PMID- 37750995
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231031
IS  - 2193-8210 (Print)
IS  - 2190-9172 (Electronic)
VI  - 13
IP  - 11
DP  - 2023 Nov
TI  - Five-year Maintenance of Clinical Response and Consistent Safety Profile for 
      Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2.
PG  - 2721-2737
LID - 10.1007/s13555-023-01026-7 [doi]
AB  - INTRODUCTION: Guselkumab is a human monoclonal antibody against IL-23 used in the 
      treatment of moderate-to-severe psoriasis. This post-hoc analysis evaluated the 
      efficacy and safety of guselkumab in the Asian subpopulation of VOYAGE 1 and 
      VOYAGE 2 through 5 years. METHODS: The proportions of guselkumab-treated Asian 
      patients (VOYAGE 1 and 2) achieving Psoriasis Area and Severity Index (PASI) 90 
      and PASI 100, Investigator's Global Assessment (IGA) scores of 0/1 and 0, and 
      Dermatology Life Quality Index (DLQI) scores of 0/1 (week 100 through week 252) 
      were assessed. Non-responders were patients who met the treatment failure rules. 
      Efficacy endpoints were analyzed using the as-observed methodology (no missing 
      data imputation) for both studies and using non-responder imputation (for 
      patients with any missing data) in VOYAGE 1. Safety outcomes were based on pooled 
      data through week 252. RESULTS: Response rates through week 252 for 199 Asian 
      patients in the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 
      76.8% and 80.6% (PASI 90), 26.8% and 38.7% (PASI 100), 64.3% and 87.1% (IGA 0/1), 
      and 26.8% and 45.2% (IGA 0). DLQI (0/1) at week 252 was achieved by 52.7% of 
      patients in VOYAGE 1 and 61.3% in VOYAGE 2, while DLQI (0) at week 252 was 
      achieved by 32.7% of patients in VOYAGE 1 and 40.3% in VOYAGE 2. The safety 
      profile was similar to the global population and remained consistent through 
      5 years. Asian patients were followed for a total of 814 patient-years (PY). Over 
      85% of the guselkumab-treated patients continued treatment through week 264. The 
      rate of serious adverse events (AEs) at week 252 was 3.07/100 PY. Rates of AEs of 
      interest were low: serious infections, 0.74/100 PY; nonmelanoma skin cancer 
      (NMSC), no patients; malignancies other than NMSC, 0.12/100 PY; and no major 
      adverse cardiovascular events (MACE). CONCLUSION: These analyses confirm a 
      continuous response over 5 years, indicating that guselkumab shows therapeutic 
      longevity in Asian patients requiring long-term treatment for moderate-to-severe 
      psoriasis. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: VOYAGE 1 
      [NCT02207231] and VOYAGE 2 [NCT02207244].
CI  - (c) 2023. The Author(s).
FAU - Kim, Byung Soo
AU  - Kim BS
AD  - Department of Dermatology, College of Medicine, Pusan National University, 179, 
      Gudeok-ro, Seo-gu, Busan, 49241, Republic of Korea.
FAU - Jo, Seong Jin
AU  - Jo SJ
AD  - Department of Dermatology, Seoul National University Hospital, Seoul National 
      University College of Medicine, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic 
      of Korea.
FAU - Youn, SangWoong
AU  - Youn S
AD  - Department of Dermatology, Seoul National University Bundang Hospital, Seoul 
      National University College of Medicine, 82 Gumi-ro 173Beon-gil, Bundang-gu, 
      Seongnam-si, Gyeonggi-do, 13620, Republic of Korea.
FAU - Reich, Kristian
AU  - Reich K
AD  - Translational Research in Inflammatory Skin Diseases, Institute for Health 
      Services Research in Dermatology and Nursing, University Medical Center 
      Hamburg-Eppendorf, Hamburg, Germany.
FAU - Saadoun, Carine
AU  - Saadoun C
AD  - Regional Medical Affairs Janssen Asia Pacific, Janssen, a division of Johnson & 
      Johnson Pte Ltd., 2 Science Park Drive, #07-13, Ascent, Singapore Science Park 1, 
      Singapore, 118222, Singapore.
FAU - Chang, Chia-Ling
AU  - Chang CL
AD  - Regional Medical Affairs Janssen Asia Pacific, Janssen, a division of Johnson & 
      Johnson Pte Ltd., 2 Science Park Drive, #07-13, Ascent, Singapore Science Park 1, 
      Singapore, 118222, Singapore.
FAU - Yang, Ya-Wen
AU  - Yang YW
AD  - Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, 
      LLC, Horsham, PA, USA.
FAU - Huang, Yu-Huei
AU  - Huang YH
AD  - Department of Dermatology, Chang Gung Memorial Hospital and College of Medicine, 
      Chang Gung University, Guishan District, Taoyuan City, Taiwan.
