Apremilast is an investigational drug being studied in patients with psoriasis, psoriatic arthritis and other chronic inflammatory diseases such as ankylosing spondylitis, Behcet’s disease, and rheutmatoid arthritis.
Apremilast, which is part of a class of drugs called phosphodiesterase-4 (PDE4) inhibitors, works by blocking the action of the PDE4 molecule, which is involved in inflammation – a central aspect of chronic inflammatory diseases.
Because apremilast is not currently approved for commercial use, the treatment is only available in clinical trials.
In both the PALACE and ESTEEM clinical trials, most side effects were mild to moderate.
In PALACE-2 trial, patients with psoriatic arthritis reported the following side effects most frequently:
- diarrhea
- headache
- nausea
- fatigue
- nasopharyngitis (inflammation of the nasal passages and throat)
During ESTEEM-1 and 2 trials at least 5% of patients had:
- nausea
- upper respiratory tract infection
- diarrhea
- nasopharyngitis (inflammation of the nasal passages and throat)
- headache
- joint pain (placebo)
- gastroenteritis (inflammation of the lining of the stomach or intestines)
- upset stomach
- Eight serious adverse events occurred (three each, placebo and apremilast 20 mg; two, apremilast 30 mg); none were judged to be related to apremilast.
Celgene is developing novel orally available small molecules that inhibit the production of multiple proinflammatory mediators including interleukin-2 (IL-2), IL-12, interferon-gamma, TNF-alpha, leukotrienes, and nitric oxide synthase.
Our lead investigational drug, CC-10004 (apremilast) is an oral compound that is being studied in multiple Phase III clinical trials for the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. We successfully completed our early stage studies, demonstrating clinical activity and tolerability and meeting safety endpoints in a placebo controlled proof-of mechanism trial in moderate-to-severe psoriasis and psoriatic arthritis. With the initiation of six multi-center international clinical trials, we are advancing the clinical development of CC-10004.
CC-11050 is currently in Phase I clinical trials for chronic inflammatory diseases.
CC-10004 and CC-11050 are investigational products and are not approved for any indications.
In clinical trials, apremilast doses of 20 or 30 mg, taken by mouth twice daily, have been studied, as well as doses of 40 mg taken once daily.