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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Hidradenitis Suppurativa (HS) | Participants who along with their treating physician have elected for treatment with Humira as per routine clinical practice for the treatment of HS |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who reported any serious infections during the study | Percentage of participants with incidence of serious infections are reported. | 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. | Up to Week 52 |
| Percentage of participants who reported any infections during the study | Percentage of participants with incidence of infections are reported. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 52 |
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) |
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Inclusion Criteria:
Exclusion Criteria:
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Hidradenitis Suppurativa (HS)
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjou Kousei Hospital /ID# 216741 | Anjo-shi | Aichi-ken | 446-8602 | Japan | ||
| Ichinomiya Municipal Hospital /ID# 214086 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37264993 | Derived | Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. J Dermatol. 2023 Aug;50(8):1034-1044. doi: 10.1111/1346-8138.16835. Epub 2023 Jun 2. | |
| 35040156 |
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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. |
| Up to week 52 |
| Change in C-Reactive Protein (CRP) | CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation. | 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." | 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. | From Baseline to Week 52 |
| Ichinomiya-shi |
| Aichi-ken |
| 491-8558 |
| Japan |
| Aichi Medical University Hospital /ID# 215312 | Nagakute-shi | Aichi-ken | 480-1195 | Japan |
| NHO Nagoya Medical Center /ID# 214406 | Nagoya | Aichi-ken | 460-0001 | Japan |
| Nagoya University Hospital /ID# 214135 | Nagoya | Aichi-ken | 4668560 | Japan |
| Kimitsu Chuo Hospital /ID# 214733 | Kisarazu-shi | Chiba | 292-8535 | Japan |
| Ehime University Hospital /ID# 214090 | Toon-shi | Ehime | 791-0295 | Japan |
| Kyushu University Hospital /ID# 214092 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137 | Kitakyushu-shi | Fukuoka | 807-8556 | Japan |
| JA Hiroshima General Hospital /ID# 213472 | Hatsukaichi-shi | Hiroshima | 738-8503 | Japan |
| Sapporo Higashi Tokushukai Hospital /ID# 213865 | Sapporo | Hokkaido | 065-0033 | Japan |
| Kobe University Hospital /ID# 215642 | Kobe | Hyōgo | 650-0017 | Japan |
| Bito Dermatology Clinic /ID# 215316 | Kobe | Hyōgo | 651-0095 | Japan |
| Takarazuka City Hospital /ID# 214088 | Takarazuka-shi | Hyōgo | 665-0827 | Japan |
| Mito Kyodo General Hospital /ID# 214089 | Mito | Ibaraki | 310-0015 | Japan |
| Yokohama City University Medical Center /ID# 216740 | Yokohama | Kanagawa | 232-0024 | Japan |
| Yokosuka Kyosai Hospital /ID# 215310 | Yokosuka-shi | Kanagawa | 238-8558 | Japan |
| Kochi Medical School Hospital /ID# 214091 | Nankoku-shi | Kochi | 783-8505 | Japan |
| Kyoto University Hospital /ID# 215315 | Kyoto | Kyoto | 606-8507 | Japan |
| Yokkaichi Municipal Hospital /ID# 215641 | Yokkaichi-shi | Mie-ken | 510-0822 | Japan |
| Tohoku University Hospital /ID# 217830 | Sendai | Miyagi | 9808574 | Japan |
| Tohoku Rosai Hospital /ID# 214084 | Sendai | Miyagi | 981-8563 | Japan |
| Nara Hospital Kinki University Faculty of Medicine, /ID# 218640 | Ikoma-shi | Nara | 630-0227 | Japan |
| Okayama University Hospital /ID# 215317 | Okayama | Okayama-ken | 700-8558 | Japan |
| University of the Ryukyus Hospital /ID# 214136 | Nakagami-gun | Okinawa | 903-0215 | Japan |
| Kishiwada City Hospital /ID# 213471 | Kishiwada-shi | Osaka | 596-8501 | Japan |
| Kindai University Hospital /ID# 217831 | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Osaka University Hospital /ID# 215314 | Suita-shi | Osaka | 565-0871 | Japan |
| Osaka Medical and Pharmaceutical University Hospital /ID# 214087 | Takatsuki-shi | Osaka | 569-8686 | Japan |
| Saitama Medical University Hospital /ID# 215599 | Iruma-gun | Saitama | 350-0495 | Japan |
| Saitama Medical Center /ID# 218639 | Kawagoe-shi | Saitama | 350-8550 | Japan |
| JA Shizuoka Kohseiren Ensh Hospital /ID# 218160 | Hamamatsu | Shizuoka | 430-0929 | Japan |
| Shizuoka City Shizuoka Hospital /ID# 217292 | Shizuoka | Shizuoka | 420-0853 | Japan |
| Toranomon Hospital /ID# 213470 | Minato-ku | Tokyo | 105-8470 | Japan |
| Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134 | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Toyama University Hospital /ID# 214407 | Toyama | Toyama | 930-0194 | Japan |
| Japanese Red Cross Kitami Hospital /ID# 214085 | Hokkaido | 078-8510 | Japan |
| Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan. J Dermatol. 2022 Apr;49(4):411-421. doi: 10.1111/1346-8138.16297. Epub 2022 Jan 17. |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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