FAU - Tsai, Tsen-Fang
AU  - Tsai TF
AUID- ORCID: 0000-0002-1498-1474
AD  - Department of Dermatology, National Taiwan University Hospital, No. 7, Chung-Shan 
      S. Road, Taipei, 100, Taiwan. tftsai@yahoo.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02207231
SI  - ClinicalTrials.gov/NCT02207244
PT  - Journal Article
DEP - 20230926
PL  - Switzerland
TA  - Dermatol Ther (Heidelb)
JT  - Dermatology and therapy
JID - 101590450
PMC - PMC10613179
OAB - Psoriasis-a long-term condition that causes a skin rash with scaly, itchy patches 
      (plaques)-is becoming more prevalent in Asia. To control symptoms of 
      moderate-to-severe psoriasis and achieve a strong improvement in the patient's 
      quality of life, continuous treatment is usually needed. Guselkumab is a medicine 
      that targets specific parts of the immune system to treat moderate-to-severe 
      psoriasis. It is important to understand the long-term benefits of guselkumab in 
      Asian patient populations. Our study analyzed the data from two randomized 
      clinical trials (called VOYAGE 1 and VOYAGE 2) that studied people with 
      moderate-to-severe plaque psoriasis. We examined results for the 199 people from 
      Asia, including Korea and Taiwan, who took part in these studies. Overall, 162 of 
      the 184 (86.6%) people from Asia treated with guselkumab incorporated into these 
      studies continued the treatment for 5 years. Patients treated with guselkumab 
      showed effective clinical responses (improvements measured by clinicians), 
      including high skin clearance, meaning a large reduction in skin surface area 
      affected by psoriasis. On guselkumab, patients also reported improvements in 
      their skin-related health-related quality of life. These improvements and the 
      efficacy of guselkumab were maintained over 5 years of follow-up. The safety 
      results for guselkumab in the Asian subpopulation were similar to those for the 
      global population, showing low rates of serious adverse effects, as expected from 
      this type of medicine. Overall, our study found a favorable benefit-risk profile 
      with continuous guselkumab treatment for 5 years in Asian people with 
      moderate-to-severe psoriasis. This highlights that guselkumab treatment allows 
      long-lasting control of this disease.
OABL- eng
OTO - NOTNLM
OT  - Asian
OT  - Biologics
OT  - Guselkumab
OT  - Moderate-to-severe
OT  - Psoriasis
COIS- Byung Soo Kim has served as a scientific adviser, a clinical study investigator 
      and/or a speaker for AbbVie, Astellas, Boehringer Ingelheim, Bristol Myers 
      Squibb, Celltrion, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Kyowa Hakko 
      Kirin, LEO Pharma, Novartis, Regeneron, Samsung, Sanofi and UCB. Seong-Jin Jo has 
      conducted clinical trials for, acted as a consultant for, or received speaker's 
      honoraria from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Daewoong, 
      Janssen, LEO Pharma, Lilly, Novartis, Pfizer and Sanofi. SangWoong Youn served as 
      a speaker for AbbVie, Cellgene, Eli Lilly, Janssen, LEO Pharma, Novartis and 
      Pfizer organised psoriasis symposium or meetings, and has also performed phase 
      III clinical trials sponsored by Janssen, Novartis, Boehringer Ingelheim, BMS, 
      Eli Lilly, Kyowa Kirin and UCB and phase IV clinical trials sponsored by CKD 
      Pharma, Janssen and LEO Pharma. Kristian Reich has served as a paid advisor 
      and/or a paid speaker for and/or participated in clinical trials (site received 
      patient fees, received fees if acting as a coordinating investigator) sponsored 
      by AbbVie, Affibody, Almirall, Amgen, Biogen-Idec, Boehringer Ingelheim Pharma, 
      Celgene, Covagen, Forward Pharma, Fresenius Medical Care, Galderma, 
      GlaxoSmithKline, Janssen, Janssen-Cilag, Kyowa Kirin, Leo, Eli Lilly, Medac, 
      Merck Sharp & Dohme, Miltenyi, Novartis, Ocean Pharma, Pfizer, Samsung Bioepis, 
      Sanofi, Takeda, UCB Pharma, Valeant and Xenoport. Carine Saadoun, Chia-Ling Chang 
      and Ya-Wen Yang are employees of Janssen Pharmaceutical Companies of Johnson & 
      Johnson. Yu-Huei Huang has conducted clinical trials while serving as a principal 
      investigator for AbbVie, Galderma, Eli Lilly, Janssen-Cilag Pharmaceutica, 
      Novartis Pharmaceuticals Corporation and Pfizer and has received honoraria for 
      serving as an advisory board member for and speaking fees from AbbVie, Celgene, 
      Eli Lilly, Janssen-Cilag Pharmaceutica, Novartis Pharmaceuticals Corporation and 
      Pfizer Limited. Tsen-Fang Tsai has conducted clinical trials or received 
      honoraria for serving as a consultant for Abbvie, Boehringer Ingelheim, Bristol 
      Myers Squibb, Celgene, Eli-Lilly, Galderma, GSK, Janssen-Cilag, Leo Pharma, Merck 
      Sharp & Dohme, Novartis International, Pfizer, PharmaEssentia, Sanofi, and UCB 
      Pharma.
EDAT- 2023/09/26 13:43
MHDA- 2023/09/26 13:44
PMCR- 2023/09/26
CRDT- 2023/09/26 11:09
PHST- 2022/12/08 00:00 [received]
PHST- 2023/02/23 00:00 [accepted]
PHST- 2023/09/26 13:44 [medline]
PHST- 2023/09/26 13:43 [pubmed]
PHST- 2023/09/26 11:09 [entrez]
PHST- 2023/09/26 00:00 [pmc-release]
AID - 10.1007/s13555-023-01026-7 [pii]
AID - 1026 [pii]
AID - 10.1007/s13555-023-01026-7 [doi]
PST - ppublish
SO  - Dermatol Ther (Heidelb). 2023 Nov;13(11):2721-2737. doi: 
      10.1007/s13555-023-01026-7. Epub 2023 Sep 26.