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Adverse Reactions
Safety: Induction
Safety: Maintenance
Safety: Long-term Extension

TREMFYA® is backed by a rigorous clinical program in UC* and 15+ years of combined clinical research1,2†

Approved in 4 indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis (UC)

patients assessed in UC

†Based on a clinical trial of TREMFYA® initiated in 2009.

Adverse Reactions

TREMFYA® PEN SC Induction

SC induction (ASTRO)

Adverse reactions occurring in ≥3% of patients through Week 24 and at a higher rate than placebo1

TREMFYA®*

400 mg→
100 mg SC q8w (N=139)
n (%)

TREMFYA®†

400 mg→
200 mg
SC q4w (N=140)
n (%)

Placebo

(N=139)
n (%)

Arthralgia11 (7.9%)7 (5.0%)3 (2.2%)
Upper respiratory
tract infections‡		11 (7.9%)5 (3.6%)9 (6.5%)
Injection site reactions§7 (5.0%)9 (6.4%)4 (2.9%)
Headache||8 (5.8%)7 (5.0%)3 (2.2%)
Gastroenteritis4 (2.9%)3 (2.1%)0
Fatigue2 (1.4%)4 (2.9%)1 (0.7%)
Pyrexia1 (0.7%)4 (2.9%)2 (1.4%)
Rash4 (2.9%)1 (0.7%)1 (0.7%)
TREMFYA® IV Induction

IV induction (QUASAR)

  • Adverse reactions that occurred in ≥2% of patients in the TREMFYA® 200 mg IV induction group at a higher rate than placebo in the induction studies were respiratory tract infections (8.8% vs 7.3%)1

Adverse reactions occurring in ≥3% of patients through Week 44 and at a higher rate than placebo1

TREMFYA®#

100 mg
SC q8w
(N=186)
n (%)

TREMFYA®#

200 mg
SC q4w
(N=190)
n (%)

Placebo

(N=192)
n (%)

Injection site reactions**2 (1.1%)17 (8.9%)††2 (1%)
Arthralgia8 (4.3%)15 (7.9%)13 (6.8%)
Upper
respiratory
tract infection		6 (3.2%)13 (6.8%)8 (4.2%)

Adverse reactions occurring in ≥3% of patients through Week 24 and at a higher rate than placebo

TREMFYA®*

400 mg→
100 mg SC q8w (N=139)
n (%)

TREMFYA®†

400 mg→
200 mg
SC q4w (N=140)
n (%)

Placebo

(N=139)
n (%)

Arthralgia11 (7.9%)7 (5.0%)3 (2.2%)
Upper respiratory
tract infections‡		11 (7.9%)5 (3.6%)9 (6.5%)
Injection site reactions§7 (5.0%)9 (6.4%)4 (2.9%)
Headache||8 (5.8%)7 (5.0%)3 (2.2%)
Gastroenteritis4 (2.9%)3 (2.1%)0
Fatigue2 (1.4%)4 (2.9%)1 (0.7%)
Pyrexia1 (0.7%)4 (2.9%)2 (1.4%)
Rash4 (2.9%)1 (0.7%)1 (0.7%)

*TREMFYA® 400 mg as a subcutaneous injection at Weeks 0, 4, and 8, followed by TREMFYA® 100 mg as an SC injection at Week 16 and every 8 weeks thereafter.

†TREMFYA® 400 mg as a subcutaneous injection at Weeks 0, 4, and 8, followed by TREMFYA® 200 mg as an SC injection at Week 12 and every 4 weeks thereafter.

‡Upper respiratory tract infections include upper respiratory tract infection and viral upper respiratory tract infection.

§Injection site reactions include injection site erythema, injection site swelling, injection site pain, injection site paresthesia, injection site edema, injection site bruising, injection site induration, injection site pruritus, application site edema, application site erythema, and application site pain.

||Headache includes headache, migraine, and sinus headache.

Rash includes rash and rash pruritic.

IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

  • Adverse reactions that occurred in ≥2% of patients in the TREMFYA® 200 mg IV induction group at a higher rate than placebo in the induction studies were respiratory tract infections (8.8% vs 7.3%)1

Adverse reactions occurring in ≥3% of patients through Week 44 and at a higher rate than placebo1

TREMFYA®#

100 mg
SC q8w
(N=186)
n (%)

TREMFYA®#

200 mg
SC q4w
(N=190)
n (%)

Placebo

(N=192)
n (%)

Injection site reactions**2 (1.1%)17 (8.9%)††2 (1%)
Arthralgia8 (4.3%)15 (7.9%)13 (6.8%)
Upper
respiratory
tract infection		6 (3.2%)13 (6.8%)8 (4.2%)

†Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.1

‡Injection site reactions include administration site pain, injection site hematoma, injection site hemorrhage, injection site hypersensitivity, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, and injection site urticaria.1

§TREMFYA® 200 mg was administered as two 100-mg injections.1

IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

*TREMFYA® 400 mg as a subcutaneous injection at Weeks 0, 4, and 8, followed by TREMFYA® 100 mg as an SC injection at Week 16 and every 8 weeks thereafter.

