Tremfya(guselkumab)

Tremfya (guselkumab) is a drug indicated for the treatment of adult patients with moderately to severely active ulcerative colitis and active psoriatic arthritis. The BLA for Tremfya was submitted on November 16, 2016, and it received approval on September 11, 2024, for the new indication of ulcerative colitis. New drug presentations include 200 mg/20 mL (10 mg/mL) single-dose vial, 200 mg/2 mL single-dose prefilled pen (Tremfya Pen), and 200 mg/2 mL single-dose prefilled syringe. A pediatric study waiver was granted for ages less than 2 years.

Efficacy findings include statistically significant results for clinical remission (primary endpoint) and fatigue response (defined as ≥7-point improvement from induction baseline in PROMIS-Fatigue SF-7a). Secondary endpoints with statistically significant results at Week M-44 included corticosteroid-free clinical remission, endoscopic improvement, histologic endoscopic mucosal improvement (HEMI), and maintenance of clinical remission. IGA 0/1 response rates ranged from 80.5% to 100.0%. Subjects with prior biologic/JAK inhibitor exposure were 51.6% in IS-2 and 45.6% in MS.

Safety data indicates a total of 15 MACE events across pooled studies, with annualized MACE rates of 0.84 and 0.63 per 100 subject-years. The impact of anti-drug antibodies (ADA) on pharmacokinetics (PK) showed no impact in 19.6% of cases, while the impact could not be determined in 41.3%. Negative impact of neutralizing antibodies (NAb) on PK was observed in 100% of cases. Injection site reaction (ISR) incidence was 11.5% and 10.9% in ADA+ subjects, compared to 5.2% and 5.5% in ADA- subjects.