INDICATION

TREMFYA^® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

TREMFYA^® is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. TREMFYA^® is intended for use under the guidance and supervision of a physician. Patients may self-inject with TREMFYA^® after physician approval and proper training.

In moderate to severe plaque psoriasis

TREMFYA^® has set the bar at PASI 90 as a primary endpoint in phase 3 trials:

Placebo-controlled period, co-primary endpoints at Week 16

Based on the results of an analysis of 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American sites [ie, US and Canada]).

PASI, Psoriasis Area and Severity Index.

PASI 90=Proportion of patients who achieved 90% or more reduction (or improvement) in PASI score from baseline; IGA 0/1=Proportion of patients who achieved an IGA score of cleared (0) or minimal (1) using a 5-point scale where psoriatic lesions are graded by the investigator for induration, erythema, and scaling on a scale of 0 to 4: cleared, except for residual discoloration (0), minimal (1), mild (2), moderate (3), or severe (4).

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Individual results may vary. Photos are of a real patient from VOYAGE 2 (North American site) who received TREMFYA^® 100 mg at Weeks 0, 4, and q8w thereafter through Week 48. Other areas affected (not shown) yielded similar results to those depicted here. Images are for illustrative purposes only and are used with permission from Janssen Biotech, Inc.

Study Designs: In VOYAGE 1 and VOYAGE 2, 837 and 992 patients were randomized to placebo (n=174, n=248), TREMFYA^® 100 mg subcutaneous (SC) injection every 8 weeks (q8w) after Weeks 0 and 4 (n=329, n=496), or Humira^® (adalimumab) 80 mg SC at Week 0, 40 mg at Week 1, and 40 mg every 2 weeks thereafter (n=334, n=248), respectively. Eligible patients (≥18 years of age) had moderate to severe plaque psoriasis (ie, Investigator’s Global Assessment [IGA] score ≥3, Psoriasis Area and Severity Index [PASI] score ≥12, and body surface area [BSA] involvement ≥10%) for at least 6 months and were candidates for systemic therapy or phototherapy. The studies comprised of a placebo-controlled period (Weeks 0 to 16) after which patients taking placebo crossed over to receive TREMFYA^® at Weeks 16 and 20. In VOYAGE 1, patients continued TREMFYA^® q8w thereafter through Week 48, and there was an active-comparator–controlled period when TREMFYA^® was compared with Humira^® from Week 0 through Week 48. The VOYAGE 2 study also included an active-comparator–controlled period with Humira^® (Weeks 0 to 24). In VOYAGE 2, at Week 28, subjects who were randomized to TREMFYA^® 100 mg SC q8w at Week 0 and those who were PASI 90 responders were re-randomized either to placebo or TREMFYA^® 100 mg SC q8w in a 1:1 ratio.

View the MPR/Dermatology Advisor Fact Pack to learn more about how to get patients started on biologic treatment, including peer insights on the use of biologics for moderate to severe plaque psoriasis, and results from clinical trials for TREMFYA^®.