Otezla– A new drug got FDA approval for Psoriatic arthritis

The US Food and Drug Administration (FDA) approved Otezla (Apremilast) for the treatment of Psoriatic arthritis in March 2014.

This drug is a small-molecule inhibitor of phosphodiesterase 4(PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibitors refer to the class drugs used to block the degradative action of phosphodiesterase 4 (PDE4) on cyclicadenosine monophosphate (cAMP). It inhibits an enzyme known as phosphodiesterase 4 or PDE4. PDE4 plays a major role for controlling the inflammatory action in cellular level, which finally affect the level of inflammation associated with psoriatic arthritis. By regulating inflammation within immune cells Otezla improves joint tenderness and swelling in people with psoriatic arthritis.

Otezla is available as a tablet for oral administration. Treatment is started with a 5 days titration periodtitrated from Day 1 to Day 5. Following the 5-day titration, recommended maintenance dosage of 30 mg twice daily is provided on Day 6. The initial titration period has been planned to reduce the gastrointestinal symptoms associated with initial therapy.The common side effects associated with Otezla are diarrhea, nausea, and headache.

The FDA approval of Otezla was based on three multi-centric, randomized, double-blinded, placebo-controlled trials of similar design. Total 1,493 adult patients participated. During the course of these studies, patients were randomly assigned to placebo, Otezla 20 mg or 30 mg, given orally twice daily. Titration was used over the first 5 days. Patients were allowed to receive stable doses of concomitant medication. Patients treated with Otezla manifested much better efficacy compared to those treated with Placebo. About 38 percent of patients treated with Otezla   manifested 20-percent improvement measured as arthritis severity scores after 16-weeks of treatment. Arthritis severity scores represent parameters usually determined by examining swelling in and around the joints, pain, joint tenderness, physical function and morning stiffness. Thus Otezla provides a new treatment option for of patients with Psoriatic arthritis.

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