TREMFYA® SAFETY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS Safety Profile*

In clinical trials, 1748 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.

Adverse Events in the 16-week, Placebo-Controlled Period of THE VOYAGE 1 AND VOYAGE 2 POOLED CLINICAL TRIALS1

TREMFYA<sup>®</sup> (guselkumab) adverse reactions through Week 16

VOYAGE 1: ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, INFECTIONS, AND SERIOUS INFECTIONS PER 100 PATIENT-YEARS THROUGH WEEK 1004

VOYAGE 1: Adverse events, serious adverse events, infections, and serious infections per 100 patient-years through Week 100

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%

  • 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®


Adverse reactions OCCURING IN ≥1% of patients and at a higher rate than placebo through Week 16 in VOYAGE 1 and VOYAGE 21

TREMFYA<sup>®</sup> (guselkumab) adverse reactions through Week 16
  • 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

  • *Data from 2 placebo- and active-controlled trials (VOYAGE 1 and VOYAGE 2) in 1441 subjects (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 every 8 weeks thereafter).

  • US-licensed Humira®.

  • Data from the TREMFYA® treatment group and placeboTREMFYA® treatment group (after Week 16) in VOYAGE 1 were pooled (N=494) to evaluate the safety of TREMFYA® (100 mg administered subcutaneously at Weeks 0 and 4, followed by q8w through Week 100).

  • §Based on 494 patients treated with TREMFYA® with 394 patient-years of follow-up and a median patient-year of follow-up of 0.9 years through Week 48.

  • ||Based on 494 patients treated with TREMFYA® with 847 patient-years of follow-up and a median patient-year of follow-up of 1.9 years through Week 100.

  • 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.