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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

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TREMFYA – Occurrence of Injection Site Reactions in Adult Patients with Plaque Psoriasis or Psoriatic Arthritis

Last Updated: 01/10/2025

SUMMARY

Please refer to the local labeling for relevant information regarding TREMFYA and the occurrence of injection site reactions.
An integrated pooled safety analysis evaluated the incidence rates of injection site reactions (ISRs) from 11 phase 2 and 3 clinical trials in adult patients with moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).¹
- The median duration of TREMFYA exposure was 1.7 years, 3.5 years, and 1.2 years in the pooled population, PsO group, and PsA group, respectively.
- In the pooled PsO and PsA studies, ISRs occurred in 5.3% (153/2891) and 2% (30/1508) of patients receiving TREMFYA, respectively.

CLINICAL DATA

Pooled Safety Analysis

Strober et al (2024)¹ evaluated the safety of TREMFYA in adult patients with psoriatic disease in an integrated pooled analysis of data from 11 randomized (7 plaque PsO; 4 active PsA), phase 2 and 3 studies.

Study Design/Methods

All plaque PsO studies (X-PLORE, VOYAGE 1, VOYAGE 2, ORION, Japan Registration) included a placebo-controlled period (weeks 0-16), except NAVIGATE (active comparator: ustekinumab) and ECLIPSE (active comparator: secukinumab).
All active PsA studies (Phase 2, DISCOVER-1, DISCOVER-2, and COSMOS) included a placebo-controlled period (weeks 0-24).
This long-term safety analysis included a total of 4399 patients (PsO, n=2891; PsA, n=1508) who received ≥1 administration of TREMFYA for a total follow-up of 10,787 patient-years (PYs); see Table: Safety Reporting Period for Clinical Studies Included in the Integrated Analysis.
The median duration of TREMFYA exposure was 1.7 years, 3.5 years, and 1.2 years in the pooled population, PsO group, and PsA group, respectively.

Safety Reporting Period for Clinical Studies Included in the Integrated Analysis¹

Safety Reporting Period	Moderate to Severe Plaque PsO^{a, b} (N=2891, PY=8662)
Safety Reporting Period	VOYAGE 1 and VOYAGE 2	NAVIGATE		ORION		ECLIPSE	Japan Registration		X-PLORE (Phase 2)
Weeks	0-264	16-60		0-40		0-56	0-156		0-52
Safety Reporting Period	Active PsA^{c, d}(N=1508, PY=2125)
Safety Reporting Period	DISCOVER-1		DISCOVER-2		COSMOS			Phase 2
Weeks	0-60		0-112		0-56			0-56
Abbreviations: PsA, psoriatic arthritis; PsO, psoriasis; PY, patient-year. ^aAll studies included a placebo-controlled period (weeks 0-16), except NAVIGATE and ECLIPSE. ^bData summarized for safety reporting periods of up to 5 years, including patients randomized to placebo, TREMFYA, or adalimumab (VOYAGE 1 and 2 only) at baseline who crossed over to TREMFYA and patients randomized to TREMFYA after receiving open-label ustekinumab (NAVIGATE). ^cAll studies included a placebo-controlled period (weeks 0-24). ^dData summarized for safety reporting periods of up to 2 years, including patients randomized to placebo at baseline who crossed over to TREMFYA at week 24.

Results for Injection Site Reactions

In the pooled plaque PsO studies, ISRs occurred in 5.3% (153/2891) of patients receiving TREMFYA.
- Of the 57,603 injections, 464 (0.8%) were reported with ISRs and most were described as mild.
In the pooled active PsA studies, ISRs occurred in 2% (30/1508) of patients receiving TREMFYA.
- Of the 19,303 injections, 75 (0.4%) were reported with ISRs and most were described as mild.
No events of serum-like sickness or anaphylactic reactions related to TREMFYA were reported.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 21 November 2024.

References

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1	Strober B, Coates LC, Lebwohl MG, et al. Long-term safety of guselkumab in patients with psoriatic disease: an integrated analysis of eleven phase II/III clinical studies in psoriasis and psoriatic arthritis. Drug Saf. 2024;47(1):39-57.