1. PO1177 – Psoriasis and obstructive sleep apnea
Robert Bissonnette MD, FRCPC, Chantal Bolduc, MD, FRCPC, Simon Nigen, MD, FRCPC, Catherine Maari, MD, FRCPC.
Innovaderm Research Inc., Montreal, QC, Canada
Introduction
Obstructive sleep apnea (OSA) is a common disorder affecting up to
4% of the North American population (1). The prevalence is
increased in middle age and obese individuals. The exact
prevalence in patients with psoriasis is unknown but preliminary data
suggests that it may be increased (2).
Untreated sleep apnea leads to chronic fatigue and daytime
sleepiness which can interfere with the ability to work and perform
daily activities. In addition, OSA increases blood pressure and has
been associated with an increased risk of stroke, myocardial
infarction and mortality (3).
OSA has been linked to high tissue levels of tumor necrosis factor-α
(TNF-α) and TNF receptor 1 and 2 (p55 and p75), suggesting that
inflammation plays a role in OSA (4-6). Interestingly, improvement in
non-psoriatic patients suffering from OSA has been reported
following treatment with etanercept in a small non randomized
controlled trial (7).
The objective of this ongoing trial is to study the efficacy and safety
of adalimumab in patients with psoriasis and OSA. Baseline data are
presented to demonstrate the prevalence of OSA in obese psoriasis
patients.
OSA
severity
Number of
apneas +
hypopneas /h
None <5
Mild ≥5 to <15
Moderate ≥15 to <30
Severe ≥30
Table 1. Definition of OSA severity (8).

2. PO1177 – Psoriasis and obstructive sleep apnea
Robert Bissonnette MD, FRCPC, Chantal Bolduc, MD, FRCPC, Simon Nigen, MD, FRCPC, Catherine Maari, MD, FRCPC.
Innovaderm Research Inc., Montreal, QC, Canada
Randomization Design
– Patients were randomized (1:1) at Day 0 to either
adalimumab or placebo ;
– Patients randomized to adalimumab received 80 mg
adalimumab at Day 0, 40 mg adalimumab at Week 1
and every other week until Week 7.
Polysomnography Procedure
– Ascertain eligibility of patients in a study comparing adalimumab
to placebo using polysomnography with moderate or severe
OSA.
– Determine the severity of OSA in patients with psoriasis as
measured by factors such as:
– Day -2:
• Overnight Polysomnography;
• Measurement with 24-lead polysomnograph.
• Number of apneas + hypopneas per hour;
• Sleep latency;
• Sleep efficiency;
• Total wake time;
• ESS;
• Desaturation Index;
• Minimum O2 Saturation;
• Rapid eye movement (REM) Latency;
• Functional Outcome of Sleep Questionnaire - FOSQ
(Range 5 to 25);
• Rapid Eye Movement (REM) duration;
• Non Rapid Eye Movement duration (NREM)
– Day -1:
• Multiple sleep latency tests (MSLT);
• Measurement of daytime sleep latency with 24-lead
polysomnograph during 5 successive 15-minute nap
periods at 2 hour intervals;
Study Population
– 20 patients, 18 to 80 years of age;
– Diagnosis of obstructive sleep apnea confirmed by at
least 15 episodes / hour of apnea / hypopnea at the
polysomnographic testing on Day -2.
– Moderate to severe chronic plaque type psoriasis
covering a minimum of 5% of the body surface area
(BSA).
Baseline Analysis
– Classification of screened patients by OSA severity.
– Distribution of apnea + hypopnea / hour scores of
screened patients.
– Presentation of polysomnographic data for randomized
patients.

3. PO1177 – Psoriasis and obstructive sleep apnea
Robert Bissonnette MD, FRCPC, Chantal Bolduc, MD, FRCPC, Simon Nigen, MD, FRCPC, Catherine Maari, MD, FRCPC.
Innovaderm Research Inc., Montreal, QC, Canada
Results
– The number of apnea + hypopneas per hour
of screened patients range was 1.5 – 112.3;
– Table 2 illustrates the distribution of the
screened psoriasis patients evaluated by
polysomnography by OSA severity;
– Baseline demographics and dermatological
data are of randomized patients presented in
Table 3;
Figure 1. Distribution of apnea + hypopnea scores of screened patients.
OSA severity
Number of
patients
None 1
Mild 1
Moderate 2
Severe 18
Table 2. Classification of screened
patients by OSA severity.
Baseline
criteria
Mean ± SD
Age 52.4 ± 12.0
Caucasian 20 (100%)
Sex (M) 18 (90%)
BMI 43.9 ± 8.8 kg/m2
BSA 11.2 ± 8.4
PGA 3.4 ± 0.5
PASI 11.0 ± 5.4
Table 3. Baseline demographic,
and dermatological data of
randomized patients (n = 20)

