Zoryve for psoriasis phase 3 results

[Fred]

Arcutis Biotherapeutics have published positive results from a pivotal Phase 3 study evaluating the efficacy and safety of Zoryve (roflumilast) foam 0.3% as a once-daily monotherapy treatment for psoriasis of the scalp and body.

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The study showed that treatment with investigational ZORYVE foam resulted in significant improvements across multiple efficacy endpoints, including the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, as well as key secondary endpoints. The data also show improvement in pruritus (itch) was observed as early as 24 hours after the first application.

These compelling results demonstrate that ZORYVE foam 0.3% may provide rapid and significant relief of plaques anywhere on the body and is well-tolerated according to both investigator and patient-reported assessments. The foam formulation is particularly beneficial for its versatility in treating hair-bearing and non-hair-bearing skin, which could ultimately help patients adhere to their treatment.

A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis (ARRECTOR), was a Phase 3, randomized, double-blinded, vehicle-controlled trial which enrolled 432 adults and adolescents aged 12 years and older with plaque psoriasis affecting the scalp and body, across 49 sites in the United States and Canada.

Significantly greater proportions of individuals treated with ZORYVE foam 0.3% achieved the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline. At Week 8, 66.4% of individuals treated with ZORYVE foam 0.3% achieved S-IGA success compared to 27.8% for vehicle (P<0.0001). At Week 8, 45.5% of patients treated with ZORYVE foam achieved B-IGA success compared to 20.1% for vehicle (P<0.0001).

Other key findings include:

• ZORYVE foam provided a clinically meaningful improvement in scalp itch. 65.3% of individuals treated with ZORYVE achieved a clinically significant reduction in itch compared to 30.3% of individuals treated with vehicle at Week 8 (P<0.0001) as measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Significant improvement was seen in the ZORYVE treatment group as early as Week 2. The data also demonstrated improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS) at Week 8, with 63.1% of those treated with ZORYVE foam 0.3% achieving a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle (P<0.0001). Significant improvement was seen in the ZORYVE treatment group as early as Week 2.
  
  
• Importantly, there was a greater improvement in itch observed with ZORYVE within 24 hours after the first application compared to vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=0.0164). This improvement over vehicle within 24 hours after the first application was also observed in body itch (as measured by WI-NRS change from baseline, relative to vehicle; nominal P=0.0094).
  
  
• At Week 8, 70.9% of those treated with ZORYVE foam versus 31.3% treated with vehicle achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) (P<.001), another secondary endpoint.
  
• Similarly, 50.1% of people treated with ZORYVE foam 0.3% achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI-75), a key secondary endpoint, as compared to 16.8% of those treated with vehicle at Week 8 (P<.001).
  

ZORYVE foam was well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar in both active treatment and vehicle arms. The most frequent adverse events in the ZORYVE foam arm (≥1%) included headache, diarrhea, and nausea. Investigator-rated application-site tolerability was similar between ZORYVE and vehicle groups, with investigators reporting no evidence of irritation for at least 99.2% of all patients at all time points. Patient-rated application-site tolerability was also similar between ZORYVE and vehicle with at least 94.4% of patients reporting no or mild sensation on local tolerability assessments at all time points.

Source: arcutis.com