For US Healthcare Professionals

I am a

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

Adverse Events (Induction)

Treatment-emergent adverse events through Week 12 in a phase 3 induction study1,2

IV Induction

TREMFYA®

200 mg IV*

Placebo
IV*

N (treated patients)*421280
Average duration of follow-up, weeks12.211.9
Patients with 1 or more:
Adverse events, n (%)208
(49.4%)		138 (49.3%)
Serious adverse events, n (%)12 (2.9%)20 (7.1%)
Infections,† n (%)66 (15.7%)43 (15.4%)
Serious infections,† n (%)3 (0.7%)1 (0.4%)

Common adverse reactions

  • Common adverse reactions that occurred in ≥2% of patients in the TREMFYA® group and at a higher rate than placebo in the induction studies were respiratory tract infections (8.8% vs 7.3%)1
  • Within 1 hour of infusion, no adverse events were considered serious or resulted in treatment discontinuation2

*Randomized patients in the induction study who received at least 1 dose of study intervention.2

†Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.2

IV=intravenous; MedDRA=Medical Dictionary for Regulatory Activities.

Adverse Events (Maintenance)

Summary of treatment-emergent adverse events through Week 44 (up to dose adjustment) in the maintenance study2

Randomized TREMFYA®*

100 mg SC
q4w 

Randomized placebo

(Induction Responder)

N (treated patients)†186192
Average duration of follow-up, weeks40.534.0
Patients with 1 or more:
Adverse events, n (%)120 (64.5%)131 (68.2%)
Serious adverse events, n (%)5 (2.7%)1 (0.5%)
Infections,‡ n (%)59 (31.7%)63 (32.8%)
Serious infections,‡ n (%)1 (0.5%)0

Randomized TREMFYA®

200 mg SC q8w

Randomized placebo

(Induction Responder)

N (treated patients)†190192
Average duration of follow-up, weeks39.234.0
Patients with 1 or more:
Adverse events, n (%)133 (70.0%)131 (68.2%)
Serious adverse events, n (%)12 (6.3%)1 (0.5%)
Infections,‡ n (%)59 (31.1%)63 (32.8%)
Serious infections,‡ n (%)2 (1.1%)0

*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.2

†Randomized patients in the maintenance study.2

‡Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.2

Randomized TREMFYA®*

100 mg SC q8w

200 mg SC q4w

Randomized placebo

(Induction Responder)

N (treated patients)†186190192
Average duration of follow-up, weeks40.539.234.0
Patients with 1 or more:
Adverse events, n (%)120 (64.5%)133 (70.0%)131 (68.2%)
Serious adverse events, n (%)5 (2.7%)12 (6.3%)1 (0.5%)
Infections,‡ n (%)59 (31.7%)59 (31.1%)63 (32.8%)
Serious infections,‡ n (%)1 (0.5%)2 (1.1%)0

*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.2

†Randomized patients in the maintenance study.2

‡Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.2

Adverse reactions occurring in ≥3% of patients through Week 441 and at a higher rate than placebo

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 infection6 (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.2

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

Adverse reactions of interest—
malignancy data2

TREMFYA®

100 mg SC q8w Randomized (total patients)

Placebo

Randomized (total patients)

Analysis set: UC maintenance randomized safety*186192
All malignancies†04 (2.1%)§
Nonmelanoma skin cancer02 (1.0%)
Malignancies other than nonmelanoma skin cancer02 (1.0%)

TREMFYA®

200 mg SC q4w Randomized (total patients)

Placebo

Randomized (total patients)

Analysis set: UC maintenance randomized safety*190192
All malignancies†1 (0.5%)‡4 (2.1%)§
Nonmelanoma skin cancer02 (1.0%)
Malignancies other than nonmelanoma skin cancer1 (0.5%)2 (1.0%)

TREMFYA®

100 mg SC q8w Randomized
(total patients)

TREMFYA®

200 mg SC q4w Randomized
(total patients)

Placebo

Randomized
(total patients)

Analysis set: UC maintenance randomized safety*186190192
All malignancies†01 (0.5%)‡4 (2.1%)§
Nonmelanoma skin cancer002 (1.0%)
Malignancies other than nonmelanoma skin cancer01 (0.5%)2 (1.0%)

