ASP015K phase 2a for psoriasis shows good results

[Fred]

If you have been following the development of ASP015K which we first reported here in 2012 Janssen & Astellas to develop ASP015K (JAK) inhibitor you may be interested in these phase 2a results that show ASP015K has demonstrated dose-dependent improvements in clinical and histological measures of severity over 6 weeks of treatment. And t all doses, ASP015K was well tolerated, with no reported serious adverse events (AEs).

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Background:
Many immune-mediated disorders, including psoriasis, involve cytokine signalling via Janus kinase (JAK) enzymes. ASP015K (also designated JNJ-54781532), a novel oral JAK inhibitor, has shown moderate selectivity for JAK3 over JAK1 and JAK2 in enzyme assays.

Objectives:
The objective of this study was to evaluate the efficacy and safety of escalating, sequentially grouped, doses of ASP015K vs. placebo in patients with moderate-to-severe psoriasis.

Methods:
This phase 2a multicentre, double-blind, randomized, placebo-controlled study (NCT01096862) enrolled 124 patients with moderate-to-severe plaque psoriasis. Five sequential ASP015K cohorts were enrolled, consisting of four twice-daily dosing groups (10, 25, 60, 100 mg) and one once-daily dosing group (50 mg) for 6 weeks.

Results:
The primary efficacy end point [mean change in Psoriasis Area and Severity Index score from baseline to end of treatment (EOT; day 42)] significantly favoured ASP015K (overall treatment effect; P < 0·001) vs. placebo, with greater improvements at higher doses. By EOT, the secondary end points [Physician Static Global Assessment (PSGA) score, percentage of patients achieving PSGA success, and change in percentage, body surface area (BSA)] also improved with ASP015K vs. placebo (P < 0·001 for PSGA score and BSA; P < 0·01 for PSGA success). Epidermal thickness and proliferation decreased from baseline with ASP015K vs. placebo. ASP015K was generally well tolerated, with no serious adverse events (AEs) reported.

Conclusions:
In patients with moderate-to-severe psoriasis, ASP015K demonstrated dose-dependent improvements in clinical and histological measures of severity over 6 weeks of treatment. At all doses, ASP015K was well tolerated, with no reported serious AEs.

Source: onlinelibrary.wiley.com

*Funding: Astellas for editorial assistance & Complete Healthcare Communications, Inc.

[jiml]

If you have been following the development of ASP015K which we first reported here in 2012 Janssen & Astellas to develop ASP015K (JAK) inhibitor you may be interested in these phase 2a results that show ASP015K has demonstrated dose-dependent improvements in clinical and histological measures of severity over 6 weeks of treatment. And t all doses, ASP015K was well tolerated, with no reported serious adverse events (AEs).

Quote:

---

Background:
Many immune-mediated disorders, including psoriasis, involve cytokine signalling via Janus kinase (JAK) enzymes. ASP015K (also designated JNJ-54781532), a novel oral JAK inhibitor, has shown moderate selectivity for JAK3 over JAK1 and JAK2 in enzyme assays.

Objectives:
The objective of this study was to evaluate the efficacy and safety of escalating, sequentially grouped, doses of ASP015K vs. placebo in patients with moderate-to-severe psoriasis.

Methods:
This phase 2a multicentre, double-blind, randomized, placebo-controlled study (NCT01096862) enrolled 124 patients with moderate-to-severe plaque psoriasis. Five sequential ASP015K cohorts were enrolled, consisting of four twice-daily dosing groups (10, 25, 60, 100 mg) and one once-daily dosing group (50 mg) for 6 weeks.

Results:
The primary efficacy end point [mean change in Psoriasis Area and Severity Index score from baseline to end of treatment (EOT; day 42)] significantly favoured ASP015K (overall treatment effect; P < 0·001) vs. placebo, with greater improvements at higher doses. By EOT, the secondary end points [Physician Static Global Assessment (PSGA) score, percentage of patients achieving PSGA success, and change in percentage, body surface area (BSA)] also improved with ASP015K vs. placebo (P < 0·001 for PSGA score and BSA; P < 0·01 for PSGA success). Epidermal thickness and proliferation decreased from baseline with ASP015K vs. placebo. ASP015K was generally well tolerated, with no serious adverse events (AEs) reported.

Conclusions:
In patients with moderate-to-severe psoriasis, ASP015K demonstrated dose-dependent improvements in clinical and histological measures of severity over 6 weeks of treatment. At all doses, ASP015K was well tolerated, with no reported serious AEs.

Source: onlinelibrary.wiley.com

*Funding: Astellas for editorial assistance & Complete Healthcare Communications, Inc.

More good news for the psoriasis community, particarly those that have an aversion to needles,

It's a new approach and hopefully one of these new drugs will work on some where others have failed

Something to look out for in the future