Friday, February 20, 2015

Otezla approved in Europe for the treatment of psoriatic arthritis

Roughly, it has taken a year for Otezla (Apremilast) to be approved in Europe. I’ve written about Otezla before: And I’ve also written on Otezla yesterday (in German) because Celgene supplied me with the fact sheet on Otezla:

Otezla is available on prescription in rheumatology "as monotherapy or in combination with disease-modifying anti-rheumatic drugs (DMARDs ) for the treatment of active psoriatic arthritis (PsA ) in adult patients who have an inadequate response to previous DMARD therapy or are intolerant to this therapy". EMEA decided to approve the drug according to the PALACE 1-3 studies, which had observed about 1500 patients. More patients achieved a significantly higher ACR20 response in comparison to placebo (after 16 weeks). There was a reduction in the number of swollen and painful joints. Other improvements included dactylitis , enthesitis , quality of life etc.; and not to forget skin involvement of psoriasis. Most frequent adverse events were: diarrhea, nausea, upper respiratory tract infections.

Did I desperately wait for Otezla to be approved? Yes and no. There are not as many patients as in rheumatoid arthritis, which is one factor that there aren’t as many studies as in rheumatoid. There is a lack of DMARDs, what works in rheumatoid doesn’t have to work in psoriatic arthritis. Some rheumatologists too eagerly diagnose psoriatic arthritis, which made me doubt the diagnosis if not made by myself – and I even doubt myself and review the diagnosis. The lack of DMARDs for the treatment of psoriatic arthritis results in a yes for Otezla. But I have to admit that I don’t have a patient, where I would try it right now. How come will you ask. That’s easy to answer. Ustekinumab (Stelara) isn’t on the market so long that I’d seen enough patients to fail, so I'm not in need of a next drug. Actually I’m still working out the place of Stelara under real life conditions.

To sum it up: I’m happy to have the option to prescribe Otezla, but I’m uncertain about when I’ll have to prescribe it.

I've looked at the PASI 90 percentages in the ESTEEM 1 and 2 studies - less than 10% of patients on apremilast achieved a PASI 90, which is defenitely less than 45% of patients on ustekinumab, who achieved a PASI 90 (ACCEPT).
The price level is still uncertain in Germany; I've just been told 17,000 € per year. And I've seen around 22,000-23,000 US$ for the US. The price levels are too high for a small molecule.

1 comment:

  1. Jennifer Davies has left a new comment on your post "Otezla approved in Europe for the treatment of pso...":

    I think I'm with you on this one. Having the option for different medication is always nice, especially if something like an allergy shows up. But it's not necessary to jump to the next drug simply because it's new. This is why it's important to constantly be seeing a professional who can diagnose and prescribe for your specific situation.