Otezla phase 3 study in moderate to severe genital psoriasis

[Fred]

Otezla Resulted in Clinically and Statistically Significant Improvements in Measures of Genital Psoriasis at Week 16.

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Amgen today announced positive top-line results from the DISCREET trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement, compared with placebo, in the primary endpoint of the modified static Physician's Global Assessment of Genitalia (sPGA-G) response (defined as an sPGA-G score of clear or almost clear with at least a 2-point reduction from baseline) at week 16.

In addition, all secondary endpoints were also met with meaningful and significant improvements in Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response (defined as at least a 4-point reduction from baseline in GPI-NRS item score within the Genital Psoriasis Symptoms for subjects with a baseline score of ≥ 4); affected body surface area (BSA) change from baseline; Dermatology Life Quality Index (DLQI) change from baseline; and static Physician's Global Assessment (sPGA) response (defined as sPGA score of clear or almost clear  with at least a 2-point reduction from baseline) at week 16 with Otezla versus placebo.

"Genital psoriasis is associated with a high level of stigmatization and burden of disease and can be experienced in up to 63% of psoriasis patients over the course of their disease. Despite the use of topical therapies for the treatment of genital psoriasis, many patients still have challenges managing their disease, prompting experts to recommend the use of systemic therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The results from the DISCREET trial further add to the growing body of evidence on the safety and effectiveness of Otezla in moderate to severe plaque psoriasis, including manifestations with high unmet medical needs, such as genital psoriasis."

The type and rate of adverse events observed in this trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea and nasopharyngitis.

Patients completing the double-blind phase of the trial continued or switched to Otezla during the  extension phase of the study and will be treated through week 32. The study is ongoing and is planned to complete in the first half of 2022.

Detailed results from the 16-week double-blind phase of the study will be submitted for presentation at an upcoming medical conference.

Source: amgen.com

Otezla

[KatT]

This is good!  We've had a few members recently who suffer from genital psoriasis.

I feel all the biologics should go through the same tests....this should be standardized.

i.e.

1 - tests for types of psoriasis
2 - tests for specific affected areas
3 - tests for arthritis

That way, people could compare apples to apples and make a more informed decision.

[Fred]

This is good!  We've had a few members recently who suffer from genital psoriasis.

I feel all the biologics should go through the same tests....this should be standardized.

i.e.

1 - tests for types of psoriasis
2 - tests for specific affected areas
3 - tests for arthritis

That way, people could compare apples to apples and make a more informed decision.

Good point but treatments may work for some and not for others, I may do well on one for psoriatic arthritis but it may not work for you.

[KatT]

Yes but that happening already regardless and why the trials include many participants.  And results show the responses.

X amount had x% of improvement or reached a score of xx and so on.