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Saturday, 06/30/2018 1:19:32 PM

Saturday, June 30, 2018 1:19:32 PM

Post# of 402819
With PRU Dbase lock announced -- countdown on to Topline Results

Pulled Otezla/Apremilast Ph2 results... 24% Active vs 10% Placebo PASI 75

PRU gets anywhere close to this spread (e.g., 21/10, 23/13, 22/11, even 19/9) and think IPIX has a winner, a Partnerable drug ---- CELG was later able to get Otezla efficacy up into the high 20s/low 30s, across 16 weeks (ours is 12 weeks, like in this Otezla Ph2) so efficacy slope will be worth watching -- did effect plateau at 12 weeks or is it still on the climb (ie, 16 weeks and we get even better numbers)

At least that's what I'm hoping - comparable results to Otezla at same stage...

https://www.semanticscholar.org/paper/Efficacy-and-safety-of-apremilast-in-subjects-with-Papp-Kaufmann/4e666962332fbfc0683af22c2e9e071a069d235b

RESULTS More subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI-75) vs. placebo (24.4% vs. 10.3%; P = 0.023). A similar proportion of subjects receiving apremilast 20 mg QD and placebo achieved PASI-75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20 mg QD (P = 0.021 vs. placebo) and 52.1% for apremilast 20 mg BID (P < 0.001). Apremilast 20 mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P < 0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (> 90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20 mg QD (knee surgery) and in one receiving apremilast 20 mg BID (worsening psoriasis). The panic attack was considered treatment-related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported.

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