†TREMFYA® 400 mg as a subcutaneous injection at Weeks 0, 4, and 8, followed by TREMFYA® 200 mg as an SC injection at Week 12 and every 4 weeks thereafter.

‡Upper respiratory tract infections include upper respiratory tract infection and viral upper respiratory tract infection.

§Injection site reactions include injection site erythema, injection site swelling, injection site pain, injection site paresthesia, injection site edema, injection site bruising, injection site induration, injection site pruritus, application site edema, application site erythema, and application site pain.

||Headache includes headache, migraine, and sinus headache.

Rash includes rash and rash pruritic.

#Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.1

**Injection site reactions include administration site pain, injection site hematoma, injection site hemorrhage, injection site hypersensitivity, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, and injection site urticaria.

††TREMFYA® 200 mg was administered as two 100-mg injections.1

IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

Adverse Events (Induction)

Safety during induction: Treatment-Emergent adverse events through Week 122,3

TREMFYA®*

400 mg SC
(N=279)

Placebo

(N=139)

TREMFYA®*

200 mg IV
q4w
(N=421)

Placebo*

(N=280)

Treatment-emergent AEsn (%)n (%)n (%)n (%)
Any AE110 (39.4)73 (52.5)208 (49.4)135 (49.3)
Serious AE7 (2.5)11 (7.9)12 (2.9)20 (7.1)
AE leading to discontinuation of study agent3 (1.1)8 (5.8)7 (1.7)11 (3.9)
Infection†42 (15.1)28 (20.1)66 (15.7)43 (15.4)
Serious infection†3 (1.1)03 (0.7)1 (0.4)
Deaths01 (0.7)1 (0.2)2 (0.7)
AE of interestn (%)n (%)n (%)n (%)
Malignancy (excluding NMSC)1 (0.4)000
NMSC002 (0.5)0
Opportunistic infection1 (0.4)001 (0.4)†
Tuberculosis0000
Hepatic disorders that were serious 
or led to treatment discontinuation		0000

*Randomized patients in the induction study who received at least 1 dose of study intervention.

†Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.

AE=adverse event; IV=intravenous; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; UC=ulcerative colitis.

TREMFYA®*

400 mg SC
(N=279)

Placebo

(N=139)

TREMFYA®*

200 mg IV
q4w
(N=421)

Placebo*

(N=280)

Treatment-emergent AEsn (%)n (%)n (%)n (%)
Any AE110 (39.4)73 (52.5)208 (49.4)135 (49.3)
Serious AE7 (2.5)11 (7.9)12 (2.9)20 (7.1)
AE leading to discontinuation of study agent3 (1.1)8 (5.8)7 (1.7)11 (3.9)
Infection†42 (15.1)28 (20.1)66 (15.7)43 (15.4)
Serious infection†3 (1.1)03 (0.7)1 (0.4)
Deaths01 (0.7)1 (0.2)2 (0.7)
AE of interestn (%)n (%)n (%)n (%)
Malignancy (excluding NMSC)1 (0.4)000
NMSC002 (0.5)0
Opportunistic infection1 (0.4)001 (0.4)†
Tuberculosis0000
Hepatic disorders that were serious 
or led to treatment discontinuation		0000

*Randomized patients in the induction study who received at least 1 dose of study intervention.

†Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.

AE=adverse event; IV=intravenous; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; UC=ulcerative colitis.

SC induction (ASTRO)

IV induction (QUASAR)

TREMFYA®*

400 mg SC
(N=279)

Placebo

(N=139)

TREMFYA®*

200 mg IV
q4w
(N=421)

Placebo*

(N=280)

Treatment-emergent AEsn (%)n (%)n (%)n (%)
Any AE110 (39.4)73 (52.5)208 (49.4)135 (49.3)
Serious AE7 (2.5)11 (7.9)12 (2.9)20 (7.1)
AE leading to discontinuation of study agent3 (1.1)8 (5.8)7 (1.7)11 (3.9)
Infection†42 (15.1)28 (20.1)66 (15.7)43 (15.4)
Serious infection†3 (1.1)03 (0.7)1 (0.4)
Deaths01 (0.7)1 (0.2)2 (0.7)
AE of interestn (%)n (%)n (%)n (%)
Malignancy (excluding NMSC)1 (0.4)000
NMSC002 (0.5)0
Opportunistic infection1 (0.4)001 (0.4)†
Tuberculosis0000
Hepatic disorders that were serious 
or led to treatment discontinuation		0000

*Randomized patients in the induction study who received at least 1 dose of study intervention.

†Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.

AE=adverse event; IV=intravenous; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; UC=ulcerative colitis.

Adverse Events (Maintenance)

Safety during maintenance: Treatment-Emergent adverse events2

ASTRO (SC Induction) Treat-Through Study from Week 12 through Week 48

TREMFYA®

100 mg
SC
q8w
(N=138)

TREMFYA®

200 mg
SC
q4w
(N=140)

Placebo*

(N=136)

TREMFYA®†‡

100 mg SC
q8w
(N=186)

TREMFYA®†‡

200 mg SC
q4w
(N=190)

Placebo‡

(N=192)

Total patient-years of follow-upPY=90.9PY=88.9PY=48.6PY=144.5PY=142.6PY=125.1
Treatment-emergent AEs%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)
Any AE68.1
(263.97)		67.9
(296.92)		44.9
(314.98)		64.5
(245.73)		70.0
(345.61)		68.2
(288.63)
Serious AE2.9 (4.40)5.0 (7.87)8.8 (39.11)2.7 (3.46)6.3 (13.32)0.5 (0.80)
AE leading to discontinuation of 
study agent		4.3
(6.60)		1.4
(2.25)		5.9
(16.47)		3.8
(4.85)		2.6
(3.51)		6.8
(10.39)
Infection§31.2
(81.39)		28.6
(66.36)		19.1
(69.99)		31.7
(59.53)		31.1
(66.60)		32.8
(65.56)
Serious infection§0 (0.00)1.4 (2.25)1.5 (6.18)0.5 (0.69)1.1 (1.40)0 (0.00)
Deaths0.7 (1.10)II0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
AE of
interest		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)
Malignancy (excluding NMSC)0 (0.00)0.7 (1.12)0.7 (2.06)0 (0.00)1 (0.70)1 (1.60)
NMSC0 (0.00)0.7 (1.12)0 (0.00)0 (0.00)0 (0.00)1 (1.60)
Opportunistic infection0.7 (1.10)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
Tuberculosis0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
Hepatic disorders that were serious
or led to treatment discontinuation		0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)

*Includes all placebo subjects excluding data after a subject is rescued with guselkumab.

†Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.

‡Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.

§Reported through Week 48. Intraventricular hemorrhage considered by investigator to not be related to study agent.

AE=adverse events; E=events; IV=intravenous; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; UC=ulcerative colitis.

QUASAR (IV Induction) Randomized Withdrawal Study
Through Week 44

TREMFYA®

100 mg
SC
q8w
(N=138)

TREMFYA®

200 mg
SC
q4w
(N=140)

Placebo*

(N=136)

TREMFYA®†‡

100 mg SC
q8w
(N=186)

TREMFYA®†‡

200 mg SC
q4w
(N=190)

Placebo‡

(N=192)

Total patient-years of follow-upPY=90.9PY=88.9PY=48.6PY=144.5PY=142.6PY=125.1
Treatment-emergent AEs%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)
Any AE68.1
(263.97)		67.9
(296.92)		44.9
(314.98)		64.5
(245.73)		70.0
(345.61)		68.2
(288.63)
Serious AE2.9 (4.40)5.0 (7.87)8.8 (39.11)2.7 (3.46)6.3 (13.32)0.5 (0.80)
AE leading to discontinuation of 
study agent		4.3
(6.60)		1.4
(2.25)		5.9
(16.47)		3.8
(4.85)		2.6
(3.51)		6.8
(10.39)
Infection§31.2
(81.39)		28.6
(66.36)		19.1
(69.99)		31.7
(59.53)		31.1
(66.60)		32.8
(65.56)
Serious infection§0 (0.00)1.4 (2.25)1.5 (6.18)0.5 (0.69)1.1 (1.40)0 (0.00)
Deaths0.7 (1.10)II0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
AE of
interest		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)
Malignancy (excluding NMSC)0 (0.00)0.7 (1.12)0.7 (2.06)0 (0.00)1 (0.70)1 (1.60)
NMSC0 (0.00)0.7 (1.12)0 (0.00)0 (0.00)0 (0.00)1 (1.60)
Opportunistic infection0.7 (1.10)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
Tuberculosis0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
Hepatic disorders that were serious
or led to treatment discontinuation		0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)

*Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.

†Randomized patients in the maintenance study.

‡Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.

