Tuesday, March 25, 2014

FDA Approval for Apremilast (Otezla) in Patients with Psoriatic Arthritis (PsA)


The FDA has approved apremilast (Otezla) to treat adult patients with active psoriatic arthritis (PsA). The currently approved DMARDs include biologics like THN-alpha-inhibitors and an IL-12/IL-23 inhibitor (ustekinumab).
The safety and effectiveness of apremilast (Otezla), a phosphodieasterase-4-inhibitor (PDE-4), were evaluated in three clinical trials involving 1,493 patients with active PsA. Patients treated with apremilast (Otezla) showed improvement in signs and symptoms of PsA compared to placebo. Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390091.htm

There has been a study by Arthur Kavanaugh and colleagues (Abstract No. L13) at the 2012 ACR Meeting in Washington: “Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results of a Phase 3, Randomized, Controlled Trial”. Conclusion: “Apremilast significantly improved signs and symptoms of PsA and resulted in statistically and clinically meaningful improvements in physical function. Apremilast was generally well tolerated and no new safety or laboratory signals were detected.” Lets look at some side effects: diarrhea (placebo: 2.4%; apremilast 20 mg BID: 11.3%; and apremilast 30 mg BID, 19.0%), nausea (high dose: 18.5%), headache (10.1%, and 10.7%), and more.

At the 2013 ACR Meeting in San Diego we saw even more studies.

C.J. Edwards and colleagues presented the following study [Abstract No. 311]: “Long-Term (52-Week) Results Of a Phase 3, Randomized, Controlled Trial Of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, In Patients With Psoriatic Arthritis and Current Skin Involvement (PALACE 3).” Conclusion: “Over 52 wks, APR continued to demonstrate efficacy in the treatment of PsA and associated psoriasis, including clinically meaningful improvements in signs and symptoms and physical function. APR demonstrated an acceptable safety profile with up to 52 wks of treatment and was generally well tolerated.”

M. Cutolo and colleagues presented the following study [Abstract No. 317]: “Apremilast, An Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-Term (52-Week) Improvement In Tender and Swollen Joint Counts In Patients With Psoriatic Arthritis: Results From Three Phase 3, Randomized, Controlled Trials.” Conclusion: “Over 52 wks, APR continued to demonstrate efficacy in the treatment of PsA, including clinically meaningful improvements in SJC and TJC. APR demonstrated an acceptable safety profile and was generally well tolerated for up to 52 wks.”

G. Schett and colleagues presented the following study [Abstract No. 331]: “Apremilast, An Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-Term (52-Week) Improvement In Physical Function In Patients With Psoriatic Arthritis: Results From Three Phase 3, Randomized, Controlled Trials.” Conclusion: “Over 52 wks, APR continued to demonstrate meaningful clinical response in PsA pts, including measures of physical function. APR demonstrated an acceptable safety profile and was generally well tolerated for up to 52 wks.”

There were some more studies shown at the  ACR 2013 Meeting in San Diego, for long-term safety look at the following study.

A. Kavanaugh and colleagues presented the following study [Abstract No. 310]: “ Long-Term Safety and Tolerability Of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, In Patients With Psoriatic Arthritis: Pooled Safety Analysis Of Three Phase 3, Randomized, Controlled Trials.” Conclusion: “APR demonstrated an acceptable safety profile and was generally well tolerated for up to 52 wks with no new safety concerns identified with long-term exposure. These data do not indicate a need for laboratory monitoring.”

We now must look, which group of patients really benefits from the new drug. We must compare efficacy and costs in everyday life. And we still need some head to head evaluation against established biologics. How about radiographic changes erosions as well as proliferations? Still some work to be done and still a long way to go, but

Welcome Otezla!


There sure are patients waiting for you! And hopefully Otezla will get EMEA approval soon.

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