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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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Occurrence of Uveitis in Adult Patients with Plaque Psoriasis or Psoriatic Arthritis

Last Updated: 01/04/2025

SUMMARY

Please refer to the local labeling for relevant information regarding TREMFYA and the occurrence of uveitis.
An integrated pooled safety analysis evaluated the incidence rates of uveitis from 11 phase 2 and 3 clinical trials in patients with moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).¹
- During the placebo-controlled period, adverse events (AEs) of uveitis were not reported in the TREMFYA group. Through the end of the reporting period, the exposure-adjusted incidence rate of uveitis was 0.05 per 100 PYs in the pooled PsO and PsA TREMFYA-treated group (n=4399).

CLINICAL DATA

Pooled Safety Analysis from 11 Phase 2/3 Studies

Strober et al (2023)¹ evaluated the safety of TREMFYA in an integrated pooled analysis of data from 11 randomized, phase 2 and 3 plaque PsO and PsA 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, 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 Uveitis

During the placebo-controlled period, no AEs of uveitis occurred in TREMFYA-treated patients and 1 patient in the placebo group experienced iridocyclitis in both eyes.
The exposure-adjusted incidence rates of uveitis per 100 PYs during the placebo-controlled period are presented in Table: Exposure Adjusted Incidence Rates of Uveitis Per 100 Patient-Years of Follow-up During the Placebo-Controlled Period.

Exposure Adjusted Incidence Rates of Uveitis Per 100 Patient-Years of Follow-up During the Placebo-Controlled Period¹^,a

Events/ 100 PY (95% CI)	PsO (Weeks 0-16)		PsA (Weeks 0-24)			Pooled PsO and PsA
Events/ 100 PY (95% CI)	Placebo^b (n=544)	TREMFYA Q8W^c (n=1220)	Placebo^b (n=517)	TREMFYA Q8W (n=664)	TREMFYA Q4W (n=373)	Placebo^b (n=1061)	Combined TREMFYA (n=2257)
Uveitis^d	0 (0-1.82)	0 (0-0.79)	0.44 (0.01-2.43)	0 (0-0.98)	0 (0-1.74)	0.25 (0.01-1.41)	0 (0-0.35)
Abbreviations: CI, confidence interval; PsA, psoriatic arthritis; PsO, psoriasis; PY, patient-year; Q4W, every 4 weeks; Q8W, every 8 weeks; Q12W, every 12 weeks. ^aIncludes patients in all treatment groups who discontinued study treatment early with the last study treatment (placebo or TREMFYA) administered prior to week 16 or 24 and who did not receive any study agent (placebo or TREMFYA) at or after week 16 or 24; all data, including the final safety follow-up visit, collected through up to 2 years were included in this period. ^bIncludes data prior to TREMFYA exposure in placebo patients who switched from placebo to TREMFYA. ^cAll patients received TREMFYA 100 mg Q8W, except in X-PLORE (n=250 randomized to TREMFYA 5 mg at week 0, week 4, and then Q12W; 15 mg Q8W; 50 mg at week 0, week 4, and then Q12W; 100 mg Q8W; or 200 mg at week 0, week 4, and then Q12W; or placebo with crossover to TREMFYA 100 mg Q8W at week 16) and the Japan registration study (n=65 randomized to TREMFYA 50 mg Q8W and n=26 randomized to placebo with crossover to TREMFYA 50 mg Q8W). ^dPatient-level analysis.

Through the end of the reporting period, AEs of uveitis were reported in 5 TREMFYA-treated patients, which included 4 patients in PsO studies (uveitis, n=3; iritis, n=1) and 1 patient in PsA studies (iridocyclitis, n=1).
The exposure-adjusted incidence rates of uveitis per 100 PYs through the end of the reporting period are presented in Table: Exposure-Adjusted Incidence Rates of Uveitis Per 100 Patient-Years of Follow-up through the End of the Reporting Period.

Exposure-Adjusted Incidence Rates of Uveitis Per 100 Patient-Years of Follow-up through the End of the Reporting Period¹

Events/ 100 PY (95% CI)	PsO	PsA			Pooled PsO and PsA
Events/ 100 PY (95% CI)	All TREMFYA Q8W^a,b(n=2891)	All TREMFYA Q8W (n=783)	All TREMFYA Q4W (n=725)	Combined TREMFYA Q4W+Q8W^c (n=1508)	All TREMFYA (n=4399)
Uveitis^d	0.05 (0.01-0.12)	0.10 (0-0.55)	0 (0-0.27)	0.05 (0-0.26)	0.05 (0.02-0.11)
Abbreviations: CI, confidence interval; PsA, psoriatic arthritis; PsO, psoriasis; PY, patient-years; Q4W, every 4 weeks; Q8W, every 8 weeks; Q12W, every 12 weeks. ^aIncludes patients with PsO originally randomized to placebo or adalimumab at baseline who crossed over to TREMFYA. ^bAll patients received TREMFYA 100 mg Q8W, except in X-PLORE (n=250 randomized to TREMFYA 5 mg at week 0, week 4, and then Q12W; 15 mg Q8W; 50 mg at week 0, week 4, and then Q12W; 100 mg Q8W; or 200 mg at week 0, week 4, and then Q12W; or placebo with crossover to TREMFYA 100 mg Q8W at week 16) and the Japan registration study (n=65 randomized to TREMFYA 50 mg Q8W and n=26 randomized to placebo with crossover to TREMFYA 50 mg Q8W). ^cIncludes patients with PsA randomized to placebo who crossed over to TREMFYA at week 24. ^dPatient-level analysis.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 22 August 2024.

References

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Strober B, Coates LC, Lebwohl MG, et al. Long-term safety of guselkumab in patients with psoriatic disease: an integrated analysis of eleven phase 2/3 clinical studies in psoriasis and psoriatic arthritis. [published online ahead of print October 31, 2023]. Drug Saf. 2023. doi:10.1007/s40264-023-01361-w.