Trial Outcomes & Findings for Infliximab in High Need Versus Low Need Psoriasis Patients: The IHELP Study (Study P04320)(COMPLETED) (NCT NCT00254982)
NCT ID: NCT00254982
Last Updated: 2015-10-12
Results Overview
PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
593 participants
Primary outcome timeframe
Baseline and Week 22
Results posted on
2015-10-12
Participant Flow
Participant milestones
| Measure |
Group 1 (High-need)
Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
Group II (Low-need)
Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
|---|---|---|
|
Overall Study
STARTED
|
297
|
296
|
|
Overall Study
COMPLETED
|
261
|
265
|
|
Overall Study
NOT COMPLETED
|
36
|
31
|
Reasons for withdrawal
| Measure |
Group 1 (High-need)
Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
Group II (Low-need)
Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
|---|---|---|
|
Overall Study
Other
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Adverse Event
|
18
|
16
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Inclusion/exclusion criteria violation
|
0
|
2
|
|
Overall Study
Protocol deviation
|
1
|
1
|
|
Overall Study
Diagnosis of Tuberculosis
|
1
|
1
|
|
Overall Study
Malignancy
|
0
|
2
|
|
Overall Study
Opportunistic infection
|
1
|
0
|
|
Overall Study
Abnormal liver function tests
|
2
|
1
|
Baseline Characteristics
Infliximab in High Need Versus Low Need Psoriasis Patients: The IHELP Study (Study P04320)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Group 1 (High-need)
n=297 Participants
Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
Group II (Low-need)
n=296 Participants
Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
Total
n=593 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 83 years
|
297 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
593 Participants
n=5 Participants
|
|
Age, Customized
>83 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
210 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
405 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 22Population: Per Protocol Population - All participants in the intent to treat population who completed the study without major protocol violations. For missing data, the last observation carried forward (LOCF) was applied.
PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
Outcome measures
| Measure |
Group 1 (High-need)
n=264 Participants
Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
Group II (Low-need)
n=265 Participants
Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
|
|---|---|---|
|
Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score
|
0.739 Proportion of participants
|
0.698 Proportion of participants
|
Adverse Events
Group 1 (High-need)
Serious events: 26 serious events
Other events: 62 other events
Deaths: 0 deaths
Group 2 (Low-need)
Serious events: 18 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (High-need)
n=297 participants at risk
|
Group 2 (Low-need)
n=296 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Ear and labyrinth disorders
SUDDEN HEARING LOSS
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Ear and labyrinth disorders
VERTIGO
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Eye disorders
BLINDNESS UNILATERAL
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Eye disorders
RETINAL DETACHMENT
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Eye disorders
VITREOUS DISORDER
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Gastrointestinal disorders
DUODENITIS
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.67%
2/297 • Number of events 2
|
0.00%
0/296
|
|
General disorders
ASTHENIA
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
General disorders
CHILLS
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
General disorders
INFUSION RELATED REACTION
|
1.0%
3/297 • Number of events 3
|
0.68%
2/296 • Number of events 2
|
|
General disorders
OEDEMA PERIPHERAL
|
0.67%
2/297 • Number of events 2
|
0.00%
0/296
|
|
General disorders
PYREXIA
|
0.34%
1/297 • Number of events 1
|
0.34%
1/296 • Number of events 1
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Immune system disorders
SERUM SICKNESS
|
0.67%
2/297 • Number of events 2
|
0.00%
0/296
|
|
Infections and infestations
PNEUMONIA
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Infections and infestations
SKIN INFECTION
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Infections and infestations
TONSILLITIS
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Infections and infestations
TUBERCULOSIS
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Injury, poisoning and procedural complications
STERNAL FRACTURE
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Injury, poisoning and procedural complications
WHIPLASH INJURY
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.34%
1/297 • Number of events 1
|
0.34%
1/296 • Number of events 1
|
|
Investigations
TRANSAMINASES INCREASED
|
1.0%
3/297 • Number of events 3
|
0.34%
1/296 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.34%
1/297 • Number of events 1
|
0.34%
1/296 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHANGIOSIS CARCINOMATOSA
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC RENAL CELL CARCINOMA
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Reproductive system and breast disorders
EPIDIDYMITIS
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.67%
2/297 • Number of events 2
|
0.00%
0/296
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
1.3%
4/297 • Number of events 4
|
0.34%
1/296 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Surgical and medical procedures
BURSA REMOVAL
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Surgical and medical procedures
URETHRAL OPERATION
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
0.34%
1/297 • Number of events 1
|
0.00%
0/296
|
|
Vascular disorders
SHOCK
|
0.00%
0/297
|
0.34%
1/296 • Number of events 1
|
Other adverse events
| Measure |
Group 1 (High-need)
n=297 participants at risk
|
Group 2 (Low-need)
n=296 participants at risk
|
|---|---|---|
|
General disorders
INFLUENZA LIKE ILLNESS
|
6.7%
20/297 • Number of events 22
|
6.1%
18/296 • Number of events 19
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.1%
30/297 • Number of events 35
|
5.4%
16/296 • Number of events 17
|
|
Nervous system disorders
HEADACHE
|
6.7%
20/297 • Number of events 25
|
4.1%
12/296 • Number of events 20
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to pubish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any elecontronic media) that report any results of study.
- Publication restrictions are in place
Restriction type: OTHER