AE=adverse event; E/100 PY=events per 100 patient-years; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

ASTRO (SC Induction) Treat-Through
Study from Week 12 through Week 48

QUASAR (IV Induction) Randomized
Withdrawal Study Through Week 44

TREMFYA®

100 mg
SC
q8w
(N=138)

TREMFYA®

200 mg
SC
q4w
(N=140)

Placebo*

(N=136)

TREMFYA®†‡

100 mg SC
q8w
(N=186)

TREMFYA®†‡

200 mg SC
q4w
(N=190)

Placebo‡

(N=192)

Total patient-years of follow-upPY=90.9PY=88.9PY=48.6PY=144.5PY=142.6PY=125.1
Treatment-emergent AEs%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)
Any AE68.1
(263.97)		67.9
(296.92)		44.9
(314.98)		64.5
(245.73)		70.0
(345.61)		68.2
(288.63)
Serious AE2.9 (4.40)5.0 (7.87)8.8 (39.11)2.7 (3.46)6.3 (13.32)0.5 (0.80)
AE leading to discontinuation of 
study agent		4.3
(6.60)		1.4
(2.25)		5.9
(16.47)		3.8
(4.85)		2.6
(3.51)		6.8
(10.39)
Infection§31.2
(81.39)		28.6
(66.36)		19.1
(69.99)		31.7
(59.53)		31.1
(66.60)		32.8
(65.56)
Serious infection§0 (0.00)1.4 (2.25)1.5 (6.18)0.5 (0.69)1.1 (1.40)0 (0.00)
Deaths0.7 (1.10)II0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
AE of
interest		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)		%
(E/100
PY)
Malignancy (excluding NMSC)0 (0.00)0.7 (1.12)0.7 (2.06)0 (0.00)1 (0.70)1 (1.60)
NMSC0 (0.00)0.7 (1.12)0 (0.00)0 (0.00)0 (0.00)1 (1.60)
Opportunistic infection0.7 (1.10)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
Tuberculosis0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)
Hepatic disorders that were serious
or led to treatment discontinuation		0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)0 (0.00)

*Includes all placebo subjects excluding data after a subject is rescued with guselkumab.

†Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.

‡Randomized patients in the maintenance study.

§Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.

IIReported through Week 48. Intraventricular hemorrhage considered by investigator to not be related to study agent.

AE=adverse event; E/100 PY=events per 100 patient-years; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

Adverse Events
(Long-Term Extension) through 2 years (QUASAR)

Long-term extension: Treatment-Emergent adverse events in QUASAR (IV induction)2

Week 44 through Week 92

TREMFYA®*

100 mg SC
(N=162)

TREMFYA®†

200 mg SC
(N=349)

Placebo‡

(N=189)

Total patient-years of follow-upPY=145.5PY=311.1PY=147.9
Treatment-emergent AEs%
(E/100 PY)		%
(E/100 PY)		%
(E/100 PY)
Any AE64.2
(196.59)		67.6
(278.72)		64.0
(192.03)
Serious AE2.5 (4.12)5.4 (7.39)8.5 (12.85)
AE leading to discontinuation of 
study agent		3.1 (3.44)4.3 (5.14)11.6 (15.55)
Infection§33.3
(50.18)		36.1
(65.26)		32.3
(64.24)
Serious infection§1.2 (1.37)0.9 (0.96)1.1 (1.35)
Deaths0 (0.00)0 (0.00)0.5 (0.68)
AE of interest%
(E/100 PY)		%
(E/100 PY)		%
(E/100 PY)
Malignancy (excluding NMSC)0.6 (0.69)0.3 (0.32)0 (0.00)
NMSC0 (0.00)0 (0.00)0.5 (1.35)
Opportunistic Infection0 (0.00)0 (0.00)0 (0.00)
Tuberculosis0 (0.00)0 (0.00)0 (0.00)
Hepatic disorders that were serious or led to treatment discontinuation0 (0.00)0 (0.00)0 (0.00)

*Patients who were in clinical response to TREMFYA® IV induction dosing and were randomized to TREMFYA® 100 mg SC q8w on entry into the maintenance study and did not experience a dose adjustment from Week 8 through Week 32.

†Includes 1) patients who were in clinical response to TREMFYA® IV induction dosing and were randomized to TREMFYA® 200 mg SC q4w on entry into the maintenance study, and
2) patients who were randomized to placebo SC or TREMFYA® 100 mg SC q8w on entry into the maintenance study and experienced a dose adjustment from Week 8 through Week 32; and 3) patients who were not in clinical response to TREMFYA® IV at Week 12 but were in clinical response at Week 24 after receiving SC administrations of TREMFYA® from Week 12.

‡Includes 1) patients who were in clinical response to TREMFYA® IV induction dosing and were randomized to placebo SC on entry into the maintenance study and did not experience a dose adjustment from Week 8 through Week 32; 2) patients who were in clinical response to placebo IV induction dosing and received placebo SC on entry into the maintenance study.

§Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.

AE=adverse event; E/100 PY=events per 100 patient-years; IV=intravenous; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

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References: 1. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Rubin DT, Allegretti JR, Panés J, et al. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. Published online December 17, 2024. doi: 10.1016/S0140-6736(24)01927-5