N/A
Completed N=595
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
Source: ClinicalTrials.gov NCT01387815 ↗Enrolled (actual)
595
Serious AEs
3.8%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 — 31.4; 56.3 percentage of participants — p=<0.001
Summary
This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 |
31.4; 56.3 | <0.001 sig |
| SECONDARY Time to Achieving PGA ≤ 1 |
13.3; 5.7 | <0.001 sig |
| SECONDARY PGA≤1: Percentage of Participants at Month 3 |
19.0; 47.5 | <0.001 sig |
| SECONDARY PGA≤1: Percentage of Participants at Month 12 |
34.5; 57.3 | <0.001 sig |
| SECONDARY PGA≤1: Percentage of Participants at Month 18 |
35.7; 61.3 | <0.001 sig |
| SECONDARY PGA≤1: Percentage of Participants at Month 24 |
37.5; 56.7 | <0.001 sig |
| SECONDARY Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3 |
6.3; 7.6 | 0.003 sig |
| SECONDARY PASQ Total Score: Change From Baseline to Month 6 |
6.3; 7.5 | 0.016 sig |
| SECONDARY PASQ Total Score: Change From Baseline to Month 12 |
6.6; 7.6 | 0.060 |
| SECONDARY PASQ Total Score: Change From Baseline to Month 18 |
6.9; 7.9 | 0.056 |
| SECONDARY PASQ Total Score: Change From Baseline to Month 24 |
7.2; 7.4 | 0.755 |
| SECONDARY Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6 |
6.4; 4.9 | 0.091 |
| SECONDARY BSA of Psoriasis Involvement: Change From Baseline to Month 12 |
5.4; 4.1 | 0.106 |
| SECONDARY BSA of Psoriasis Involvement: Change From Baseline to Month 18 |
5.1; 3.1 | 0.003 sig |
| SECONDARY BSA of Psoriasis Involvement: Change From Baseline to Month 24 |
6.3; 3.7 | 0.008 sig |
| SECONDARY Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3 |
37.3; 32.8 | 0.083 |
| SECONDARY PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6 |
31.8; 29.9 | 0.495 |
| SECONDARY PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12 |
32.9; 28.2 | 0.097 |
| SECONDARY PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18 |
30.2; 21.8 | 0.006 sig |
| SECONDARY PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24 |
31.9; 25.1 | 0.037 sig |
| SECONDARY Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3 |
6.5; 5.4 | 0.084 |
| SECONDARY DLQI Total Score: Change From Baseline to Month 6 |
5.3; 4.3 | 0.090 |
| SECONDARY DLQI Total Score: Change From Baseline to Month 12 |
5.1; 3.9 | 0.059 |
| SECONDARY DLQI Total Score: Change From Baseline to Month 18 |
4.0; 2.5 | 0.004 sig |
| SECONDARY DLQI Total Score: Change From Baseline to Month 24 |
4.3; 3.3 | 0.115 |
| SECONDARY Time to Achieving DLQI ≤1 |
17.7; 8.2 | 0.002 sig |
| SECONDARY DLQI ≤1: Percentage of Participants at Month 3 |
18.2; 31.1; 33.2; 21.4; 19.0; 15.6 | 0.002 sig |
| SECONDARY DLQI ≤1: Percentage of Participants at Month 6 |
26.5; 39.3; 28.7; 19.8; 13.5; 10.1 | 0.017 sig |
| SECONDARY DLQI ≤1: Percentage of Participants at Month 12 |
28.2; 37.9; 27.2; 24.2; 15.0; 7.5 | 0.010 sig |
| SECONDARY DLQI ≤1: Percentage of Participants at Month 18 |
35.7; 45.7; 25.7; 15.6; 12.9; 11.1 | 0.015 sig |
| SECONDARY DLQI ≤1: Percentage of Participants at Month 24 |
34.5; 38.1; 27.4; 20.1; 12.5; 9.8 | 0.060 |
| SECONDARY Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6 |
7.8; 7.2 | 0.501 |
| SECONDARY BDI-II: Change From Baseline to Month 12 |
7.5; 7.3 | 0.807 |
| SECONDARY BDI-II: Change From Baseline to Month 24 |
7.2; 6.6 | 0.479 |
| SECONDARY Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6 |
49.8; 49.7 | 0.918 |
| SECONDARY SF-12 MCS Score: Change From Baseline to Month 12 |
48.9; 49.6 | 0.609 |
| SECONDARY SF-12 MCS Score: Change From Baseline to Month 24 |
50.2; 51.3 | 0.367 |
| SECONDARY SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6 |
48.2; 47.3 | 0.521 |
| SECONDARY SF-12 PCS Score: Change From Baseline to Month 12 |
47.3; 47.0 | 0.793 |
| SECONDARY SF-12 PCS Score: Change From Baseline to Month 24 |
47.8; 48.8 | 0.442 |
| SECONDARY Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6 |
12.4; 14.0 | 0.434 |
| SECONDARY WLQ Total Score: Change From Baseline to Month 12 |
13.5; 14.2 | 0.752 |
| SECONDARY WLQ Total Score: Change From Baseline to Month 24 |
12.1; 10.4 | 0.469 |
| SECONDARY WLQ Productivity Loss Score: Change From Baseline to Month 6 |
3.2; 3.6 | 0.419 |
| SECONDARY WLQ Productivity Loss Score: Change From Baseline to Month 12 |
3.5; 3.7 | 0.695 |
| SECONDARY WLQ Productivity Loss Score: Change From Baseline to Month 24 |
3.1; 2.7 | 0.452 |
| SECONDARY Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6 |
156; 177 | 0.008 sig |
| SECONDARY HCRU: Number of Participants With Insurance for Prescription Medication at Month 12 |
148; 157 | 0.181 |
| SECONDARY HCRU: Number of Participants With Insurance for Prescription Medication at Month 24 |
112; 121 | 0.252 |
