Apremilast, an orally administered small molecule inhibitor of phosphodiesterase 4 (PDE4), has been licensed by the US Food and Drug Administration for the management of active psoriatic arthritis (March 21, 2014) and moderate to severe plaque psoriasis (September 23, 2014). It has got approval from Drug Controller General of India for marketing in India in 2017. The drug has drawn much attention from the practising dermatologists for its commendable safety profile and prescription convenience. Introduced initially as an orally administered small molecule in psoriasis patients, the drug has now been used in various other indications as evident by the recent surge in literature for its off-label uses. Being a relatively new drug in the treatment armamentarium of psoriasis and other inflammatory dermatoses; in this review, we will discuss various practical aspects of prescribing oral apremilast, based on the current and emerging literature.

Apremilast in psoriasis and beyond: Big hopes on a small molecule

Toward the elimination of hepatitis C in the United States

Background: Psoriasis continues to have unmet needs in its management despite introduction of newer molecules. Monotherapy with these newer agents may not achieve therapeutic goals in all cases, hence necessitating their combinations with other molecules. Improved understanding of newer as well as conventional treatment modalities and experiences in their combinations hence necessitates therapeutic guidelines for their use in psoriasis. Objective: To review the combinations of treatments reported in literature and recommendations for their use based on best current evidence in literature. Methods: A literature review of MEDLINE database for studies evaluating combinations of newer therapies with conventional therapies in psoriasis was done. Newer therapies were identified as biologic disease modifying anti rheumatic drugs and other molecules such as apremilast while conventional therapies included methotrexate, cyclosporine, or retinoids, phototherapy and others. The therapeutic guidelines are proposed with the aim to provide evidenced based approach to combine newer and conventional agents in day-to-day psoriasis management. Findings: Combination of acitretin and narrow band ultraviolet B (NB-UVB)/Psoralen with ultraviolet A (PUVA) achieves faster clearance and allows reduction of dose of the latter. A variable outcome is reported of methotrexate with TNF-α inhibitors vs. TNF-α inhibitors alone, although addition of methotrexate appears to reduce immunogenicity of TNF-α inhibitors thereby preventing formation of anti-drug antibodies especially in case of infliximab. While combination of acitretin and PUVA is beneficial, combining TNF-α inhibitors and phototherapy too produces better and faster results but long term risks of Non Melanoma Skin Cancers (NMSCs) may preclude their use together. Combination of cyclosporine and phototherapy is not recommended due to greater chances of NMSCs. Adding phototherapy to Fumaric Acid Esters (FAEs) improves efficacy. Apremilast can be safely combined with available biologic agents in patients with plaque psoriasis or psoriatic arthritis not responding adequately to biologics alone. Hydroxyurea and acitretin may be used together increasing their efficacy and reducing doses of both and hence their adverse effects. Conclusion: Selected clinical scenarios shall benefit from combinations therapies, improving efficacy of both conventional and newer agents and at the same time helping reduce toxicity of higher dosages when used individually.

/pdf/systematic-review-and-recommendations-to-combine-newer-1n6d47kh3j.pdf

Systematic Review and Recommendations to Combine Newer Therapies With Conventional Therapy in Psoriatic Disease.

Introduction: Psoriasis is a chronic inflammatory skin disease that waxes and wanes, and long-term remission can be difficult to achieve regardless of disease severity. Currently, numerous treatment options are available for psoriasis including steroid and non-steroid topical agents, phototherapy, oral systemic agents, and biologics, with many more therapeutic agents under development.Areas covered: This article will review various combination therapy strategies such as rotational therapy and sequential therapy and describe a variety of safe and effective combination therapies for the treatment of psoriasis. Two or more agents with different mechanisms of action and safety profiles can be used to achieve and/or maintain adequate disease control while minimizing the toxicity of treatments. Combination therapy can also be used when a single agent is not enough for treating recalcitrant disease. Choosing a combination regimen that maximizes safety and efficacy while considering patient usability and compliance can be a challenge.Expert opinion: Given the various treatment options currently available for psoriasis and more agents under development, combination therapy will continue to be a valuable treatment strategy for any patient with psoriasis. It is crucial for clinicians to carefully consider the fine balance between safety and efficacy when combining various therapeutic agents.

