TREMFYA®

(guselkumab)

Medical inquiries

Connect with my medical science liaison

Chat live

Available Monday - Friday 9AM - 4:30PM ET

Call me now

Available Monday - Friday 9AM - 7:30PM ET

Email your inquiry

Call 1-800-526-7736

Available Monday - Friday 9AM - 8PM ET

Live video

Available Monday - Friday 9AM - 4:30PM ET

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)

Medical Information

+ Save link

TREMFYA - Occurrence of Gastrointestinal Serious Adverse Events

Last Updated: 12/09/2024

SUMMARY

Please refer to the local labeling for additional information on TREMFYA and gastrointestinal (GI) serious adverse events (SAE).
A long-term pooled safety analysis of VOYAGE 1 and VOYAGE 2 clinical trials through 4 years (week 204) evaluated the incidence rates of GI-related SAEs in patients with moderate to severe plaque psoriasis (PsO).¹
- Through 4 years, GI-related SAEs were reported in 0.48, 0.35, 0.45, patients per 100 patient-years (PY) in the TREMFYA, adalimumab→TREMFYA and all TREMFYA groups, respectively.
- During years 1, 2, 3, and 4, GI-related SAEs were reported in 0.36, 0.57, 0.41, and 0.46 TREMFYA-treated patients per 100 PY, respectively.
- No cases of inflammatory bowel disease (IBD) were reported as either an adverse event (AE) or SAE in TREMFYA-treated patients through 4 years.
In a long-term pooled safety analysis of VOYAGE 1 and VOYAGE 2 through 5 years (week 264), no cases of IBD were reported in TREMFYA-treated patients (n=1221).²
In the ECLIPSE study, a head-to-head study of TREMFYA and secukinumab in adult patients with moderate to severe PsO, no cases of Crohn’s disease were reported in TREMFYA-treated patients (n=534) through week 56.³
In 2 randomized, double-blind, placebo-controlled, phase 3 studies, DISCOVER-1 and DISCOVER-2, which evaluated the safety and efficacy of TREMFYA in adult patients with active psoriatic arthritis (PsA), through week 24, a GI-related SAE (ileus) was reported in 1 TREMFYA-treated patient in the DISCOVER-1 clinical trial and there were no reports of GI-related SAEs in TREMFYA-treated patients in the DISCOVER-2 clinical trial through week 24.⁴^,⁵
- In a 24-week integrated safety analysis through the placebo-controlled periods and in a pooled safety analysis through 1 year of the DISCOVER-1 and DISCOVER-2 studies, there were no safety signals for IBD and no cases of IBD in TREMFYA-treated patients.⁶^,⁷
In the DISCOVER-2 study, no cases of IBD occurred in TREMFYA-treated patients (n=731); however, one was suspected in a patient receiving placebo through 2 years (week 112).⁸
A pooled safety analysis evaluated the incidence rates of IBD in 11 randomized, doubleblind, phase 2 and 3 studies in patients with plaque PsO and active PsA⁹:
- During the placebo-controlled period, the incidence rate (95% confidence interval [CI]) of IBD was 0.12 (0.00-0.65) per 100 PY in the combined-TREMFYA group (N=2257).
- Through the end of the reporting period, the incidence rate (95% CI) of IBD was 0.01 (0.00-0.05) per 100 PY in the all-TREMFYA group (N=4399).

CLINICAL DATA – moderate to severe plaque psoriasis

VOYAGE 1 and VOYAGE 2: Pooled Safety Analyses

Foley et al (2021)¹ described the GI-related SAEs of TREMFYA for the treatment of moderate to severe plaque PsO in a pooled safety analysis of VOYAGE 1 and VOYAGE 2 through 4 years (week 204).