| SECONDARY HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 |
14; 8; 8; 12; 17; 29 | — |
| SECONDARY HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 |
13; 6; 6; 6; 1; 0 | — |
| SECONDARY HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 |
8; 5; 7; 6; 16; 27 | — |
| SECONDARY HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 |
95; 86; 82; 101; 46; 60 | 0.143 |
| SECONDARY HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 |
89; 81; 81; 88; 36; 58 | 0.415 |
| SECONDARY HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 |
57; 55; 71; 78; 40; 61 | 0.604 |
| SECONDARY HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 |
7; 5; 71; 76; 145; 166 | 0.504 |
| SECONDARY HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 |
7; 7; 73; 69; 126; 151 | 0.920 |
| SECONDARY HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 |
3; 2; 51; 49; 114; 143 | >0.999 |
| SECONDARY HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 |
1.9; 1.3 | 0.575 |
| SECONDARY HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 |
1.0; NA | — |
| SECONDARY HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 |
7.0; NA | — |
| SECONDARY HCRU: Number of Participants Making Visits to Another Physician at Month 6 |
21; 20; 59; 60; 143; 167 | 0.856 |
| SECONDARY HCRU: Number of Participants Making Visits to Another Physician at Month 12 |
18; 14; 58; 55; 130; 158 | 0.623 |
| SECONDARY HCRU: Number of Participants Making Visits to Another Physician at Month 24 |
15; 16; 38; 35; 115; 143 | 0.732 |
| SECONDARY HCRU: Number of Visits to Another Physician at Month 6 |
1.4; 1.4 | 0.896 |
| SECONDARY HCRU: Number of Visits to Another Physician at Month 12 |
2.0; 2.2 | 0.879 |
| SECONDARY HCRU: Number of Visits to Another Physician at Month 24 |
1.2; 1.3 | 0.763 |
| SECONDARY HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 |
15; 12; 61; 59; 147; 176 | 0.657 |
| SECONDARY HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 |
13; 12; 60; 55; 133; 160 | 0.987 |
| SECONDARY HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 |
2; 10; 49; 39; 117; 145 | 0.011 sig |
| SECONDARY HCRU: Number of Visits to A Healthcare Professional at Month 6 |
1.3; 1.0 | 0.351 |
| SECONDARY HCRU: Number of Visits to A Healthcare Professional at Month 12 |
1.8; 1.5 | 0.835 |
| SECONDARY HCRU: Number of Visits to A Healthcare Professional at Month 24 |
1; 1.3 | — |
| SECONDARY HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 |
3; 4; 83; 77; 137; 166 | 0.714 |
| SECONDARY HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 |
4; 5; 82; 73; 120; 149 | 0.737 |
| SECONDARY HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 |
2; 3; 52; 51; 114; 140 | >0.999 |
| SECONDARY HCRU: Number of Visits to a Hospital Emergency Room at Month 6 |
1 | — |
| SECONDARY HCRU: Number of Visits to a Hospital Emergency Room at Month 12 |
1; 1 | — |
| SECONDARY HCRU: Number of Visits to a Hospital Emergency Room at Month 24 |
1 | — |
| SECONDARY HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 |
1; 0; 84; 81; 138; 166 | >0.999 |
| SECONDARY HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 |
1; 1; 85; 77; 120; 149 | >0.999 |
| SECONDARY HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 |
54; 54; 114; 140 | — |
| SECONDARY HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 |
3; 4; 84; 78; 136; 165 | 0.714 |
| SECONDARY HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 |
6; 4; 76; 73; 124; 150 | 0.747 |
| SECONDARY HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 |
0; 1; 54; 52; 114; 141 | 0.495 |
| SECONDARY HCRU: Number of Complementary/Alternate Therapy Visits at Month 6 |
3.0 | — |
| SECONDARY HCRU: Number of Complementary/Alternate Therapy Visits at Month 12 |
1; 1 | — |
| SECONDARY HCRU: Number of Complementary/Alternate Therapy Visits at Month 24 |
— | — |
| SECONDARY HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 |
3; 1; 177; 186; 43; 60 | 0.364 |
| SECONDARY HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 |
3; 3; 167; 172; 36; 52 | >0.999 |
| SECONDARY HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 |
3; 5; 130; 132; 35; 57 | 0.723 |
| SECONDARY HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6 |
8.3; 1 | — |
| SECONDARY HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12 |
1; 2.0 | — |
| SECONDARY HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24 |
1; 1 | — |
| SECONDARY HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 |
1; 0; 222; 247 | — |
| SECONDARY HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 |
0; 1; 206; 226 | — |
| SECONDARY HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24 |
— | — |
| SECONDARY HCRU: Cost of Payment for Over the Counter Medications at Month 6 |
35.0; 8.7 | 0.006 sig |
