N/A
Completed N=24
Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients
Source: ClinicalTrials.gov NCT02739828 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in DLQI at Week 12 — -7.8 score on a scale — p=0.0001
Summary
The objective of this study is to assess quality of life (QoL), skin pain, work productivity/activity and health related problems in Swedish patients with moderate to severe HS before and after 6 months treatment with Adalimumab. Participants will be treated in accordance with normal routine clinical care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in DLQI at Week 12 |
-7.8 | 0.0001 sig |
| SECONDARY Change From Baseline in DLQI at Week 4 |
-9.3 | < 0.0001 sig |
| SECONDARY Change From Baseline in DLQI at Week 24 |
-9.3 | 0.0004 sig |
| SECONDARY Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4 |
-3.2; -2.3 | 0.0005 sig |
| SECONDARY Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12 |
-2.9; -2.2 | 0.0004 sig |
| SECONDARY Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24 |
-2.8; -1.4 | 0.0003 sig |
| SECONDARY EQ-5D Questionnaire Responses at Week 4 |
17; 2; 18; 1; 16; 3 | — |
| SECONDARY EQ-5D Questionnaire Responses at Week 12 |
16; 2; 17; 1; 16; 2 | — |
| SECONDARY EQ-5D Questionnaire Responses at Week 24 |
14; 4; 17; 1; 15; 2 | — |
| SECONDARY Change From Baseline in EQ-5D VAS Score at Week 4 |
9.9 | 0.0278 sig |
| SECONDARY Change From Baseline in EQ-5D VAS Score at Week 12 |
11.4 | 0.0215 sig |
| SECONDARY Change From Baseline in EQ-5D VAS Score at Week 24 |
8.7 | 0.1652 |
| SECONDARY Change From Baseline in HSIA Overall Score at Week 4 |
-26.7 | — |
| SECONDARY Change From Baseline in HSIA Overall Score at Week 12 |
-27.1 | — |
| SECONDARY Change From Baseline in HSIA Overall Score at Week 24 |
-26 | — |
| SECONDARY WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4 |
-6.7 | 1.0000 |
| SECONDARY WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12 |
2 | 1.0000 |
| SECONDARY WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24 |
-13.1 | 0.5000 |
| SECONDARY WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4 |
-17.5 | 0.1797 |
| SECONDARY Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12 |
-15 | 0.4531 |
| SECONDARY Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24 |
-14 | 0.0313 sig |
| SECONDARY Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4 |
-17.4 | 0.3438 |
| SECONDARY Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12 |
-15 | 0.4531 |
| SECONDARY Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24 |
-16.2 | 0.0156 sig |
| SECONDARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4 |
-25 | 0.0386 sig |
| SECONDARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12 |
-16.2 | 0.3438 |
| SECONDARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24 |
-15 | 0.1250 |
| SECONDARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline |
-28 | 0.0625 |
| SECONDARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline |
-36 | 0.0625 |
| SECONDARY Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline |
-31.7 | 0.1250 |
| SECONDARY Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time |
73.7; 55.6; 61.1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Hidradenitis Suppurativa
- Prescribed Adalimumab according to the Summary of Product Characteristics (SmPC)
- Willingness to sign and date a Patient Information/Informed Consent Form
Exclusion Criteria
- Prior biologic treatment discontinued <6 months before the baseline visit
- Patient not able to understand the language of the provided patient questionnaires
- History of non-compliance with medication or a medical history that could enhance non-compliance with medication, as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT02739828). 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.