dm+d

Unassigned

New Medicines

SotyktuModerate-to-severe plaque psoriasis

Information

Sotyktu
New molecular entity
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Approved (Licensed)
Sep 22Approved in US for the ´treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy´. BMS plan to launch later this month, with a list price of $6,164 for a 30-day supply [15].
Nov 21US FDA accept filing and assign PDUFA date of Sep 22 [13].
Oct 21Filed in EU via centralised procedure [12].
Apr 21Filings are planned based on results of POETYK PSO-1 and POETYK PSO-2. Approval and launches predicted for early 2022 [11].
Mar 21Full data from the Poetyk-PSO-1 study is expected later this year, with the confirmatory 1,000-patient Poetyk-PSO-2 trial also due to report in the coming weeks [10].
Feb 21Deucravacitinib is considered by analysts to be the fifth most anticipated drug launch of 2021 in the US, a competitor to Otezla [9].
Nov 20Fillings not anticipated until late 2021 with possible launch anticipated for 2022-2023 [7].

Category

TYK2 inhibitor. Tyrosine kinase 2 (TYK2) is a member of the Janus kinase (JAK) family.
Prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. It can occur at any age but the majority of cases first present before the age of 35 years. It is uncommon in children. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Moderate-to-severe plaque psoriasis
Oral

Further information

Yes

Trial or other data

May 22BMS presents data from new long-term extension POETYK PSO-LTE trial (n>1,200) showing that 6mg of deucravacitinib once daily maintained clinical efficacy for up to 2 years of treatment. After 60 weeks, the response rate for reaching 75 on PASI was 77.7% with 58.7% of patients assessed as having clear or almost clear skin. [14].
Apr 21In trials POETYK PSO-1 and POETYK PSO-2 deucravacitinib was superior to placebo and Otezla. Specifically, deucravacitinib showed superior skin clearance compared with Otezla for key secondary endpoints, including PASI 75 and sPGA 0/1 responses at week 16, with an increased benefit versus Otezla at week 24 and maintained through week 52. In addition to PASI 75 and sPGA 0/1 measures, deucravacitinib was superior to Otezla across both studies in multiple other secondary endpoints, demonstrating significant and clinically meaningful efficacy improvements in symptom burden and quality of life measures. P values were not shared [11].
Feb 21BMS announce that in PIII POETYK-PSO-2 (NCT03611751; n=1,020) significantly more patients with moderate to severe plaque psoriasis had a PASI75 with deucravacitinib vs. placebo and apremilast[8].
Nov 20BMS announce that deucravacitinib has outperformed apremilast in the PIII POETYK-PSO-2 study (NCT03611751). So far the study has enrolled 666 patients to receive deucravacitinib, apremilast or placebo. Full results are yet to be released [7].
Apr 20PIII POETYK-PSO-3 is recruiting participants; the study plans to recruit 180 participants, and will evaluate the efficacy of BMS-986165 compared to placebo in participants with moderate to severe plaque psoriasis. The estimated primary completion date is August 2020 [6].
Nov 19The estimated primary completion date for PIII trials POETYK-PSO-1 (NCT03624127) and POETYK-PSO-2 (NCT03611751) is July 2020 [5].
Jul 18PIII POETYK-PSO-2 study (NCT03611751) to evaluate the efficacy and safety of BMS 986165 compared to placebo/apremilast in adults with plaque psoriasis starts. The multi-center, randomised, double-blind study intends to enrol approximately 1000 patients. Collection of primary outcome data (Percentage of participants who achieve sPGA score of 0 to 1 response and percentage of participants who achieve PASI 75 at week 16 is due to complete Jul 20 [3,4].
Jul 18PIII POETYK-PSO-1 study to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis starts (NCT03624127). 200 adults will be recruited from sites around the world including the US & EU (incl. UK). Collection of primary outcome data (Percentage of participants who achieve static Physician´s Global Assessment [sPGA] score of 0 to 1 response and percentage of participants who achieve PASI 75 at week 16) is due to complete Jul 20 [2].

Evidence based evaluations

SotyktuPsoriatic arthritis in adults

Information

Sotyktu
Licence extension / variation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

TYK2 inhibitor. Tyrosine kinase 2 (TYK2) is a member of the Janus kinase (JAK) family.
Psoriatic arthritis is a chronic inflammatory arthritis that affects about 5-25% of patients with psoriasis. The prevalence varies from 20-420 per 100,000 population across the world, except in Japan where it is 1 per 100,000. In about 80% of cases the presence of psoriasis precedes the onset of psoriatic arthritis [1].
Psoriatic arthritis in adults
Oral