Trial Outcomes & Findings for PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept (NCT NCT00527072)

Last Updated: 2012-09-03

Results Overview

Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

217 participants

Primary outcome timeframe

Week 10

Results posted on

2012-09-03

Participant Flow

A total of 217 subjects enrolled into the study but 2 subjects did not receive any study medication so they were excluded from analysis.

Participant milestones

Participant milestones
Measure	Infliximab Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Overall Study STARTED	215
Overall Study COMPLETED	179
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Overall Study Adverse Event	13
Overall Study Lack of Efficacy	11
Overall Study Lost to Follow-up	3
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	7

Baseline Characteristics

PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab n=215 Participants Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	198 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age Continuous	44.4 years STANDARD_DEVIATION 13.32 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 10

Population: This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1.

Outcome measures

Outcome measures
Measure	Infliximab n=211 Participants Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0)	138 participants Interval 58.6 to 71.8

SECONDARY outcome

Timeframe: Week 10

Population: Analysis is based on observed mITT (modified Intent to Treat) patients. Treatment failures are classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, will not have data imputed at that visit.

A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.

Outcome measures

Outcome measures
Measure	Infliximab n=211 Participants Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10	167 participants Interval 73.0 to 84.4

SECONDARY outcome

Timeframe: Week 26

Population: This analysis is based on all observed mITT patients. The treatment failures will be classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, their data at that visit will not be imputed.

Outcome measures

Outcome measures
Measure	Infliximab n=209 Participants Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26	135 participants Interval 57.7 to 71.1

Adverse Events

Infliximab

Serious events: 8 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab n=215 participants at risk Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Cardiac disorders Myocardial ischaemia	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Gastrointestinal disorders Gastritis	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Infections and infestations Bursitis infective	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Infections and infestations Cellulitis	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Nervous system disorders Convulsion	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Nervous system disorders Paraesthesia	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.47% 1/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.

Other adverse events

Other adverse events
Measure	Infliximab n=215 participants at risk Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Infections and infestations Upper respiratory tract infection	9.8% 21/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Infections and infestations Nasopharyngitis	5.6% 12/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Musculoskeletal and connective tissue disorders Arthralgia	8.8% 19/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Nervous system disorders Headache	6.5% 14/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 11/215 • Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.

Additional Information

Sr. Director, Clinical Research - Medical Affairs

Janssen Biotech, Inc.

Phone: 215-325-5711

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60