Read by QxMD icon Read


K Reich, M Gooderham, L Green, A Bewley, Z Zhang, I Khanskaya, R M Day, J Goncalves, K Shah, V Piguet, J Soung
BACKGROUND: Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate to severe psoriasis. OBJECTIVE: Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate to severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299). METHODS: 250 patients were randomized to placebo (n=84), apremilast 30 mg BID (n=83) or etanercept 50 mg QW (n=83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104...
October 21, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Vibeke Strand, Elaine Husni, Jenny Griffith, Zheng-Yi Zhou, James Signorovitch, Arijit Ganguli
INTRODUCTION: The present study aimed to evaluate clinical outcomes and costs associated with timely versus delayed use of tumor necrosis factor inhibitors (TNFis) among patients with moderately to severely active psoriatic arthritis (PsA) with and without moderate/severe psoriasis (Ps) from a US payer's perspective. METHODS: An economic model evaluated PsA patients initially treated with a TNFi (timely TNFi use) or apremilast (delayed TNFi use). