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 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).
‡Data from the TREMFYA® treatment group and placebo→TREMFYA® 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.