For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
Safety Profile
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 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) |
IN MODERATE TO SEVERE PLAQUE PSORIASIS
AEs, SERIOUS AEs, INFECTIONS, AND SERIOUS INFECTIONS PER 100 PATIENT-YEARS THROUGH YEAR 5 IN VOYAGE 1 AND VOYAGE 22*††‡‡
AEs | Serious AEs | Infections | Serious infections | |
---|---|---|---|---|
TREMFYA® THROUGH YEAR 1§§ (n=1721) |
228.2 | 6.0 | 86.0 | 0.8 |
TREMFYA® YEAR 1 THROUGH YEAR 2|||| (n=1609) |
155.1 | 5.9 | 60.1 | 1.0 |
TREMFYA® YEAR 2 THROUGH YEAR 3¶¶ (n=1536) |
134.0 | 4.2 | 56.2 | 0.8 |
TREMFYA® YEAR 3 THROUGH YEAR 4## (n=1470) |
114.8 | 4.9 | 46.9 | 1.0 |
TREMFYA® YEAR 4 THROUGH YEAR 5*** (n=1361) |
82.9 | 3.4 | 35.4 | 0.6 |
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=1470) |
TREMFYA® YEAR 4 THROUGH YEAR 5*** (n=1361) |
|
AEs | 228.2 | 155.1 | 134.0 | 114.8 | 82.9 |
Serious AEs | 6.0 | 5.9 | 4.2 | 4.9 | 3.4 |
Infections | 86.0 | 60.1 | 56.2 | 46.9 | 35.4 |
Serious infections | 0.8 | 1.0 | 0.8 | 1.0 | 0.6 |
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:
Warnings and precautions include infections, tuberculosis (TB), hypersensitivity, and immunizations.No labeled warnings or precautions for malignancy or inflammatory bowel disease.1
Initially evaluate for TB and monitor patients for signs and symptoms of TB infection during and after treatment.NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT.1
*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®.
‡‡In the open-label extension, an event was included in Year 1 if it occurred within 52 weeks after the first TREMFYA® administration; in Year 2 if it occurred between 52 weeks and 104 weeks after the first TREMFYA® administration; in Year 3 if it occurred between 104 weeks and 156 weeks after the first TREMFYA® administration; in Year 4 if it occurred between 156 weeks and 208 weeks after the first TREMFYA® administration; in Year 5 if it occurred beyond 208 weeks after the first TREMFYA® administration.
§§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 1497 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 3.
##Based on 1470 patients treated with TREMFYA® with 1417 patient-years of follow-up and a median patient-year of follow-up of 1.0 through Year 4.
***Based on 1361 patients treated with TREMFYA® with 1020 patient-years of follow-up and a median patient-year of follow-up of 0.8 through Year 5.
†††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.