Weekly Top News – Psoriasis – October 21, 2019

October 21, 2019
Psoriasis

Tremfya (guselkumab) / J&JJanssen presents new four-year Tremfya (guselkumab) data demonstrating maintained rates of skin clearance in adult patients with moderate to severe plaque psoriasis (PRNewswire) - Oct 17, 2019 - P3, N=837; VOYAGE 1 (NCT02207231); Sponsor: Janssen; "The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the Phase 3 VOYAGE 1 clinical trial. These data showed that 82 percent of patients receiving TREMFYA® (guselkumab) in the combined group of patients initially randomized to TREMFYA or to placebo with crossover to TREMFYA at week 16 achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) response and an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 204 (4 years)....The data are being presented at the 39th Fall Clinical Dermatology Conference in Las Vegas, Nevada."Tremfya (guselkumab) / J&JGuselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind, Placebo-controlled Study (ACR-ARHP 2019) - Oct 19, 2019 - Pres time: Nov 12, 2019; 09:00 AM - 11:00 AM; Location: Hall B5; "In pts with active PsA, GUS Q4W and Q8W significantly improved joint and skin symptoms, physical function, and quality of life, and resolved enthesitis/dactylitis. GUS Q4W significantly reduced radiographic damage progression vs. PBO."Tremfya (guselkumab) / J&JGuselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind, Placebo-controlled Study (ACR-ARHP 2019) - Oct 19, 2019 - Abstract #L13; Pres time: Nov 12, 2019; 09:00 AM - 11:00 AM; Location: Hall B5; "In pts with active PsA, GUS Q4W and Q8W significantly improved joint and skin symptoms, physical function, and quality of life, and resolved enthesitis/dactylitis. GUS Q4W significantly reduced radiographic damage progression vs. PBO."Stelara (ustekinumab) / J&J; bimekizumab (UCB4940) / UCBBimekizumab phase 3 psoriasis study meets all endpoints, achieving significantly greater efficacy versus placebo and ustekinumab (PRNewswire) - Oct 17, 2019 - P3, N=570; BE VIVID (NCT03370133); Sponsor: UCB Biopharma; "UCB...today announced positive results from BE VIVID, the first of three Phase 3 studies evaluating the efficacy and safety of bimekizumab...in the treatment of adults with moderate-to-severe chronic plaque psoriasis....We look forward to sharing further findings from the bimekizumab clinical development program in the coming months."Xeljanz (tofacitinib) / PfizerTofacitinib as Monotherapy Following Methotrexate Withdrawal in Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL Balance (ACR-ARHP 2019) - Oct 19, 2019 - Abstract #L14; Pres time: Nov 12, 2019; 09:00 AM - 11:00 AM; Location: Hall B5; P3; "In general, no clinically meaningful differences in efficacy and safety were observed in pts with PsA who received OL tofacitinib 5 mg BID as monotherapy after MTX withdrawal vs with continued MTX. No new safety risks were identified. Limitations include that the sub‑study was designed as an estimation study and not powered for hypothesis testing, and only pts on long-term treatment who had responded well to, and tolerated, tofacitinib and MTX were included."Xeljanz (tofacitinib) / PfizerTofacitinib as Monotherapy Following Methotrexate Withdrawal in Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL Balance (ACR-ARHP 2019) - Oct 19, 2019 - Pres time: Nov 12, 2019; 09:00 AM - 11:00 AM; Location: Hall B5; P3; "In general, no clinically meaningful differences in efficacy and safety were observed in pts with PsA who received OL tofacitinib 5 mg BID as monotherapy after MTX withdrawal vs with continued MTX. No new safety risks were identified. Limitations include that the sub‑study was designed as an estimation study and not powered for hypothesis testing, and only pts on long-term treatment who had responded well to, and tolerated, tofacitinib and MTX were included."GSK2831781 / GSKGSK2831781 clinical trial estimate: Primary completion of P1 trial for healthy volunteers in Japan in January 2020 (GlobalData) - Oct 21, 2019 - A subscription to Thomson ONE is required to gain full access to report 67598395; Page no: 176; REPORT TITLE: "Immutep Ltd (IMM) - Financial analysis review”; AUTHOR: Globaldata; DATE: 09/24/2019MP1032 / MetrioPharmMetrioPharm AG phase II data in psoriasis show dose-response, disease modifying activity and outstanding safety profile (MetrioPharm Press Release) - Oct 16, 2019 - P2, N=153; NCT03706209; Sponsor: MetrioPharm AG; "MetrioPharm AG...reports positive results from its recently completed Phase II dose finding study of MP1032 in psoriasis patients....The overall response rate (defined as PASI 50 and 75) more than doubled over placebo with even a 4-fold increase in PASI 75 responders....High dose MP1032 showed a statistically significant reduction in all-cause AEs over placebo thereby confirming the expected benign safety profile."Otezla (apremilast) / AmgenOtezla ex-US sales projection: $300-400M in 2019 (Jefferies) - Oct 17, 2019 - A subscription to Thomson ONE is required to gain full access to report 68079059; Page no: 30; REPORT TITLE: "Q3 EPS and thoughts into year-end”; AUTHOR: Yee, Michael, et al; DATE: 10/10/2019Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin; Duobrii (halobetasol/tazarotene) / Bausch Health; Jemdel (halobetasol propionate topical) / Bausch HealthBausch Health's Ortho Dermatologics business to present data at the Fall Clinical Dermatology Conference (PRNewswire) - Oct 15, 2019 - "Bausch Health Companies...Ortho Dermatologics...today announced the presentation of 18 posters during the Fall Clinical Dermatology Conference in Las Vegas (Oct. 17-20, 2019). The presentations will feature analyse...BRYHALI® (halobetasol propionate 0.01%) Lotion, DUOBRII® (halobetasol propionate 0.01% and tazarotene 0.045%) Lotion and SILIQ (brodalumab) injection, as well as a new data on the investigational drug IDP-123 (tazarotene 0.045%) Lotion."