| SECONDARY HCRU: Cost of Payment for Over the Counter Medications at Month 12 |
17.8; 22.1 | 0.672 |
| SECONDARY HCRU: Cost of Payment for Over the Counter Medications at Month 24 |
10.8; 17.3 | 0.482 |
| SECONDARY HCRU: Cost of Payments to Healthcare Professionals at Month 6 |
4.0; 4.4 | 0.938 |
| SECONDARY HCRU: Cost of Payments to Healthcare Professionals at Month 12 |
31.2; 3.5 | 0.144 |
| SECONDARY HCRU: Cost of Payments to Healthcare Professionals at Month 24 |
7.9; 1.5 | 0.360 |
| SECONDARY HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6 |
2.0; 2.6 | 0.808 |
| SECONDARY HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12 |
0.0; 0.5 | 0.208 |
| SECONDARY HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24 |
0.4; 8.2 | 0.184 |
| SECONDARY HCRU: Cost of Payments for Medical Devices at Month 6 |
0.00; 0.4 | 0.305 |
| SECONDARY HCRU: Cost of Payments for Medical Devices at Month 12 |
0.0; 0.0 | — |
| SECONDARY HCRU: Cost of Payments for Medical Devices at Month 24 |
1.0; 1.5 | 0.757 |
| SECONDARY HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6 |
5.9; 0.0 | 0.321 |
| SECONDARY HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12 |
0.0; 1.4 | 0.181 |
| SECONDARY HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24 |
2.5; 18.5 | 0.395 |
| SECONDARY HCRU: Cost of Payments for Transportation at Month 6 |
20.4; 14.7 | — |
| SECONDARY HCRU: Cost of Payments for Transportation at Month 12 |
13.1; 15.5 | 0.739 |
| SECONDARY HCRU: Cost of Payments for Transportation at Month 24 |
22.1; 12.9 | 0.291 |
| SECONDARY Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 |
2.8; 2.2 | — |
| SECONDARY Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 |
4.8; 3.3 | — |
| SECONDARY Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 |
3.8; 0.6 | — |
| SECONDARY Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 |
5.0; 0.3 | — |
| SECONDARY Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 |
0.2; 0.1 | — |
| SECONDARY Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3 |
3.3; 2.5 | — |
| SECONDARY Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6 |
1.8; 4.7 | — |
| SECONDARY Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12 |
1.6; 1.3 | — |
| SECONDARY Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18 |
0.3; 2.7 | — |
| SECONDARY Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24 |
1.1; 10.0 | — |
| SECONDARY Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 |
2.7; 0.0 | — |
| SECONDARY Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 |
3.0; 0.1 | — |
| SECONDARY Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 |
2.0; 0.1 | — |
| SECONDARY Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 |
0.6; 0.1 | — |
| SECONDARY Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 |
1.4; 4.3 | — |
| SECONDARY Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 |
0.0; 0.2 | — |
| SECONDARY Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 |
1.2; 0.4 | — |
| SECONDARY Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 |
0.9; 0.6 | — |
| SECONDARY Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 |
0.1; 0.6 | — |
| SECONDARY Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 |
0.0; 0.4 | — |
| SECONDARY Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 |
76; 88; 167; 162; 4; 6 | — |
| SECONDARY Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 |
75; 75; 145; 168; 2; 3 | — |
| SECONDARY Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 |
55; 58; 139; 158; 7; 5 | — |
| SECONDARY Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 |
53; 37; 113; 158; 2; 1 | — |
| SECONDARY Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 |
51; 41; 111; 143; 2; 8 | — |
| SECONDARY Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 |
106; 88; 139; 166; 1; 1 | — |
| SECONDARY Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 |
108; 68; 113; 177; 1; 1 | — |
| SECONDARY Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 |
88; 63; 108; 157; 5; 1 | — |
| SECONDARY Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 |
65; 53; 102; 143; 1; 0 | — |
| SECONDARY Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 |
71; 44; 93; 145; 0; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Active moderate or severe plaque psoriasis according to the judgment of the treating physician.
- The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.
Exclusion Criteria
- Had currently participated in another prospective study with similar objectives.
- Participant could not or would not sign informed consent.
- Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.
Data sourced from ClinicalTrials.gov (NCT01387815). 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. Informational only — not medical advice.