This study will evaluate the effect and safety of adalimumab in approximately 20 subjects with mild to moderate psoriasis and sleep apnea and will be conducted in one treatment center located in Montreal. Patients with psoriasis often have additional disorders such as obesity. Obese patients are more at risk of developing obstructive sleep apnea. This is believed to be caused by both the collapse of upper airways and inflammation (swelling). Adalimumab, a drug currently approved by Health Canada for the treatment of psoriasis, blocks tumor necrosis factor-alpha (TNF-alpha). This chemical is present at higher levels in patients with sleep apnea. It is believed that adalimumab could improve obstructive sleep apnea by lowering the levels of TNF-alpha.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Patients receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.
Patients will receive 2 injections of placebo at week 0, one injection at week 1 and one injection every other week (EOW) thereafter.
Innovaderm Research Inc.
Montreal, Quebec, Canada
Number of sleep apnea per hour.
Changes from baseline in number of apnea/hypopnea per hour for patients with psoriasis randomized to adalimumab as compared to patients randomized to topical therapy.
Time frame: 56 Days
Sleep maintenance efficiency
Changes from baseline in sleep maintenance efficiency for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Total wake time
Changes from baseline in total wake time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo
Time frame: 56 days
Percentage of sleep time
Changes from baseline in percentage of sleep time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Time spent in REM (rapid eye movement) stage.
Changes from baseline in time spent in REM (rapid eye movement) stage for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Time spent in sleep stage N1
Changes from baseline in time spent in sleep stages N1 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Time spent in sleep stage N3
Changes from baseline in time spent in sleep stage N3 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
REM (rapid eye movement) latency time
Changes from baseline in REM (rapid eye movement) latency time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Minimum overnight oxygen saturation index
Changes from baseline in minimum overnight oxygen saturation index for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Oxygen desaturation index
Changes from baseline in oxygen desaturation index for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Sleep related quality of life questionnaire (FOSQ)
Changes from baseline in the sleep related quality of life questionnaire (FOSQ - functional outcome of sleep questionnaire) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Epworth sleepiness scale
Changes from baseline in patient's perception of daytime sleepiness as measured by the Epworth sleepiness scale for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Daytime sleep latency
Changes from baseline in daytime sleep latency time for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo
Time frame: 56 days
Safety of adalimumab
Evaluate the safety of adalimumab in patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 weeks
Body surface area (BSA)
Tertiary - Changes from baseline in Body Surface Area (BSA) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Physician's Global Assessment (PGA)
Tertiary - Changes from baseline in Physician's Global Assessment (PGA) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Psoriatic Area and Severity Index (PASI)
Tertiary - Changes from baseline in Psoriatic Area and Severity Index (PASI) for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
PASI 75 (75% reduction in Psoriatic Area and Severity Index)
Tertiary - Proportion of patients who achieve PASI 75 (75% reduction in Psoriatic Area and Severity Index) at Day 56 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Proportion with PGA (Physician's Global Assessment) of 0 or 1
Tertiary - Proportion of patients who achieve a PGA (Physician's Global Assessment) of 0 or 1 at Day 56 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
Time to sleep induction
Changes from baseline in time to sleep induction for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo
Time frame: 56 days
Time spent in sleep stages N2
Changes from baseline in time spent in sleep stages N2 for patients with psoriasis randomized to adalimumab as compared to patients randomized to placebo.
Time frame: 56 days
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