Psoriasis is a chronic immune-mediated disease that affects up to 2% of the population worldwide, and is associated with several co-morbidities including metabolic syndrome, cardiovascular disease, and psychiatric disorders with an overall impairment of a patient’s quality of life.  Psoriasis treatment primarily depends on disease severity, but also on co-morbidities, concomitant medications, previous therapies, adverse reactions etc.

Mild-to-moderate psoriasis is usually treated with topical treatments such as topical corticosteroids etc. and phototherapy, while systemic agents (non-biologic and biologic) are used for moderate-to-severe skin disease. These therapies can be used either as monotherapy or in combinations. Conventional systemic therapy (methotrexate, cyclosporine, and acitretin) and phototherapy are usually used as first-line therapies for moderate-to-severe psoriasis. However, the long-term continuous use of conventional systemic treatments is not recommended because of their potential organ toxicity, which frequently leads to treatment discontinuation or is a reason for contraindication.

Apremilast is a systemic therapy indicated for the treatment of moderate to severe psoriasis in adults who are candidates for systemic medication or phototherapy and for active psoriatic arthritis that is not completely responsive to disease-modifying anti-rheumatic drugs (DMARDs).  This phosphodiesterase 4 (PDE-4) inhibitor interrupts an early point of the inflammatory cascade: by blocking degradation of cyclic adenosine monophosphate (cAMP), intracellular levels of cAMP increase and antagonize the production of several pro-inflammatory cytokines, including tumor necrosis factor (TNF)–α and interleukin (IL)– 23 and IL-17.

Overall, in clinical trials, Apremilast was mostly well tolerated, and AEs were mostly mild to moderate in severity in all the study periods (short and long term). The most frequent AEs were diarrhea (17.8%), nausea (16.6%), and upper respiratory tract infections (8.4%). Tension headache, headache, nasopharyngitis, and upper respiratory infection were also reported frequently. These side effects are linked to cAMP levels which are decreased in psoriasis. Because of higher incidence of gastrointestinal adverse events dose titration of Apremilast is recommended at the start of therapy for a period of 1 week. However, despite the initial dose titration many patients develop diarrhea and nausea leading to discontinuation of therapy and poor compliance. To overcome this issue many dermatologists, use multiple different dose titration methods like slow titration over a period of 2 weeks, etc. at the start of therapy to increase the compliance of patient to the therapy.

Keeping this scenario in mind, we are conducting this study to evaluate the safety and effectiveness of different dose titration methods of Apremilast in management of patients with plaque psoriasis.