Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings
- Registration Number
- NCT00708708
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 926
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A etanercept (Enbrel®) Patients with moderate to severe plaque psoriasis
- Primary Outcome Measures
Name Time Method Duration of Drug-Free Interval Prior to Treatment Cycle 2 Cycle 1 Week 24 up to Cycle 2 Week 0 Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 5 Cycle 4 Week 24 up to Cycle 5 Week 0 Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 6 Cycle 5 Week 24 up to Cycle 6 Week 0 Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 3 Cycle 2 Week 24 up to Cycle 3 Week 0 Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 4 Cycle 3 Week 24 up to Cycle 4 Week 0 Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
- Secondary Outcome Measures
Name Time Method Psoriasis Area and Severity Index (PASI) Score Week 0, 12, 24 of Cycle 1 to 6 Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.
Percentage of Body Surface Area (BSA) Affected by Psoriasis Week 0, 12, 24 of Cycle 1 to 6 Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.
Static Physician Global Assessment (sPGA) of Disease Activity Week 0, 12, 24 of Cycle 1 to 6 Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.
Physician Global Assessment of Efficacy Week 24 of Cycle 1 to 6 Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Patient Global Assessment of Efficacy Week 24 of Cycle 1 to 6 Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Number of Injections Per Year Year 1, 2, 3, 4, 5 Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Cumulative Dose of Etanercept Per Year Year 1, 2, 3, 4, 5 Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Percentage of Time on Treatment in First Year Year 1 Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% \* (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.
Percentage of Time on Treatment Over Entire Period Cycle 1 up to Cycle 6 Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% \* (\[Date of last application - Date of first application + 1\] - Sum of duration of drug-free intervals \[days\])/(Date of last application - Date of first application + 1).
Patient's Global Assessment of Disease Activity (PatGA) Week 0, 12, 24 of Cycle 1 to 6 Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.
Dermatology Life Quality Index (DLQI) Score Week 0, 12, 24 of Cycle 1 to 6 DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) Week 0, 12, 24 of Cycle 1 to 6 EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.
Number of Participants With at Least 1 Concomitant Medication Cycle 1 Week 0 up to Cycle 6 Week 24 Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) Week 0, 12, 24 of Cycle 1 to 6 EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.
Annual Costs for Treatment With Etanercept Year 1, 2, 3, 4, 5 Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.
Average Cost of Treatment by Disease Severity Year 1, 2, 3, 4, 5 Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications Prior to study, Year 1, 2, 3, 4, 5 Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.
Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA) Week 0, 12, 24 of Cycle 1 to 6 Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.
Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score Week 0, 12, 24 of Cycle 1 to 6 Effect of drug free interval on DLQI was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO) Week 0, 12, 24 of Cycle 1 to 6 Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How long do you expect the drug-free interval to last for?" After the drug-free interval participants were asked, "How long did the drug-free interval last?" Results are reported for participant's perception of the length of drug-free interval.
Participant Perception of Drug-Free Interval: Reason for Returning to Practice Before Cycle 2, 3, 4, 5, 6 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "Why did you return to the practice today?" Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice.
Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "Do you basically like the idea of a drug-free interval?" After the drug-free interval participants were asked, "How did you like the current drug-free interval?" Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant's liking of the drug-free interval.
Participant Perception of Drug-Free Interval: Duration Before Cycle 2, 3, 4, 5, 6 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the length of the current drug-free interval?" Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant's perception of the duration of drug-free interval.
Participant Perception of Drug-Free Interval: Relapse of Symptoms Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How much are you concerned about a relapse of symptoms?" After the drug-free interval participants were asked, "Were you concerned about a relapse of symptoms during the drug-free interval?" Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant's perception of relapse of symptoms.
Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?" After the drug-free interval participants were asked, "To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?" Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant's perception of effective therapy after drug-free interval.
Participant Perception of Drug-Free Interval: Disease Activity Before Cycle 2, 3, 4, 5, 6 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the activity of your disease during the first half of the drug-free interval?" and "How would you assess the activity of your disease during the second half of the drug-free interval?" Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant's perception of disease activity during the first half and second half of drug-free interval.
Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition Before Cycle 2, 3, 4, 5, 6 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How much were you satisfied with the condition of your skin during the first half of the drug-free interval?" and "How much were you satisfied with the condition of your skin during the second half of the drug-free interval?" Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant's satisfaction with their skin condition during the first half and second half of drug-free interval.
Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval reduces the risk for adverse drug reactions." Results are reported for participant's perception of risk of adverse drug reactions.
Participant Perception of Drug-Free Interval: Reminder of Disease Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "During drug-free interval I will not be reminded permanently of my disease." Results are reported for participant's perception of reminder of disease during the drug-free interval.
Participant Perception of Drug-Free Interval: Comfort in Everyday Life Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval means more comfort in my everyday life." Results are reported for participant's perception of comfort of life during the drug-free interval.
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "If possible, would you prefer a continuous therapy without drug-free interval?" Participants responded as yes or no to the question. Results are reported for participant's preference towards continuous therapy.
Participant Perception of Drug-Free Interval: Recommendation of Therapy Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?" Participants responded as yes or no to the question. Results are reported for participant's likeliness to recommend therapy.
Criteria for Treatment Resumption Before Cycle 2, 3, 4, 5, 6 Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.
Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.
Trial Locations
- Locations (1)
Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm
🇩🇪Muenster, NRW, Germany