NCT02570750

The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

Completed Results posted Last updated 20 December 2018

What this trial tests

trial testing QUESTIONNAIRE ON SMOKING HABITS in Chronic Plaque Psoriasis in 183 participants. Completed in 5 December 2016.

Timeline

7 May 2015

Primary endpoint
5 December 2016

5 December 2016

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	183
Start date	7 May 2015
Primary completion	5 December 2016
Estimated completion	5 December 2016
Sites	30 locations across Romania

Drugs / interventions tested

• QUESTIONNAIRE ON SMOKING HABITS

Conditions studied

• Chronic Plaque Psoriasis — all drugs for Chronic Plaque Psoriasis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Chronic Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 Primary · Baseline, Week 24

PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point s

Baseline

Group	Value	95% CI
Etanercept: Non Smokers	23.1	± 6.2
Etanercept: Smokers	23.4	± 6.1

Change at Week 24

Group	Value	95% CI
Etanercept: Non Smokers	16.5	± 5.2
Etanercept: Smokers	17.1	± 5.4

Change From Baseline in Dermatology Life Quality Index (DLQI) Secondary · Baseline, Week 12, 24

The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher sco

Baseline

Group	Value	95% CI
Etanercept: Non Smokers	22.0	± 5.3
Etanercept: Smokers	21.7	± 4.8

Change at Week 12

Group	Value	95% CI
Etanercept: Non Smokers	12.3	± 6.0
Etanercept: Smokers	12.8	± 4.9

Change at Week 24

Group	Value	95% CI
Etanercept: Non Smokers	16.4	± 6.0
Etanercept: Smokers	16.8	± 4.6

Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 Secondary · Week 12, 24

PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point s

Week 12

Group	Value	95% CI
Etanercept: Non Smokers	9.3
Etanercept: Smokers	4.4

Week 24

Group	Value	95% CI
Etanercept: Non Smokers	45.8
Etanercept: Smokers	44.1

Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 Secondary · Week 12, 24

PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point s

Week 12

Group	Value	95% CI
Etanercept: Non Smokers	77.0
Etanercept: Smokers	82.3

Week 24

Group	Value	95% CI
Etanercept: Non Smokers	97.9
Etanercept: Smokers	98.5

Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 Secondary · Week 12

PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point s

Group	Value	95% CI
Etanercept: Non Smokers	12.6	± 4.4
Etanercept: Smokers	12.8	± 4.6

Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants Secondary · Baseline, Week 12, 24

PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point s

Baseline

Group	Value	95% CI
Etanercept: Non Smokers	24.2	± 6.12
Etanercept: Smokers	23.9	± 7.14

Change at Week 12

Group	Value	95% CI
Etanercept: Non Smokers	12.2	± 4.52
Etanercept: Smokers	12.1	± 5.21

Change at Week 24

Group	Value	95% CI
Etanercept: Non Smokers	17.1	± 5.79
Etanercept: Smokers	16.8	± 4.26

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Etanercept: Non Smokers

Serious: 2/96 (2%)

Deaths: 0/96

Etanercept: Smokers

Serious: 3/68 (4%)

Deaths: 1/68

Serious adverse events (5 terms)

Reaction	System	Etanercept: Non Smokers	Etanercept: Smokers
Inflammation at site injection	Infections and infestations	—	—
Diabetic gangrene	Endocrine disorders	—	—
Cerebellar haematoma	Nervous system disorders	—	—
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—	—
Erytrodermic psoriasis	Immune system disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Etanercept: Non Smokers	Etanercept: Smokers
Erytrodermic psoriasis	Skin and subcutaneous tissue disorders	—	—
Injection site erythema	General disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Pustular psoriasis	Skin and subcutaneous tissue disorders	—	—
Increase of serum transaminases	Investigations	—	—
Urinary tract infection	Infections and infestations	—	—

Most-reported serious reactions: Inflammation at site injection, Diabetic gangrene, Cerebellar haematoma, Acute respiratory distress syndrome, Erytrodermic psoriasis.

Data from ClinicalTrials.gov NCT02570750 adverse events section.

Sponsor's own description

The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.