 Participants adalimumab 40 mg every other week - Week 24 timepoint
Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)	174 participants	164 participants

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Number of subjects achieving a response of "Clear" or "Clear or Minimal" on the Physician's Global Assessment for Psoriasis. This is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Minimal, 2-Mild, 3-Moderate, 4-severe, 5-very severe.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=191 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=183 Participants adalimumab 40 mg every other week - Week 24 timepoint
Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of "Clear" or "Clear or Minimal" Subjects achieving "Clear"	53 participants	59 participants
Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of "Clear" or "Clear or Minimal" Subjects achieving "Clear or Minimal"	111 participants	121 participants

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Mean Change from Baseline in Physician Global Assessment of Arthritic Disease Activity as measured on a 100-mm visual analog scale where 0 mm = no arthritis activity and 100 mm = extremely active arthritis.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=91 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=85 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity at 16 and 24 Weeks	-18.7 units on a scale Standard Deviation 23.48	-20.9 units on a scale Standard Deviation 23.32

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

PASI 50/75/90/100 is a >=50% / >=75% / >=90% / 100% improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=191 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=183 Participants adalimumab 40 mg every other week - Week 24 timepoint
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response Subjects achieving PASI 50	169 participants	163 participants
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response Subjects achieving PASI 75	144 participants	140 participants
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response Subjects achieving PASI 90	100 participants	102 participants
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response Subjects achieving PASI 100	49 participants	58 participants

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Mean change in the number of tender joints from Baseline. 78 joints were evaluated for tenderness, including all 76 joints evaluated for swelling plus the hip joints.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=40 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=39 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Change From Baseline in Tender Joint Count at 16 and 24 Weeks	-8.7 number of joints Standard Deviation 13.57	-8.7 number of joints Standard Deviation 14.83

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Mean change in the number of swollen joints from Baseline. 76 joints were evaluated for swelling, corresponding to all joints evaluated for tenderness except for the hip joints.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=31 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=31 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Change From Baseline in Swollen Joint Count at 16 and 24 Weeks	-4.7 number of joints Standard Deviation 5.35	-4.9 number of joints Standard Deviation 7.08

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Mean change in the Patient's Global Assessment of Joint Pain from Baseline, as assessed on a 100-mm visual analog scale where 0 mm = no pain and 100 mm = pain as bad as it could be.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=137 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=129 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Change From Baseline in Patient's Global Assessment of Joint Pain at 16 and 24 Weeks	-20.9 units on a scale Standard Deviation 31.77	-19.3 units on a scale Standard Deviation 32.02

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Mean change in the Dermatology Life Quality Index (DLQI) from Baseline. The questionnaire contains 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired; the minimum clinically important difference is 2.3 to 5.7 point change.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=191 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=182 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at 16 and 24 Weeks	-9.8 units on a scale Standard Deviation 7.09	-10.1 units on a scale Standard Deviation 7.26

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Number of subjects achieving a Dermatology Life Quality Index (DLQI) score of 0 (indicating total lack of impairment). The DLQI consists of 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=191 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=182 Participants adalimumab 40 mg every other week - Week 24 timepoint
Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0	67 participants	83 participants

SECONDARY outcome

Timeframe: 16 and 24 weeks

Population: Observed Cases - subjects with nonmissing values at each time point

Change in the Beck Depression Inventory from Baseline. The BDI-II contains 21 questions and is scored from 0-63; higher scores indicate more severe depression symptoms.

Outcome measures

Measure	Adalimumab 40 mg Eow - 16 Weeks n=175 Participants adalimumab 40 mg every other week - Week 16 timepoint	Adalimumab 40 mg Eow - 24 Weeks n=173 Participants adalimumab 40 mg every other week - Week 24 timepoint
Mean Change From Baseline in Beck Depression Inventory (BDI-II) at 16 and 24 Weeks	-4.1 units on a scale Standard Deviation 6.56	-4.3 units on a scale Standard Deviation 6.71

SECONDARY outcome

Timeframe: 16 and 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 and 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 and 24 weeks

Outcome measures

Outcome data not reported

Adverse Events

Adalimumab 40 mg Eow

Serious events: 9 serious events

Other events: 145 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab 40 mg Eow adalimumab 40 mg every other week (eow)
Gastrointestinal disorders Tongue oedema	0.49% 1/203 • Number of events 1
Cardiac disorders Myocardial infarction	0.99% 2/203 • Number of events 2
Cardiac disorders Pericarditis	0.49% 1/203 • Number of events 1
General disorders Death	0.49% 1/203 • Number of events 1
Infections and infestations Appendicitis	0.49% 1/203 • Number of events 1
Infections and infestations Pneumonia	0.49% 1/203 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.49% 1/203 • Number of events 1
Renal and urinary disorders Renal vasculitis	0.49% 1/203 • Number of events 1
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.49% 1/203 • Number of events 1

Other adverse events

Measure	Adalimumab 40 mg Eow adalimumab 40 mg every other week (eow)
Gastrointestinal disorders Diarrhoea	3.0% 6/203 • Number of events 7
Gastrointestinal disorders Nausea	3.0% 6/203 • Number of events 6
General disorders Injection site reaction	3.4% 7/203 • Number of events 10
General disorders Fatigue	2.5% 5/203 • Number of events 5
General disorders Oedema peripheral	2.5% 5/203 • Number of events 5
General disorders Injection site erythema	2.0% 4/203 • Number of events 16
Infections and infestations Upper respiratory tract infection	10.8% 22/203 • Number of events 30
Infections and infestations Nasopharyngitis	10.8% 22/203 • Number of events 24
Infections and infestations Influenza	4.9% 10/203 • Number of events 12
Infections and infestations Bronchitis	3.0% 6/203 • Number of events 6
Infections and infestations Pharyngitis	2.5% 5/203 • Number of events 5
Infections and infestations Gastroenteritis	2.5% 5/203 • Number of events 5
Infections and infestations Pneumonia	2.0% 4/203 • Number of events 4
Infections and infestations Sinusitis	2.0% 4/203 • Number of events 5
Infections and infestations Pharyngitis streptococcal	2.0% 4/203 • Number of events 4
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 8/203 • Number of events 8
Musculoskeletal and connective tissue disorders Back pain	2.5% 5/203 • Number of events 5
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 4/203 • Number of events 5
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	2.0% 4/203 • Number of events 4
Nervous system disorders Headache	4.9% 10/203 • Number of events 16
Nervous system disorders Migraine	2.0% 4/203 • Number of events 4
Nervous system disorders Dizziness	2.0% 4/203 • Number of events 5
Respiratory, thoracic and mediastinal disorders Cough	2.5% 5/203 • Number of events 6
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.0% 4/203 • Number of events 4
Skin and subcutaneous tissue disorders Psoriasis	3.4% 7/203 • Number of events 7
Skin and subcutaneous tissue disorders Pruritus	3.0% 6/203 • Number of events 7
Vascular disorders Hypertension	3.4% 7/203 • Number of events 7

Additional Information

Medical Information Specialist

Abbott

Phone: 1-800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee The first publication and presentation of this Study shall reside with Abbott. No independent manuscript may be submitted for publication until the first manuscript has been accepted for publication or twelve (12) months after completion of Study at all sites, which ever occurs first.
• Publication restrictions are in place

Restriction type: OTHER