Safety Profile

IN MODERATE TO SEVERE PLAQUE PSORIASIS AND ACTIVE PSORIATIC ARTHRITIS
TREMFYA^® SAFETY PROFILE

In clinical trials, 1823 patients with moderate to severe plaque psoriasis received TREMFYA^®. Of these, 1393 were exposed to TREMFYA^® for at least 6 months and 728 were exposed for at least 1 year.

IN MODERATE TO SEVERE PLAQUE PSORIASIS
ADVERSE EVENTS (AEs) IN THE 16-WEEK, PLACEBO-CONTROLLED PERIOD OF THE VOYAGE 1 AND VOYAGE 2 POOLED CLINICAL TRIALS¹*

	AEs	Serious AEs
TREMFYA® (n=823) (events per 100 patient-years of follow-up)	49% (330)	1.9% (6.3)
HUMIRA® (adalimumab)^† (n=196) (events per 100 patient-years of follow-up)	49% (440)	2.6% (9.9)
PLACEBO (n=422) (events per 100 patient-years of follow-up)	47% (317)	1.4% (4.7)

	TREMFYA® (n=823) (events per 100 patient-years of follow-up)	HUMIRA® (adalimumab)^† (n=196) (events per 100 patient-years of follow-up)	PLACEBO (n=422) (events per 100 patient-years of follow-up)
AEs	49% (330)	49% (440)	47% (317)
Serious AEs	1.9% (6.3)	2.6% (9.9)	1.4% (4.7)

IN THE 16-WEEK, PLACEBO-CONTROLLED PERIOD OF THE VOYAGE 1 AND VOYAGE 2 POOLED CLINICAL TRIALS*:

In clinical trials, infections occurred in 23% of patients in the TREMFYA® group vs 21% of patients in the placebo group through 16 weeks of treatment. The rate of serious infections for the TREMFYA® group and the placebo group was ≤0.2%. A similar risk of infection was seen in placebo-controlled trials in patients with psoriatic arthritis
The most common (≥1%) infections were upper respiratory infections, gastroenteritis, tinea infections, and herpes simplex infections; all cases were mild to moderate in severity and did not lead to discontinuation of TREMFYA®

IN MODERATE TO SEVERE PLAQUE PSORIASIS
ADVERSE REACTIONS OCCURRING IN ≥1% OF PATIENTS AND AT A HIGHER RATE THAN PLACEBO THROUGH WEEK 16 IN VOYAGE 1 AND VOYAGE 2¹*

	Upper respiratory infections^‡	Headache^§	Injection-site reactions^‖	Arthralgia	Diarrhea	Gastroenteritis^¶	Tinea infections^#	Herpes simplex infections**
TREMFYA® (n=823)	14.3% (118/823)	4.6% (38/823)	4.5% (37/823)	2.7% (22/823)	1.6% (13/823)	1.3% (11/823)	1.1% (9/823)	1.1% (9/823)
HUMIRA®^† (n=196)	10.7% (21/196)	1.0% (2/196)	7.7% (15/196)	2.0% (4/196)	1.5% (3/196)	2.0% (4/196)	0% (0/196)	0% (0/196)
PLACEBO (n=422)	12.8% (54/422)	3.3% (14/422)	2.8% (12/422)	2.1% (9/422)	0.9% (4/422)	0.9% (4/422)	0% (0/422)	0.5% (2/422)

	TREMFYA® (n=823)	HUMIRA®^† (n=196)	PLACEBO (n=422)
Upper respiratory infections^‡	14.3% (118/823)	10.7% (21/196)	12.8% (54/422)
Headache^§	4.6% (38/823)	1.0% (2/196)	3.3% (14/422)
Injection-site reactions^‖	4.5% (37/823)	7.7% (15/196)	2.8% (12/422)
Arthralgia	2.7% (22/823)	2.0% (4/196)	2.1% (9/422)
Diarrhea	1.6% (13/823)	1.5% (3/196)	0.9% (4/422)
Gastroenteritis^¶	1.3% (11/823)	2.0% (4/196)	0.9% (4/422)
Tinea infections^#	1.1% (9/823)	0% (0/196)	0% (0/422)
Herpes simplex infections**	1.1% (9/823)	0% (0/196)	0.5% (2/422)

Adverse reactions that occurred in <1% but >0.1% of the patients in the TREMFYA® group and at a higher rate than in the placebo group through Week 16 in VOYAGE 1 and VOYAGE 2 were migraine, candida infections, and urticaria
Through Week 48, no new adverse reactions were identified with TREMFYA® use and the frequency of the adverse reactions was similar to the safety profile observed during the first 16 weeks of treatment¹

IN MODERATE TO SEVERE PLAQUE PSORIASIS
AEs, SERIOUS AEs, INFECTIONS, AND SERIOUS INFECTIONS PER 100 PATIENT-YEARS THROUGH YEAR 4 IN VOYAGE 1 AND VOYAGE 2²*^††‡‡

	AEs	Serious AEs	Infections	Serious infections
TREMFYA® THROUGH YEAR 1^§§ (n=1721)	227.9	6.0	85.9	0.8
TREMFYA® YEAR 1 THROUGH YEAR 2^\|\|\|\| (n=1609)	154.4	5.9	60.1	1.0
TREMFYA® YEAR 2 THROUGH YEAR 3^¶¶ (n=1536)	132.8	4.2	56.1	0.8
TREMFYA® YEAR 3 THROUGH YEAR 4^## (n=1165)	121.3	5.2	51.7	1.0