Study Design/Methods

In VOYAGE 1 and VOYAGE 2, patients were randomized to:¹^,¹⁰
- TREMFYA 100 mg by subcutaneous (SC) injection at weeks 0, 4, and 12, then every 8 weeks (q8w) (n=329 in VOYAGE 1 and n=496 in VOYAGE 2)
- Placebo at weeks 0, 4, and 12, followed by TREMFYA 100 mg SC at weeks 16 and 20, then q8w (n=174 in VOYAGE 1 and n=248 in VOYAGE 2)
- Adalimumab 80 mg SC at week 0, 40 mg SC at week 1, then 40 mg SC every 2 weeks (q2w) through week 47 (VOYAGE 1) or week 23 (VOYAGE 2) (n=334 in VOYAGE 1 and n=248 in VOYAGE 2)
VOYAGE 1 and VOYAGE 2 were open label after week 48 and week 76, respectively.
Patients with a history or current signs of severe, progressive, or uncontrolled medical condition were excluded from VOYAGE 1 and VOYAGE 2.¹
Patients with GI symptoms or a previous history of IBD were not excluded from VOYAGE 1 and VOYAGE 2.
Events of IBD were defined as the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) of Crohn’s disease (CD) and ulcerative colitis (UC) within the system organ class (SOC) of GI disorders. All MedDRA PTs within the GI SOC that met the seriousness criteria of the International Council on Harmonization guidance document related to Good Clinical Practices were identified as GI SAEs. Nonserious AEs were reviewed to see if any could be considered IBD.
Durations of exposure evaluated using pooled safety data from the VOYAGE 1 and VOYAGE 2 clinical trials through week 204 were non-contemporaneous across treatment groups (ie, year 1-4 for TREMFYA, year 1.3-4 [weeks 16-204] for placebo→TREMFYA, year 2-4 for adalimumab→TREMFYA in VOYAGE 1 and variable times to crossover from placebo or adalimumab to TREMFYA in VOYAGE 2).

Results

Baseline Demographics

Medical history of patients enrolled in VOYAGE 1 and VOYAGE 2 included conditions typically observed in patients with PsO.¹
The incidence of pre-existing IBD is unknown, as these specific data were not collected at baseline.
Baseline demographics of the pooled VOYAGE 1 and VOYAGE 2 patient population are shown in table: Pooled VOYAGE 1 and VOYAGE 2 Baseline Demographics.

Pooled VOYAGE 1 and VOYAGE 2 Baseline Demographics¹

	TREMFYA^a (n=1221)	Adalimumab→TREMFYA^b (n=500)	All TREMFYA (n=1721)
Age, years	43.8±12.45	43.0±12.22	43.5±12.38
Female	359 (29.4)	140 (28.0)	499 (29.0)
White	1000 (81.9)	412 (82.4)	1412 (82.1)
Weight (kg)	88.9±20.97	88.5±21.50	88.8±21.12
% BSA	28.0±16.56	28.3±16.00	28.1±16.40
PASI (0-72)	21.7±8.86	21.7±8.50	21.7±8.76
IGA score (0-4) Mild (2) Moderate (3) Severe (4)	0 937 (76.7) 284 (23.3)	2 (0.4) 379 (75.8) 119 (23.8)	2 (0.1) 1316 (76.5) 403 (23.4)
Duration of psoriasis, years	17.9±12.05	17.4±11.57	17.8±11.91
Data are presented as n (%) or mean ± standard deviation. Abbreviations: BSA, body surface area; IGA, investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index. ^aIncludes patients randomized to TREMFYA at baseline and those randomized to placebo who crossed over to receive TREMFYA at week 16. ^bIncludes patients randomized to adalimumab at baseline who crossed over to receive TREMFYA at week 52 in VOYAGE 1 and at or after week 28 in VOYAGE 2.

The duration of exposure to TREMFYA through week 204 is described in table: Duration of Exposure to TREMFYA by Treatment Group through 4 Years.

Duration of Exposure to TREMFYA by Treatment Group through 4 Years¹

	TREMFYA^a (n=1221)	Adalimumab→TREMFYA^b (n=500)	All TREMFYA (n=1721)
At least 6 months^c	1174 (96.2)	488 (97.6)	1662 (96.6)
At least 1 year^d	1131 (92.6)	481 (96.2)	1612 (93.7)
At least 2 years^e	1082 (88.6)	463 (92.6)	1545 (89.8)
At least 3 years^f	1034 (84.7)	420 (84.0)	1454 (84.5)
At least 4 years^g	661 (54.1)	0	661 (38.4)
Data are presented as n (%). ^aIncludes patients randomized to TREMFYA at baseline and those randomized to placebo who crossed over to receive TREMFYA at week 16. ^bIncludes patients randomized to adalimumab at baseline who crossed over to receive TREMFYA at week 52 in VOYAGE 1 and at or after week 28 in VOYAGE 2. ^cThe duration between the first and last TREMFYA administration was at least 16 weeks. ^dThe duration between the first and last TREMFYA administration was at least 40 weeks. ^eThe duration between the first and last TREMFYA administration was at least 88 weeks. ^fThe duration between the first and last TREMFYA administration was at least 136 weeks. ^gThe duration between the first and last TREMFYA administration was at least 184 weeks.

