TREMFYATM SAFETY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS Demonstrated Safety Profile*

In clinical trials, a total of 1748 subjects with moderate to severe plaque psoriasis received TREMFYATM. Of these, 1393 subjects were exposed to TREMFYATM for at least 6 months and 728 subjects 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>TM</sup> (guselkumab) adverse reactions through Week 16
  • In clinical trials, infections occurred in 23% of patients in the TREMFYATM group vs 21% of patients in the placebo group through 16 weeks of treatment. The rate of serious infections for the TREMFYATM 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 TREMFYATM


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>TM</sup> (guselkumab) adverse reactions through Week 16
  • Adverse reactions that occurred in <1% but >0.1% of the subjects in the TREMFYATM 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 TREMFYATM 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 TREMFYATM (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 8 weeks).

  • 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.