N/A N=955

Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT00708708 ↗

Enrolled (actual)

955

Serious AEs

6.4%

Results posted

Jul 2015

Primary outcome: Primary: Duration of Drug-Free Interval Prior to Treatment Cycle 2 — 12.6 weeks

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: etanercept (Enbrel®) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Drug-Free Interval Prior to Treatment Cycle 2	12.6	—
PRIMARY Duration of Drug-Free Interval Prior to Treatment Cycle 3	10.5	—
PRIMARY Duration of Drug-Free Interval Prior to Treatment Cycle 4	25.0	—
PRIMARY Duration of Drug-Free Interval Prior to Treatment Cycle 5	20.6	—
PRIMARY Duration of Drug-Free Interval Prior to Treatment Cycle 6	14.2	—
SECONDARY Psoriasis Area and Severity Index (PASI) Score	21.0; 8.8; 5.9; 6.7; 4.9; 4.8	—
SECONDARY Percentage of Body Surface Area (BSA) Affected by Psoriasis	28.2; 36.7; 35.1; 14.0; 20.1; 21.6	—
SECONDARY Static Physician Global Assessment (sPGA) of Disease Activity	3.1; 1.9; 1.6; 1.7; 1.5; 1.5	—
SECONDARY Physician Global Assessment of Efficacy	304; 214; 68; 20; 242; 151	—
SECONDARY Patient Global Assessment of Efficacy	297; 216; 65; 27; 229; 165	—
SECONDARY Number of Injections Per Year	47.0; 30.8; 32.1; 15.6; 11.8	—
SECONDARY Cumulative Dose of Etanercept Per Year	2249.2; 1474.7; 1565.5; 729.1; 399.5	—
SECONDARY Percentage of Time on Treatment in First Year	96.5	—
SECONDARY Percentage of Time on Treatment Over Entire Period	94.8	—
SECONDARY Patient's Global Assessment of Disease Activity (PatGA)	3.7; 2.2; 1.9; 2.2; 1.7; 1.7	—
SECONDARY Dermatology Life Quality Index (DLQI) Score	14.0; 6.4; 4.9; 6.2; 4.3; 4.2	—
SECONDARY Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)	0.817; 0.915; 0.930; 0.915; 0.933; 0.939	—
SECONDARY Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)	73.8; 85.1; 87.7; 85.6; 88.6; 89.5	—
SECONDARY Number of Participants With at Least 1 Concomitant Medication	368	—
SECONDARY Annual Costs for Treatment With Etanercept	20670.0; 13509.6; 14113.4; 6847.4; 5173.7	—
SECONDARY Average Cost of Treatment by Disease Severity	20707.0; 21627.0; 21309.2; 13777.1; 9668.8; 5479.7	—
SECONDARY Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications	77.1; 194.8; 91.2; 128.8; 31.5; 53.6	—
SECONDARY Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)	3.7; 3.9; 2.1; 2.1; 1.9; 1.8	—
SECONDARY Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score	13.8; 15.5; 5.7; 7.1; 4.7; 4.7	—
SECONDARY Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)	0.810; 0.809; 0.914; 0.916; 0.921; 0.944	—
SECONDARY Participant Perception of Drug-Free Interval: Length of Drug-Free Interval	0.9; 2.4; 1.4; 1.6; 4.5; 1.8	—
SECONDARY Participant Perception of Drug-Free Interval: Reason for Returning to Practice	66; 46; 4; 16; 26; 1	—
SECONDARY Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval	2.6; 2.5; 3.1; 2.9; 2.1; 1.0	—
SECONDARY Participant Perception of Drug-Free Interval: Duration	2.5; 2.9; 1.0; 2.0; 2.0	—
SECONDARY Participant Perception of Drug-Free Interval: Relapse of Symptoms	4.4; 4.1; 4.1; 4.0; 4.9; 4.2	—
SECONDARY Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval	4.6; 4.4; 4.4; 4.3; 4.7; 5.0	—
SECONDARY Participant Perception of Drug-Free Interval: Disease Activity	2.4; 3.3; 2.3; 3.0; 2.5; 3.3	—
SECONDARY Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition	3.3; 2.7; 3.2; 2.8; 3.5; 2.3	—
SECONDARY Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions	3.0; 3.2; 2.9; 3.1; 2.3; 1.6	—
SECONDARY Participant Perception of Drug-Free Interval: Reminder of Disease	2.4; 2.5; 2.7; 2.7; 1.6; 1.6	—
SECONDARY Participant Perception of Drug-Free Interval: Comfort in Everyday Life	2.3; 2.6; 2.6; 2.6; 1.8; 1.8	—
SECONDARY Participant Perception of Drug-Free Interval: Preference to Continuous Therapy	9; 95; 8; 98; 8; 32	—
SECONDARY Participant Perception of Drug-Free Interval: Recommendation of Therapy	0; 106; 0; 107; 1; 39	—
SECONDARY Criteria for Treatment Resumption	90; 42; 8; 4; 0; 0	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)	273; 59	—

Summary

This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.

Eligibility Criteria

Inclusion Criteria

Subjects with moderate to severe plaque psoriasis on etanercept treatment according to the Summary of Product Characteristics (SmPC), and applicable local guidelines
Subjects for whom the decision has already been made to initiate treatment with etanercept

Exclusion Criteria

Sepsis or risk of sepsis
Current or recent infections, including chronic or localized, e.g. tuberculosis (TB) infection
Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study
Pre-existing or recent onset CNS demyelinating disease.
Class III or IV congestive heart failure as defined by the New York Heart Association classification or uncompensated congestive heart failure.
Previous or ongoing treatment with etanercept
Participation in other clinical or observational studies.
Patients with psoriatic arthritis requiring continuous etanercept treatment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00708708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.