The average number of TREMFYA injections through week 204 was 21.5, 18.7 and 20.7 for the TREMFYA, Adalimumab→TREMFYA, and all TREMFYA arms respectively.
The mean total dose of TREMFYA ± standard deviation (SD) received by patients in the TREMFYA, Adalimumab→TREMFYA and all TREMFYA groups were 2151.1±665.02, 1873.6±413.58, and 2071.2±615.88, respectively.
Cumulative rates of GI-related SAEs per 100 PY of follow-up through year 4 are shown in table: Rates of GI-Related SAEs (Number of Patients per 100 PYs) by Treatment Group through 4 Years

Rates of GI-Related SAEs (Number of Patients per 100 PYs) by Treatment Group through 4 Years¹

	TREMFYA^a (n=1221)	Adalimumab→TREMFYA^b (n=500)	All TREMFYA (n=1721)
GI-related SAEs	0.48	0.35	0.45
Abbreviations: GI, gastrointestinal; SAE, serious adverse event. ^aIncludes patients randomized to TREMFYA at baseline and those randomized to placebo who crossed over to receive TREMFYA at week 16. ^bIncludes patients randomized to adalimumab at baseline who crossed over to receive TREMFYA at week 52 in VOYAGE 1 and at or after week 28 in VOYAGE 2.

No pattern changes or increasing rates of SAEs with longer duration of exposure were observed in all TREMFYA treated patients (Table: Rates of GI-Related SAEs [Number of Patients per 100 PYs) by Exposure Period).

Rates of GI-Related SAEs (Number of Patients per 100 PYs) by Exposure Period¹^,a

	Year 1 (n=1721)	Year 2 (n=1609)	Year 3 (n=1536)	Year 4 (n=1165)
GI-related SAEs	0.36	0.57	0.41	0.46
Abbreviations: GI, gastrointestinal; SAE, serious adverse event. ^aTotal patient years of follow-up: 1662 (Year 1), 1570 (Year 2), 1464 (Year 3), 867 (Year 4). Median patient-years of follow-up: 1.0 (Year 1), 1.0 (Year 2), 1.0 (Year 3), and 0.9 (Year 4).

No cases of IBD were reported as either an AE or SAE (Table: Number of GI-Related SAEs per 100 PY by Treatment Group through 4 Years).

Number of GI-Related SAEs per 100 Patient-Years by Treatment Group through 4 Years¹

	TREMFYA (n=1221)	Adalimumab→TREMFYA (n=500)	All TREMFYA (n=1721)
Total patient-years of follow-up	4145	1418	5564
Median patient-years of follow-up	3.9	2.9	3.6
Inflammatory bowel disease Crohn’s disease Ulcerative colitis	0 0	0 0	0 0
GI Disorders Hemorrhoids Inguinal hernia Umbilical hernia Gastritis Pancreatitis Pancreatitis acute Abdominal hernia Colitis Duodenal ulcer Enterocutaneous fistula Hemorrhoidal hemorrhage Intestinal strangulation Irritable bowel syndrome Upper GI hemorrhage	0.48 0.07 0.07 0.02 0.05 0.05 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02	0.35 0.07 0.07 0.14 0.00 0.00 0.07 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00	0.45 0.07 0.07 0.05 0.04 0.04 0.04 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02
Data presented as number of SAEs per 100 patient-years, unless otherwise noted. Abbreviations: GI, gastrointestinal; SAE, serious adverse event. ^aIncludes patients randomized to TREMFYA at baseline and those randomized to placebo who crossed over to receive TREMFYA at week 16. ^bIncludes patients randomized to adalimumab at baseline who crossed over to receive TREMFYA at week 52 in VOYAGE 1 and at or after week 28 in VOYAGE 2.

Blauvelt et al (2021)² conducted a pooled safety analysis VOYAGE 1 and VOYAGE 2 studies (N=1829 at baseline) through 5 years (week 264).

