Assessment of Long-Term Infliximab for Psoriasis (P05319) (REALITY)

Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis

This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Infliximab

Detailed Description

This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.

• Study Type: Observational
• Enrollment (Actual): 660

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with plaque-type psoriasis in which the treating physician has selected for treatment with infliximab, in accordance with local clinical practices, will be advised about this trial. It is highly recommended that 30% of the participants enrolled be naïve to previous biologic therapy. For example, if a site recruits 10 participants, 3 out of these 10 participants should be naïve to previous biologic therapy.

Description

Inclusion Criteria:

• Participant must have a diagnosis of plaque-type psoriasis
• Participant's physician must have decided, with the subject's consent, to start treatment with infliximab
• Participant must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent
• For inclusion into the extended treatment period, participant must have completed 50 weeks of infliximab treatment in the treatment period
• For inclusion into the extended treatment period, participant must be continuing treatment with intravenous infliximab
• For inclusion into the extended treatment period, participant must have an improvement in their PASI score of greater than or equal to 25% at the time of entry into to the extended treatment period

Exclusion Criteria:

For the Treatment Period

• Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is eligible for the trial (Inclusion Criteria). The treating physician is expected, as in normal clinical practice, to follow the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications and precautions

For the Extended Treatment Period

• Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is receiving infliximab treatment in accordance with the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications, precautions, dosing and frequency of administration

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Infliximab 5 mg/kg

Biological: Infliximab; Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).; Other Names: Remicade; SCH 215596

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50	Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.	Week 50

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14	Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline.	Week 50
Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14	Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline.	Week 50
Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14	Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline.	Week 50
Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period	Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline.	Week 98
Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period	Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively.	Week 98
Change From Baseline in Mean PASI Score	Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.	Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98
Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase	PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively.	Week 98
Change From Baseline in Mean Dermatology Life Quality Index (DLQI)	The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.	Baseline, Week 50, Week 62, Week 78, Week 98
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase	The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.	Week 50, Week 62, Week 78, Week 98
Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98	Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively.	Week 98
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age	Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.	Week 50
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender	Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.	Week 50
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race	Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.	Week 50
Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline	Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.	Week 50
Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline	Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline..	Week 50

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Shear NH, Hartmann M, Toledo-Bahena M, Katsambas A, Connors L, Chang Q, Yao R, Nograles K, Popmihajlov Z; REALITY investigators. Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice. Br J Dermatol. 2014 Sep;171(3):631-41. doi: 10.1111/bjd.13004. Epub 2014 Aug 13.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 23, 2008
• First Submitted That Met QC Criteria: October 23, 2008
• First Posted (Estimate): October 24, 2008

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: P05319; MK-2155-139 (Other Identifier: Merck Study Number)