*Includes data up to the time of dose adjustment for subjects who had a dose adjustment.2

†There were an additional 3 participants in the all-treated analysis set with malignancies.2

‡There was an additional malignancy in the nonrandomized TREMFYA® 200-mg q4w group (clear cell renal carcinoma).2

§There was an additional malignancy in the nonrandomized placebo group (breast cancer) and in another participant in the placebo to TREMFYA® dose adjustment group (squamous cell carcinoma).2

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

Serious Adverse Events

Adverse Events (Long-term Extension) Through 2 Years

Treatment-emergent adverse events from Week 44 to Week 92 in LTE2

TREMFYA®
100 mg

q8w*

Placebo‡

Analysis set: LTE all-treated set, N162189
Average duration of follow-up (weeks)46.940.8
Average exposure (number of administrations)10.99.4
Total patient-years
of follow-up from
Week 44 to Week 92		145.5147.9
Patients with event/100 patient-years
of follow-up (95% CI)
Adverse
events (AEs)		71.49
(58.41-86.62)		81.82
(67.89-97.76)
Serious AEs2.75
(0.75-7.04)		10.82
(6.18-17.57)
Infections§37.12
(27.88-48.43)		41.25
(31.55-52.98)
Serious infections§1.37
(0.17-4.97)		1.35
(0.16-4.89)
AEs leading to study discontinuation3.44
(1.12-8.02)		14.88
(9.32-22.52)

TREMFYA®
200 mg

q4w†

Placebo‡

Analysis set: LTE all-treated set, N349189
Average duration of follow-up (weeks)46.540.8
Average exposure (number of administrations)11.49.4
Total patient-years
of follow-up from
Week 44 to Week 92		311.1147.9
Patients with event/100 patient-years
of follow-up (95% CI)
Adverse
events (AEs)		75.87
(66.50-86.19)		81.82
(67.89-97.76)
Serious AEs6.11
(3.68-9.54)		10.82
(6.18-17.57)
Infections§40.51
(33.74-48.23)		41.25
(31.55-52.98)
Serious infections§0.96
(0.20-2.82)		1.35
(0.16-4.89)
AEs leading to study discontinuation4.82
(2.70-7.95)		14.88
(9.32-22.52)

TREMFYA® 100 mg

q8w*

TREMFYA® 200 mg

q4w†

Placebo‡

Analysis set: LTE all-treated set, N162349189
Average duration of follow-up (weeks)46.946.540.8
Average exposure (number of administrations)10.911.49.4
Total patient-years of follow-up from Week 44 to Week 92145.5311.1147.9
Patients with event/100 patient-years of follow-up (95% CI)
Adverse events (AEs)71.49 (58.41-86.62)75.87 (66.50-86.19)81.82 (67.89-97.76)
Serious AEs2.75 (0.75-7.04)6.11 (3.68-9.54)10.82 (6.18-17.57)
Infections§37.12 (27.88-48.43)40.51 (33.74-48.23)41.25 (31.55-52.98)
Serious infections§1.37 (0.17-4.97)0.96 (0.20-2.82)1.35 (0.16-4.89)
AEs leading to study discontinuation3.44 (1.12-8.02)4.82 (2.70-7.95)14.88 (9.32-22.52)

Additional Safety Through 2 Years2

Patients with malignancy per 100 patient-years

  • TREMFYA® 200 mg SC q4w: 0.32 (n=349; 95% CI=0.01-1.79)
  • TREMFYA® 100 mg SC q8w: 0.69 (n=162; 95% CI=0.02-3.83)
  • Placebo SC: 0.68 (n=189; 95% CI=0.02-3.77)

Patient-years of follow-up from Week 44 through Week 92 for TREMFYA® 200 mg SC (311.1), TREMFYA® 100 mg SC (145.5), and placebo (147.9)

*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 32.2

†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 12.2

‡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.2

§Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.2

CI=confidence interval; LTE=long-term extension; MedDRA=Medical Dictionary for Regulatory Activities; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

teal vector
teal vector
global

Schedule a meeting with a local representative of Johnson & Johnson

Request a rep
Explore TREMFYA® Dosing

References: 1. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.