TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
Medical Information
TREMFYA - Occurrence of Thrombotic Events in the Treatment of Adult Patients with Psoriasis or Psoriatic Arthritis
Last Updated: 01/04/2025
SUMMARY
- Please refer to local labeling for relevant safety information regarding TREMFYA.
- Data on the occurrence of thrombotic events from phase 2 and phase 3/3b clinical trials of TREMFYA in patients with psoriasis (PsO) or active psoriatic arthritis (PsA) are summarized below.1
CLINICAL DATA
Pooled Analysis
A pooled analysis evaluated the incidence of thrombotic events observed with TREMFYA from 14 phase 2 and phase 3/3b clinical trials in patients with PsO or active PsA.1
- The pooled analysis included 9 phase 2 and phase 3/3b clinical trials in patients with plaque psoriasis, 1 phase 3b clinical trial in patients with palmoplantar non-pustular psoriasis, and 4 phase 2 and phase 3/3b clinical trials in patients with active PsA.
- For the incidence of arterial thrombosis adverse events in patients treated with TREMFYA, see Table: Incidence of Arterial Thrombosis Adverse Events in Patients Treated with TREMFYA.
| Psoriasis | Psoriatic Arthritis | |
|---|---|---|
| TREMFYA-treated patients, n | 3968 | 1508 |
| Total patient-years of follow-up | 9924.5 | 2125.2 |
| Number of arterial thrombosis AEsb | 37 | 6 |
| Arterial thrombosis events per 100 patient-years of follow-up (95% CI) | 0.37 (0.26-0.51) | 0.28 (0.10-0.61) |
| Abbreviations: AE, adverse event; CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities; SMQ, Standardized MedDRA Query. aAnalysis of arterial thrombosis incidence rates as of 31 December 2022. Arterial thrombosis AEs were identified based on the MedDRA Version 25.1 SMQ “embolic and thrombotic events, arterial” (narrow) excluding preferred terms that describe non-specific visual symptoms. bIn the analysis of arterial thrombosis events, for patients with multiple, contemporaneous arterial thrombosis AEs involving the same anatomic region (i.e. 2 events of myocardial infarction) the concurrent events were counted as a single, distinct arterial thrombosis event. | ||
- For the incidence of venous thrombosis adverse events in patients treated with TREMFYA, see Table: Incidence of Venous Thrombosis Adverse Events in Patients Treated with TREMFYA.
| Psoriasis | Psoriatic Arthritis | |
|---|---|---|
| TREMFYA-treated patients, n | 3968 | 1508 |
| Total patient-years of follow-up | 9924.5 | 2125.2 |
| Number of venous thrombosis AEsb | 9 | 5 |
| Venous thrombosis events per 100 patient-years of follow-up (95% CI) | 0.09 (0.04-0.17) | 0.24 (0.08-0.55) |
| Abbreviations: AE, adverse event; CI, confidence interval; DVT, deep vein thrombosis; MedDRA, Medical Dictionary for Regulatory Activities; PE, pulmonary embolism; SMQ, Standardized MedDRA Query. aAnalysis of venous thrombosis incidence rates as of 31 December 2022. Venous thrombosis AEs were identified based on the MedDRA Version 25.1 preferred terms (sub-set of preferred terms within the MedDRA SMQ “embolic and thrombotic events venous” [narrow]) representing visceral and peripheral DVT and PE events and preferred terms representing retinal and ophthalmic vein thrombosis events. bIn the analysis of venous thrombosis events, for patients with multiple, contemporaneous venous thrombosis AEs (i.e. simultaneous DVT and PE) the concurrent events are counted as a single, distinct venous thrombosis event. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | Data on File. Guselkumab. Health Authority Response. Janssen Research & Development, LLC. EDMS-RIM-990163; 2023. |