Safety considerations with combination therapies for psoriasis

Phosphodiesterases (PDEs) are a heterogeneous superfamily of enzymes which catalyze the degradation of the intracellular second messengers cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). Among PDEs, PDE4 is the most widely studied and characterized isoenzyme. PDE4 blocking can lead to increased levels of intracellular cAMP, which results in down-regulation of inflammatory responses by reducing the expression of tumor necrosis factor (TNF), interleukin (IL)-23, IL-17, interferon-γ, while increasing regulatory cytokines, such as IL-10. Therefore, PDE4 has been explored as a therapeutic target for the treatment of different chronic inflammatory conditions such as psoriatic arthritis (PsA) and inflammatory bowel disease (IBD). PsA shares clinical, genetic, and pathogenic features with IBD such as ulcerative colitis (UC) and Crohn’s disease (CD), and enteropathic spondyloarthritis (eSpA) represent a frequent clinical evidence of the overlap between gut and joint diseases. Current therapeutic options in PsA patients and underlying UC are limited to synthetic immunosuppressants and anti-TNF. Apremilast is an oral PDE4 inhibitor approved for the treatment of active PsA patients with inadequate response to synthetic immunosuppressants. The efficacy and a good safety profile observed in randomized clinical trials with apremilast in PsA patients have been confirmed by few studies in a real-life scenario. In addition, apremilast led to significant improvement in clinical and endoscopic features in UC patients in a phase II RCT. By now there are no available data regarding its role in eSpA patients. In view of the above, the use of apremilast in eSpA patients is a route that deserves to be deepened.

https://www.mdpi.com/1422-0067/22/5/2638/pdf

Inhibition of Phosphodiesterase-4 in Psoriatic Arthritis and Inflammatory Bowel Diseases.

Introduction Psoriasis is a chronic immune-medicated inflammatory condition that affects 2-3% of the population, which can lead to psoriatic arthritis. There are multiple regimens for the treatment of psoriasis including disease- modifying anti rheumatic drugs (DMARDS) and biologic agent, phototherapy and apremilast. While monotherapy with biologic agents is effective for many patients with psoriasis some patients are not satisfied by the outcome and require combination therapy. No data exist on the safety of apremilast as a component of combination therapy with biological therapies. Objective The aim of the study was to determine the safety of apremilast in combination of biologic therapies in the treatment of plaque psoriasis and psoriatic arthritis. Methods This was retrospective study, open label study carried out at a single community Rheumatology center. Twenty-two patients diagnosed with plaque psoriasis and psoriatic arthritis according to American college of Rheumatology criteria-participated. Apremilast was added to their current biologic agent. Patients were permitted to their current biologic treatment. Results Out of 22 patients, six patients developed side effects, none of which caused discontinuation of therapy. Out of the six patients who developed side effects, two patients developed nausea and two patients developed diarrhea. One patient developed weight loss and one patient developed abdominal pain. Conclusion Apremilast can be safely combined with all biologic agents in patients with plaque psoriasis or psoriatic arthritis not responding adequately to biologics alone.

Combination Therapy of Apremilast and Biologic Agent as a Safe Option of Psoriatic Arthritis and Psoriasis

BACKGROUND Hepatitis C virus (HCV) is a global medical health concern. Egypt has the highest HCV prevalence. Few studies have assessed the HCV prevalence rates among Egyptian-born expatriates. We sought to define the HCV prevalence Egyptian-born individuals residing in the Southern California area. PATIENTS AND METHODS We screened Egyptian-born individuals in houses of worship in the Southern California area using a point of care test HCV antibody test. Results were confirmed by testing the blood for viral load. Demographic information including risk factors were also collected. Individuals were contacted with their results, and those found to be detectable HCV antibodies were referred for further testing and additional care. RESULTS Three hundred twenty-six Egyptian expatriates from 7 houses of worship in Southern California were screened for the HCV infection. Most of the participants were screened at Coptic Churches. Nine of these individuals were found to be HCV infected (2.8%). We found an increased HCV seroprevalence in subjects were male and born in Egyptian urban areas. Five of the 9 subjects (56%) who tested positive were not baby boomers and only 2 of these 9 subjects (22%) had recognized Center for Disease Control risk factors. CONCLUSIONS The HCV prevalence rate of Egyptian-born individuals living in the Southern California area was lower compared with the prevalence rate in the general Egyptian population, but higher than that seen in the general US population. The utility of using Center for Disease Control risk factors to define individuals at risk of HCV among Egyptian expatriates is not applicable.

Hepatitis C Virus Prevalence in Egyptian Americans in Southern California.

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Combination Therapy of Apremilast and Biologic Agent as a Safe Option of Psoriatic Arthritis and Psoriasis

Hepatitis C Virus Prevalence in Egyptian Americans in Southern California.