No cases of IBD were reported in TREMFYA-treated patients (n=1221) through 5 years.

ECLIPSE

Reich et al (2019)³ reported efficacy and safety results, including the occurrence of Crohn’s disease, from ECLIPSE, a head-to-head study of TREMFYA and secukinumab in adult patients with moderate to severe PsO.

Study Design/Methods

Eligible patients (n=1048) were randomized at week 0 in a 1:1 ratio to TREMFYA 100 mg SC at week 0, 4, 12, and q8w thereafter or secukinumab 300 mg SC at weeks 0, 1, 2, 3, 4, and every 4 weeks (q4w) thereafter through week 44.
Safety was assessed through week 56.

Results

Select baseline demographics of ECLIPSE population are shown in table: ECLIPSE Baseline Demographics.

ECLIPSE Baseline Demographics³

	TREMFYA (n=534)	Secukinumab (n=514)
Age, years	46.3±13.7	45.3±13.6
Male	365 (68)	342 (67)
White	499 (93)	480 (93)
Body mass index (kg/m²)	29.8±7.1	30.0±6.3
% BSA	23.7±12.9	24.5±14.6
PASI (0-72)	20.0±7.4	20.1±7.6
IGA score (0-4) Cleared (0) Minimal (1) Mild (2) Moderate (3) Severe (4)	0 0 0 407 (76) 127 (24)	0 0 1 (<1) 391 (76) 122 (24)
Duration of psoriasis, years	18.5±12.2	18.3±12.7
Data are presented as n (%) or mean ± standard deviation. Abbreviations: BSA, body surface area; IGA, investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index.

No cases of CD were reported in TREMFYA-treated patients (n=534) through week 56.

clinical data – active psoriatic arthritis

DISCOVER-1 and DISCOVER-2

Deodhar et al (2020)⁴ and Mease et al (2020)⁵ reported results from 2 randomized, double-blind, placebo controlled, phase 3 studies (DISCOVER-1 and DISCOVER-2) that evaluated the efficacy and safety of TREMFYA compared to placebo in adult patients with active PsA. Rahman et al (2020)⁶ and Ritchlin et al (2020)⁷ assessed the safety of TREMFYA using safety results through week 24 and 1 year, respectively, from the DISCOVER-1 and DISCOVER-2 studies.

In DISCOVER-1, approximately 31% of patients were previously treated with up to
2 anti-tumor necrosis factor alpha (anti-TNFα) agents whereas in DISCOVER-2, all patients were biologic-naïve.⁴^,⁵
In DISCOVER-1 and DISCOVER-2, patients were randomized 1:1:1 to receive:
- TREMFYA 100 mg by SC injection at weeks 0 and 4, then q8w (n=127 in DISCOVER-1 and n=248 in DISCOVER-2)
- TREMFYA 100 mg by SC injection at week 0, then q4w (n=128 in DISCOVER-1 and n=245 in DISCOVER-2) or
- Placebo at week 0, then q4w (n=126 in DISCOVER-1 and n=246 in DISCOVER-2)
Patients with a history or current signs or symptoms of severe, progressive, or uncontrolled GI disturbances were excluded from DISCOVER-1 and DISCOVER-2.¹¹^,¹²
AEs and clinical laboratory test results were assessed in an integrated safety analysis through week 24 (placebo-controlled phase) in both studies, and in a pooled safety analysis through week 60 in DISCOVER-1 (end of the study) and through week 52 in DISCOVER-2 (ongoing study).⁶^,⁷

Results

Through week 24, a GI-related SAE (ileus) was reported in 1 patient in the TREMFYA 100 mg q8w group from the DISCOVER-1 clinical trial and there were no reports of GI-related SAEs in TREMFYA-treated patients in the DISCOVER-2 clinical trial.⁴^,⁵
In a 24-week integrated safety analysis through the placebo-controlled periods and in a pooled safety analysis through 1 year of the DISCOVER-1 and DISCOVER-2 studies, there were no safety signals for IBD and no cases of IBD in TREMFYA-treated patients.⁶^,⁷

DISCOVER-2

McInnes et al (2021)⁸ evaluated the long-term efficacy (through week 100) and safety (through week 112) of TREMFYA in patients with PsA through 2 years.

No cases of IBD occurred in TREMFYA-treated patients (n=731) however, one was suspected in a patient receiving placebo through 2 years.

