Bristol-Myers Squibb Company — Sotyktu EMA EPAR variation assessment report (EMEA/H/C/005755, 2023)
Bristol-Myers Squibb Company · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
Bristol-Myers Squibb's Type II variation application for Sotyktu (deucravacitinib) seeks to extend its indication to active psoriatic arthritis (PsA) in adults unresponsive to prior DMARDs. Supported by Phase 3 studies (POETYK PsA-1 and POETYK PsA-2), the application includes updated product information and risk management. Pharmacokinetic analysis confirmed the 6 mg once-daily dose, demonstrating efficacy in reducing PsA biomarkers and achieving ACR20/50/70 responses. Both Phase 3 trials (IM011054 and IM011055) showed statistically significant improvements in ACR20 response rates and other key endpoints (HAQ-DI, PASI 75, SF-36 PCS, MDA) compared to placebo at Week 16, with sustained efficacy up to Week 52. The safety profile, consistent with its use in psoriasis, revealed higher overall adverse events with deucravacitinib compared to placebo in the short term, though serious adverse events were comparable. New adverse reactions like pneumonia and bronchitis were added to the SmPC. Important risks such as MACE, VTE, and malignancies are under continued monitoring. The indication was restricted to use alone or with methotrexate due to limited evidence with other csDMARDs.
Key findings — cited to the page
| Incidence of shifts of > 2 CTC grades in fasting triglyceride levels | 1 patient | · p.137 |
| Incidence of shifts of > 2 CTC grades in fasting triglyceride levels (Grade 0 to 3) | 0.2 % | · p.137 |
| Incidence of shifts of > 2 CTC grades in fasting triglyceride levels (Grade 1 to 4) | 0.2 % | · p.137 |
| Geometric mean DEUC Cavgss change in PsA patients > 65 years vs ≤ 65 years | < 20 % | · p.21 |
| CHMP Scientific Advice date | July 2018 | · p.6 |
| CHMP Scientific Advice date | January 2021 | · p.7 |
| Study IM011-055 (POETYK PsA-2) phase | phase 3 | POETYK PsA-2 · p.6 |
| Approved dose for moderate to severe plaque psoriasis | 6 mg QD | Sotyktu · p.10 |
| Number of subjects included in PPK model | 1685 | · p.13 |
| Percentage of participants with PsA in PPK model | 78.6 % | · p.13 |
| Accumulation ratio of DEUC | 1.3 | · p.18 |
| Sotyktu EU Marketing Authorisation date | 24-Mar-2023 | Sotyktu · EU · p.10 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →