Additionally, in a post-hoc analysis of Phase 3 VOYAGE 2 clinical trial results, TREMFYA demonstrated durable clinical efficacy, itch relief and quality-of-life improvements in patients living with scalp PsO.[3] TREMFYA is the first and only fully human selective interleukin (IL)-23 inhibitor therapy approved in the
Analysis of real-world data from the IBM MarketScan Research Databases from
The TREMFYA cohort showed 2.20 times (at 12 months) and 2.28 times (at 18 months) longer persistence versus the secukinumab cohort, and 1.84 times (at 12 months) and 1.86 times (at 18 months) longer persistence versus the ixekizumab cohort.1
2,202 and 2,772 patients were identified for pairwise analysis of the TREMFYA versus secukinumab cohorts, and 2,241 and 2,007 patients for pairwise analysis of the TREMFYA versus ixekizumab cohorts, respectively.1
Analysis of real-world data from the IBM MarketScan Research Databases from
The TREMFYA cohort showed 2.00 times (at 12 months) and 2.04 times (at 18 months) longer persistence versus the secukinumab cohort, and 1.76 times (at 12 months) and 1.67 times (at 18 months) longer persistence versus the ixekizumab cohort.2
1,314 and 3,294 patients were identified for pairwise analysis of the TREMFYA and secukinumab cohorts, and 1,564 and 2,667 patients for pairwise analysis of the TREMFYA and ixekizumab cohorts, respectively.2
'These persistency real-world results potentially indicate that TREMFYA is associated with better long-term control of the symptoms associated with PsO compared with secukinumab and ixekizumab, irrespective of whether patients were bio-naive or bio-experienced,' said
In a post-hoc analysise of the Phase 3 VOYAGE 2 clinical trial, which compared TREMFYA with placebo and with adalimumab in patients with moderate to severe plaque PsO, TREMFYA demonstrated durable clinical efficacy, changes in mean Psoriasis Symptoms and Signs Diary (PSSD) itch scoresf and quality-of-life improvements in adult patients with scalp PsO:3
Among TREMFYA responders (patients achieving at least 90 percent improvement from baseline in Psoriasis Area and Severity Index [PASI 90] score)3,g remaining on treatment, mean scalp-specific Investigator Global Assessment (ss-IGA)h score rapidly improved from 2.9 at week 0 to 0.2 at week 24, and 0.3 at week 48.3
Changes in mean PSSD itch scores and Dermatology Life Quality Index scores paralleled changes in mean ss-IGA scores for all cohorts.3
'These new data underscore Janssen's commitment to provide efficacious and long-lasting treatments for people living with PsO, which may also proactively contribute to their overall well-being,' said
About VOYAGE 2 (NCT02207244; EudraCT 2014-000720-18)[9],[10]
This Phase 3, randomized, double-blind, placebo- and active comparator-controlled clinical trial was designed to evaluate the efficacy and safety of TREMFYA compared with placebo and adalimumab in adults with moderate to severe plaque PsO.9 Patients (N=992) were randomized to receive subcutaneous injections of TREMFYA 100 mg (n=496) at weeks 0, 4, and every 8 weeks (q8w) thereafter; placebo (n=248) at weeks 0, 4, and 12 followed by crossover to TREMFYA 100 mg at week 16; or adalimumab 80 mg (n=248) at week 0, 40 mg at week 1, then 40 mg every 2 weeks (q2w) until week 23. 11 Weeks 28-72 incorporated a randomized withdrawal study design.11 During the open-label period (weeks 76-252), all patients received TREMFYA 100 mg q8w.9 Physician- and patient-reported outcomes were assessed. 11 Efficacy was analyzed using prespecified treatment failure rules (patients discontinuing due to lack of efficacy, worsening of PsO, or use of a prohibited treatment were considered non-responders). 11 Data were combined for patients randomized to TREMFYA and for those originally randomized to placebo who later crossed over to TREMFYA at week 16. 11 Patients were treated and followed for up to 264 weeks.9
Co-primary endpoints of the study were proportions of patients receiving TREMFYA versus placebo achieving IGA 0/1 (clear/almost clear) (84 vs 9 percent, respectively [P
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