Otezla for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla ( Apremilast ) is an oral small-molecule inhibitor of phosphodiesterase 4 ( PDE4 ) specific for cyclic adenosine monophosphate ( cAMP ). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators.
The specific mechanism(s) by which Apremilast exerts its therapeutic action in patients with psoriasis or psoriatic arthritis is not well defined.
Otezla is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is also indicated for the treatment of adult patients with active psoriatic arthritis.
ESTEEM 1 and 2 are two large pivotal phase III randomized, placebo-controlled studies evaluating Apremilast in patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy.
Approximately 1,250 patients were randomized 2:1 to receive either Apremilast 30 mg twice daily or placebo after an initial five-day titration period, for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo patients were switched to Apremilast 30 mg twice daily through week 32, and a randomized withdrawal phase for responders from week 32 to week 52 based on their initial Apremilast randomization and PASI-75 response.
Patients who are allergic to Apremilast or to any of the ingredients in Otezla should not take Otezla. Women should inform their doctor if they are pregnant, planning to become pregnant, or planning to breastfeed. Otezla has not been studied in pregnant women or in women who are breastfeeding. These are not all the possible side effects with OTEZLA.
In clinical trials, the most common side effects with Apremilast were diarrhea, nausea and headache, which occurred in the first two weeks and tended to lessen with continued treatment.
In clinical trials, approximately 6.1% of the people taking Otezla for psoriasis discontinued treatment due to an adverse reaction.
In clinical trials, 10 to 12% of people taking Otezla reported unexplained weight loss of 5 to 10% during their trial period. It is recommended that people taking Otezla have their weight monitored regularly. ( Xagena )
Source: Celgene, 2014