	TREMFYA® THROUGH YEAR 1^§§ (n=1721)	TREMFYA® YEAR 1 THROUGH YEAR 2^‖‖ (n=1609)	TREMFYA® YEAR 2 THROUGH YEAR 3^¶¶ (n=1536)	TREMFYA® YEAR 3 THROUGH YEAR 4^## (n=1165)
AEs	227.9	154.4	132.8	121.3
Serious AEs	6.0	5.9	4.2	5.2
Infections	85.9	60.1	56.1	51.7
Serious infections	0.8	1.0	0.8	1.0

IN ACTIVE PSORIATIC ARTHRITIS
DISCOVER 1 AND DISCOVER 2: SAFETY PROFILE²

IN THE 24-WEEK, PLACEBO-CONTROLLED PERIOD OF THE COMBINED DISCOVER 1 AND DISCOVER 2 CLINICAL TRIALS:

The overall safety profile observed in patients with psoriatic arthritis treated with TREMFYA® is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased. In the 24-week, placebo-controlled period, combined across the two studies:
- Bronchitis occurred in 1.6% of patients in the TREMFYA® q8w group and in 1.1% in the placebo group
- Neutrophil count decreased occurred in 0.3% of patients in the TREMFYA® q8w group compared with 0% of patients in the placebo group. The majority of events of neutrophil count decreased were mild, transient, not associated with infection, and did not lead to discontinuation

*Data from 2 placebo- and active-controlled trials (VOYAGE 1 and VOYAGE 2) in 1441 patients (mean age 44 years; 70% males; 82% white) were pooled to evaluate the safety of TREMFYA® (100 mg administered subcutaneously at Weeks 0 and 4, followed by q8w). This safety information does not include data from NAVIGATE, ECLIPSE, ORION, DISCOVER 1, OR DISCOVER 2 studies.

^†US-licensed Humira®.

^‡Includes nasopharyngitis, upper respiratory tract infection (URTI), pharyngitis, and viral URTI.

^§Includes headache and tension headache.

^||Includes injection-site erythema, bruising, hematoma, hemorrhage, swelling, edema, pruritus, pain, discoloration, induration, inflammation, and urticaria.

^¶Includes gastroenteritis and viral gastroenteritis.

^#Includes tinea pedis, tinea cruris, tinea infection, and tinea manuum infections.

**Includes oral herpes, herpes simplex, genital herpes, genital herpes simplex, and nasal herpes simplex.

^††Safety summary includes all patients exposed to TREMFYA®.

^‡‡For TREMFYA®, Year 1 is defined as Week 0 to Week 52; Year 2 is defined as Week 52 to Week 104; Year 3 is defined as Week 104 to Week 156; Year 4 is defined as Week 156 to Week 204.

^§§Based on 1721 patients treated with TREMFYA® with 1662 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 1.

^||||Based on 1609 patients treated with TREMFYA® with 1570 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 2.

^¶¶Based on 1536 patients treated with TREMFYA® with 1464 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 3.

^##Based on 1165 patients treated with TREMFYA® with 867 patient-years of follow-up and a median patient-year of follow-up of 0.9 through Year 4.

***One year defined as 60 weeks (through end of study) in DISCOVER 1 and 52 weeks in DISCOVER 2.

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

CONTRAINDICATIONS
TREMFYA^® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA^®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA^® and initiate appropriate therapy.

Infections
TREMFYA^® may increase the risk of infection. Treatment with TREMFYA^® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.

Consider the risks and benefits of treatment prior to prescribing TREMFYA^® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA^® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA^® until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating treatment with TREMFYA^®. Initiate treatment of latent TB prior to administering TREMFYA^®. Monitor patients for signs and symptoms of active TB during and after TREMFYA^® treatment. Do not administer TREMFYA^® to patients with active TB infection.

Immunizations
Prior to initiating TREMFYA^®, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA^®.

ADVERSE REACTIONS
Most common (≥1%) adverse reactions associated with TREMFYA^® include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.

Please read the full Prescribing Information and Medication Guide for TREMFYA^®. Provide the Medication Guide to your patients and encourage discussion.

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IN MODERATE TO SEVERE PLAQUE PSORIASIS AND ACTIVE PSORIATIC ARTHRITIS
TREMFYA^® SAFETY PROFILE

In clinical trials, 1823 patients with moderate to severe plaque psoriasis received TREMFYA^®. Of these, 1393 were exposed to TREMFYA^® for at least 6 months and 728 were exposed for at least 1 year.

IMPORTANT SAFETY INFORMATION

INDICATIONS

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IN MODERATE TO SEVERE PLAQUE PSORIASIS AND ACTIVE PSORIATIC ARTHRITISTREMFYA® SAFETY PROFILE

In clinical trials, 1823 patients with moderate to severe plaque psoriasis received TREMFYA®. Of these, 1393 were exposed to TREMFYA® for at least 6 months and 728 were exposed for at least 1 year.

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IN MODERATE TO SEVERE PLAQUE PSORIASIS AND ACTIVE PSORIATIC ARTHRITIS
TREMFYA^® SAFETY PROFILE

In clinical trials, 1823 patients with moderate to severe plaque psoriasis received TREMFYA^®. Of these, 1393 were exposed to TREMFYA^® for at least 6 months and 728 were exposed for at least 1 year.