Clinical Data – Plaque psoriasis and psoriatic arthritis

Pooled Safety Analysis

Strober et al (2022)⁹ evaluated the safety of TREMFYA in a pooled analysis of data from 11 randomized, double-blind, phase 2 and 3 plaque PsO and active PsA studies.

Study Design/Methods

The safety data were summarized for the placebo-controlled period for placebo- and TREMFYA-treated patients and through the end of the reporting period for TREMFYAtreated patients.
The safety reporting periods for the studies are shown in Table: Safety Reporting Period for Clinical Studies Included in the Pooled Analysis.

Safety Reporting Period for Clinical Studies Included in the Pooled Analysis⁹

Safety Reporting Period	Moderate to Severe Plaque PsO^{a, b}(N=2891; Total 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; Total 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-years. ^aAll studies included a placebo-controlled period (weeks 0-16), except NAVIGATE (active comparator: ustekinumab) and ECLIPSE (active comparator: secukinumab). ^bData summarized for safety reporting periods of up to 5 years, including patients originally randomized to adalimumab (VOYAGE 1 and VOYAGE 2) or placebo (X-PLORE, VOYAGE-1, VOYAGE-2, ORION, and Japan registration) at baseline who crossed over to TREMFYA. ^cAll studies included a placebo-controlled period (weeks 0-24). ^dData summarized for safety reporting periods of up to 2 years, including patients originally randomized to placebo at baseline who crossed over to TREMFYA starting at week 24.

Results

The exposure-adjusted incidence rates of IBD during the placebo-controlled period are presented in Table: Pooled Exposure-Adjusted Incidence Rates of IBD During the Placebo-Controlled Period.

Pooled Exposure-Adjusted Incidence Rates of IBD During the Placebo-Controlled Period⁹^,¹³

Events/ 100 PY (95% CI)	PsO (W0-16)
Events/ 100 PY (95% CI)	PBO^b (N=544)	TREMFYA^c q8w (N=1220)	PBO^b (N=517)	TREMFYA q8w (N=664)	TREMFYA q4w (N=373)	PBO^b (N=1061)	Comb TREMFYA (N=2257)
IBD^d	0.00 (0.00-1.82)	0.00 (0.00-0.79)	0.44 (0.01-2.43)	0.33 (0.01-1.83)	0.00 (0.00-1.74)	0.25 (0.01-1.41)	0.12 (0.00-0.65)
CD/UC	0.00 (0.00-1.82)	0.00 (0.00-0.79)	0.00 (0.00-1.30)	0.00 (0.00-0.98)	0.00 (0.00-1.74)	0.00 (0.00-0.76)	0.00 (0.00-0.35)
Abbreviations: CD, Crohn’s disease; CI, confidence interval; comb, combined; IBD, inflammatory bowel disease; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis; PY, patient-years; q12w, every 12 weeks; q4w, every 4 weeks; q8w, every 8 weeks; UC, ulcerative colitis; W, week. ^aIncludes patients in all treatment groups who discontinued study treatment early with the last study agent (PBO or TREMFYA) that was administered prior to W16 or W24 and who did not receive any study agent (PBO or TREMFYA) at or after W16 or W24; 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 PBO-randomized patients who switched from PBO to TREMFYA. ^cAll patients received TREMFYA 100 mg q8w, except for those in X-PLORE (patients [n=250] randomized to receive TREMFYA 5 mg at W0, W4, and then q12w; TREMFYA 15 mg q8w; TREMFYA 50 mg at W0, W4, and then q12w; TREMFYA 100 mg q8w; TREMFYA 200 mg at W0, W4, and then q12w; or PBO with crossover to TREMFYA 100 mg q8w at W16) and the Japan registration study (patients randomized to receive TREMFYA 50 mg q8w [n=65] or PBO [n=26] with crossover to TREMFYA 50 mg q8w). ^dOne case of suspected IBD was reported in a patient who received PBO in DISCOVER-2, and 1 case of suspected IBD was reported in a patient who received 3 doses of TREMFYA q8w in COSMOS (celiac disease was also suspected in this patient); neither diagnoses (IBD nor celiac disease) were confirmed, and the patient was lost to follow-up.

The exposure-adjusted incidence rates of IBD through the end of the reporting period are presented in Table: Pooled Exposure-Adjusted Incidence Rates of IBD through the End of the Reporting Period.

