The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.
Study Type
OBSERVATIONAL
Enrollment
46
Percentage of participants who reported any serious infections during the study
Percentage of participants with incidence of serious infections are reported.
Time frame: Up to Week 52
Percentage of participants who reported any adverse drug reactions (ADRs) during the study
ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Time frame: Up to Week 52
Percentage of participants who reported any infections during the study
Percentage of participants with incidence of infections are reported.
Time frame: Up to Week 52
Percentage of participants achieving "Improved" of overall improvement by physician
Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician.
Time frame: Up to Week 52
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
HiSCR is defined as at least 50% reduction in the number of abscesses and inflammatory nodules and no increase in abscess count and no increase in draining fistula count relative to baseline.
Time frame: Up to week 52
Change in C-Reactive Protein (CRP)
CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation.
Time frame: From Baseline to Week 52
Change in Patient's global assessment of skin pain
Patient's global assessment of skin pain is evaluated on a 11-point scale with 0 for "no pain" and 10 for "worst skin pain imaginable."
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Anjou Kousei Hospital /ID# 216741
Anjo-shi, Aichi-ken, Japan
Ichinomiya Municipal Hospital /ID# 214086
Ichinomiya-shi, Aichi-ken, Japan
Aichi Medical University Hospital /ID# 215312
Nagakute-shi, Aichi-ken, Japan
NHO Nagoya Medical Center /ID# 214406
Nagoya, Aichi-ken, Japan
Nagoya University Hospital /ID# 214135
Nagoya, Aichi-ken, Japan
Kimitsu Chuo Hospital /ID# 214733
Kisarazu-shi, Chiba, Japan
Ehime University Hospital /ID# 214090
Toon-shi, Ehime, Japan
Kyushu University Hospital /ID# 214092
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137
Kitakyushu-shi, Fukuoka, Japan
JA Hiroshima General Hospital /ID# 213472
Hatsukaichi-shi, Hiroshima, Japan
...and 27 more locations
Time frame: From Baseline to Week 52
Change in Dermatology Life Quality Index (DLQI)
DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life.
Time frame: From Baseline to Week 52