Yoshinori Umezawa1, Akihiko Asahina1, Shinichi Imafuku2, Yayoi Tada3, Shigetoshi Sano4, Akimichi Morita5, Shinya Sakurai6, Naoki Hoshii7, Nicola Tilt8, Hidemi Nakagawa1. 1. Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan. 2. Department of Dermatology, Fukuoka University, Fukuoka, Japan. 3. Department of Dermatology, Teikyo University, Tokyo, Japan. 4. Department of Dermatology, Kochi Medical School, Kochi, Japan. 5. Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 6. UCB Japan Co., Ltd., 8 Chome-17-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. shinya.sakurai@ucb.com. 7. UCB Japan Co., Ltd., 8 Chome-17-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. 8. UCB Pharma, Brussels, Belgium.
Abstract
INTRODUCTION:Certolizumab pegol (CZP), an Fc-free, PEGylated anti-tumour necrosis factor biologic, dosed at 400 mg every 2 weeks (Q2W) and 200 mg Q2W over 16 weeks, resulted in improvements in Japanese patients with moderate to severe plaque psoriasis (PSO); no new safety signals were identified. We present 52-week efficacy and safety results. METHODS:Patients ≥ 20 years with PSO≥ 6 months [Psoriasis Area and Severity Index (PASI) ≥ 12, body surface area ≥ 10%, Physician's Global Assessment (PGA) ≥ 3] were randomised 1:2:2 to placebo Q2W, CZP 400 mg Q2W and CZP 200 mg Q2W (400 mg weeks 0/2/4) for 16 weeks. Week 16 PASI 50 responders continued through week 52; CZP 200 mg Q2W-randomised patients were re-randomised 1:1 to CZP 200 mg Q2W or CZP 400 mg Q4W; patients initially randomised to other treatment groups continued in the same group. Outcomes included PASI 75/90/100, PGA 0/1, Dermatology Life Quality Index (DLQI) 0/1, Itch Numeric Rating Scale (INRS) 0, modified Nail Psoriasis Severity Index (mNAPSI), durability of response for week 16 PASI 75/90 responders, and safety. RESULTS: Of 26/53/48 patients randomised to placebo, CZP 400 mg Q2W and CZP 200 mg Q2W, 2/47/39 completed week 52, respectively. PASI 75/90 responses were generally maintained from weeks 16 to 52 for all CZP doses. Most week 16 PASI 75/90 achievers maintained their response through week 52. PASI 75/90/100 responses at week 52 in the CZP 400 mg Q2W and CZP 200 mg Q2W groups were 83.0/81.1/41.5% and 72.9/60.4/18.8%, respectively; DLQI/INRS remission rates were 64.2/50.9% in CZP 400 mg Q2W and 58.3/27.1% in CZP 200 mg Q2W-treated patients. Reductions in mNAPSI observed for CZP-treated groups were maintained through week 52. No new safety signals were identified. CONCLUSION:CZP treatment resulted in improvements in signs and symptoms of PSO, which were maintained through week 52. The 400 mg Q2W dose could provide additional clinical benefit. TRIAL REGISTRATION: NCT03051217.
RCT Entities:
INTRODUCTION:Certolizumab pegol (CZP), an Fc-free, PEGylated anti-tumour necrosis factor biologic, dosed at 400 mg every 2 weeks (Q2W) and 200 mg Q2W over 16 weeks, resulted in improvements in Japanese patients with moderate to severe plaque psoriasis (PSO); no new safety signals were identified. We present 52-week efficacy and safety results. METHODS:Patients ≥ 20 years with PSO ≥ 6 months [Psoriasis Area and Severity Index (PASI) ≥ 12, body surface area ≥ 10%, Physician's Global Assessment (PGA) ≥ 3] were randomised 1:2:2 to placebo Q2W, CZP 400 mg Q2W and CZP 200 mg Q2W (400 mg weeks 0/2/4) for 16 weeks. Week 16 PASI 50 responders continued through week 52; CZP 200 mg Q2W-randomised patients were re-randomised 1:1 to CZP 200 mg Q2W or CZP 400 mg Q4W; patients initially randomised to other treatment groups continued in the same group. Outcomes included PASI 75/90/100, PGA 0/1, Dermatology Life Quality Index (DLQI) 0/1, Itch Numeric Rating Scale (INRS) 0, modified Nail Psoriasis Severity Index (mNAPSI), durability of response for week 16 PASI 75/90 responders, and safety. RESULTS: Of 26/53/48 patients randomised to placebo, CZP 400 mg Q2W and CZP 200 mg Q2W, 2/47/39 completed week 52, respectively. PASI 75/90 responses were generally maintained from weeks 16 to 52 for all CZP doses. Most week 16 PASI 75/90 achievers maintained their response through week 52. PASI 75/90/100 responses at week 52 in the CZP 400 mg Q2W and CZP 200 mg Q2W groups were 83.0/81.1/41.5% and 72.9/60.4/18.8%, respectively; DLQI/INRS remission rates were 64.2/50.9% in CZP 400 mg Q2W and 58.3/27.1% in CZP 200 mg Q2W-treated patients. Reductions in mNAPSI observed for CZP-treated groups were maintained through week 52. No new safety signals were identified. CONCLUSION:CZP treatment resulted in improvements in signs and symptoms of PSO, which were maintained through week 52. The 400 mg Q2W dose could provide additional clinical benefit. TRIAL REGISTRATION: NCT03051217.
Authors: Sarah E Cassell; Jeffry D Bieber; Phoebe Rich; Zuhre N Tutuncu; Susan J Lee; Kenneth C Kalunian; Christopher W Wu; Arthur Kavanaugh Journal: J Rheumatol Date: 2007-01 Impact factor: 4.666
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Authors: A Wollenberg; A Blauvelt; E Guttman-Yassky; M Worm; C Lynde; J-P Lacour; L Spelman; N Katoh; H Saeki; Y Poulin; A Lesiak; L Kircik; S H Cho; P Herranz; M J Cork; K Peris; L A Steffensen; B Bang; A Kuznetsova; T N Jensen; M L Østerdal; E L Simpson Journal: Br J Dermatol Date: 2020-12-30 Impact factor: 9.302