4. PO1177 – Psoriasis and obstructive sleep apnea
Robert Bissonnette MD, FRCPC, Chantal Bolduc, MD, FRCPC, Simon Nigen, MD, FRCPC, Catherine Maari, MD, FRCPC.
Innovaderm Research Inc., Montreal, QC, Canada
Baseline criteria Mean ± SD Normal
Apneas + hypopneas per hour 73.0 ± 29.1 ≤5*
Sleep latency (min) 15.6 ± 10.0 15-30*
Sleep efficiency 39.2 ± 21.7% 85%*
Total wake time (min) 119.1 ± 78.0 <30*
REM latency time (min) 209.6 ± 104.3 90-120*
Minimum oxygen saturation index 71.5 ± 13.7% ≥ 4%*
Daytime sleep latency (min) 6.0 ± 3.6 > 10 * ₸
ESS (out of 24) 14.6 ± 5.1 0-9*
FOSQ (out of 25) 15.4 ± 3.5 89.6 ± 8.6 (9) **
Table 4. Baseline OSA data of randomized patients (n = 20)
₸ MSLT score.
** Score for normal subjects was out of 100 (9).
* Normal ranges obtained from
sleep facility (Biron Laboratories,
Montreal, Canada)
Definitions
The Epworth Sleepiness Scale ESS is a self-administered questionnaire that gauges
daytime sleepiness. Patients are asked to rate their chances of snoozing during eight
specific daily activities. It is suggested that patients with scores of 10 or more out of
24 should see their doctor (10). Patients chose the most appropriate number for each
question in Table 5:
0 = would never doze or sleep.
1 = slight chance of dozing or sleeping
2 = moderate chance of dozing or sleeping
3 = high chance of dozing or sleeping
Situation
Sitting and reading
Watching TV
Sitting inactive in a public place
Being a passenger in a motor vehicle for
an hour or more
Lying down in the afternoon
Sitting and talking to someone
Sitting quietly after lunch (no alcohol)
Stopped for a few minutes in traffic
while driving
Results (cont)
– Number of apnea +
hypopneas per hour and
other OSA baseline
criteria for the 20
randomized patients are
presented in Table 4;
Table 5. Epworth Sleepiness Questions (10)

5. PO1177 – Psoriasis and obstructive sleep apnea
Robert Bissonnette MD, FRCPC, Chantal Bolduc, MD, FRCPC, Simon Nigen, MD, FRCPC, Catherine Maari, MD, FRCPC.
Innovaderm Research Inc., Montreal, QC, Canada
Discussion
A total of 81.8% of patients (18 of 22) screened for this study had
severe sleep apnea. In a study comparing severely obese men and
women with a diagnosis of OSA, and a BMI similar as those
screened for this study, the mean number of apnea/hypoapnea per
hour was 53.7 ± 22.9 and 41.6 ± 29.2 respectively (11). The mean
number of apnea/hypoapnea per hour for randomized patients in the
current study was 73 which is considered very high.
Conclusion
– Obstructive sleep apnea appears to be under diagnosed in
patients with psoriasis.
– Dermatologists should question their patients more often about
sleep problems, especially those who suffer from obesity.
– Patients with suspected sleep apnea should be referred for
polysomnographic evaluation.
Conflicts of interest
– This study for was funded by a grant from Abbott Laboratories.
References
1. Epstein LJ, et al. J Clin Sleep Med
2009;5:283-276.
2. Gowda S, et al. J Am Acad Dermatol.
2010; 63(1):114-123.
3. Shirasaki O. Hypertens Res. 2011 May
26. [E-Pub].
4. Bonifati C, et al. Clin Exp Dermatol.
1994;19-383-7.
5. Ettehadi P, et al. Clin Exp Immunol.
1994;96:146-51.
6. Vgontzas AN, et al. J Clin Endocrinol
Metabol. 1997;82:1313-6.
7. Vgontzas AN, et al. J Clin Endocrinol
Metabol. 2004;89:4409-13.
8. Nishibayashi M, et al. J Clin Sleep Med.
2008;4:242-7.
9. Weaver T. Sleep. 1997;20:835-43..
10. Johns MW, Sleep. 1991; 14:540-5.
11. Resta O, et al. Resp Med. 2005;99:91-6.

6. PO1177 – Psoriasis and obstructive sleep apnea
Robert Bissonnette MD, FRCPC, Chantal Bolduc, MD, FRCPC, Simon Nigen, MD, FRCPC, Catherine Maari, MD, FRCPC.
Innovaderm Research Inc., Montreal, QC, Canada
Discussion
A total of 81.8% of patients (18 of 22) screened for this study had
severe sleep apnea. In a study comparing severely obese men and
women with a diagnosis of OSA, and a BMI similar as those
screened for this study, the mean number of apnea/hypoapnea per
hour was 53.7 ± 22.9 and 41.6 ± 29.2 respectively (11). The mean
number of apnea/hypoapnea per hour for randomized patients in the
current study was 73 which is considered very high.
Conclusion
– Obstructive sleep apnea appears to be under diagnosed in
patients with psoriasis.
– Dermatologists should question their patients more often about
sleep problems, especially those who suffer from obesity.
– Patients with suspected sleep apnea should be referred for
polysomnographic evaluation.
Conflicts of interest
– This study for was funded by a grant from Abbott Laboratories.
References
1. Epstein LJ, et al. J Clin Sleep Med
2009;5:283-276.
2. Gowda S, et al. J Am Acad Dermatol.
2010; 63(1):114-123.
3. Shirasaki O. Hypertens Res. 2011 May
26. [E-Pub].
4. Bonifati C, et al. Clin Exp Dermatol.
1994;19-383-7.
5. Ettehadi P, et al. Clin Exp Immunol.
1994;96:146-51.
6. Vgontzas AN, et al. J Clin Endocrinol
Metabol. 1997;82:1313-6.
7. Vgontzas AN, et al. J Clin Endocrinol
Metabol. 2004;89:4409-13.
8. Nishibayashi M, et al. J Clin Sleep Med.
2008;4:242-7.
9. Weaver T. Sleep. 1997;20:835-43..
10. Johns MW, Sleep. 1991; 14:540-5.
11. Resta O, et al. Resp Med. 2005;99:91-6.