Pooled Exposure-Adjusted Incidence Rates of IBD through the End of the Reporting Period⁹^,¹³

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)	Comb TREMFYA q4w+q8w^c (N=1508)	All TREMFYA (N=4399)
IBD^d	0.00 (0.00-0.03)	0.10 (0.00-0.55)	0.00 (0.00-0.27)	0.05 (0.00-0.26)	0.01 (0.00-0.05)
CD/UC	0.00 (0.00-0.03)	0.00 (0.00-0.29)	0.00 (0.00-0.27)	0.00 (0.00-0.14)	0.00 (0.00-0.03)
Abbreviations: CD, Crohn’s disease; CI, confidence interval; comb, combined; IBD, inflammatory bowel disease; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis; PY, patient-years; q12w, every 12 weeks; q4w, every 4 weeks; q8w, every 8 weeks; UC, ulcerative colitis; W, week. ^aIncludes patients with PsO originally randomized to receive PBO or adalimumab at baseline and who crossed over to TREMFYA. ^bAll patients received TREMFYA 100 mg q8w, except for those in X-PLORE (patients [n=250] randomized to receive TREMFYA 5 mg at W0, W4, and then q12w; TREMFYA 15 mg q8w; TREMFYA 50 mg at W0, W4, and then q12w; TREMFYA 100 mg q8w; TREMFYA 200 mg at W0, W4, and then q12w; or PBO with crossover to TREMFYA 100 mg q8w at W16) and the Japan registration study (patients randomized to receive TREMFYA 50 mg q8w [n=65] or PBO [n=26] with crossover to TREMFYA 50 mg q8w). ^cIncludes patients with PsA randomized to receive PBO who crossed over to TREMFYA at W24. ^dOne case of suspected IBD was reported in a patient who received 3 doses of TREMFYA q8w in COSMOS (celiac disease was also suspected in this patient); neither diagnoses (IBD nor celiac disease) were confirmed, and the patient was lost to follow-up.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 05 December 2024.

Data included in this response are from the following phase 3 clinical trials of TREMFYA in patients with plaque PsO or PsA (VOYAGE 1, VOYAGE 2, ECLIPSE, DISCOVER 1, DISCOVER 2). Additional information from pooled safety analyses across PsO and/or PsA published literature are also included.

References

Show

1	Foley P, Reich K, Blauvelt A, et al. Serious gastrointestinal-related adverse events among psoriasis patients treated with guselkumab in VOYAGE 1 and VOYAGE 2. J Drugs Dermatol. 2021;20(8):855-860.
2	Blauvelt A, Tsai TF, Langley RG, et al. Consistent safety profile with up to 5 years of continuous treatment with guselkumab: pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis. J Am Acad Dermatol. 2022;86(4):827-834.
3	Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831-839.
4	Deodhar A, Helliwell P, Boehncke W, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125.
5	Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial [published correction appears in Lancet. 2020;395(10230):1114]. Lancet. 2020;395(10230):1126-1136.
6	Rahman P, Ritchlin C, Helliwell P, et al. Integrated safety results of two phase-3 trials of guselkumab in patients with psoriatic arthritis, through the placebo-controlled periods. Poster presented at: European League Against Rheumatism (EULAR); June 3-6, 2020; E-Congress.
7	Ritchlin C, Rahman P, Helliwell P, et al. Pooled safety results from two phase-3 trials of guselkumab in patients with psoriatic arthritis through 1 year. presented at: Poster presented at: American College of Rheumatology (ACR); November 5-9, 2020; E-congress.
8	McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naive patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485.
9	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.
10	Reich K, Gordon KB, Strober BE, et al. Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021;185(6):1146-1159.
11	Deodhar A, Helliwell PS, Boehncke WH, et al. Supplement to: Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125.
12	Mease PJ, Rahman P, Gottlieb AB, et al. Supplement to: Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial [published correction appears in Lancet. 2020 Apr 4;395(10230):1114]. Lancet. 2020;395(10230):1126-1136.
13	Strober B, Coates L, Yu J, et al. Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 phase 2/3 clinical studies in psoriasis and psoriatic arthritis. Poster presented at: American College of Rheumatology (ACR) Convergence; November 10-14, 2022; Philadelphia, PA.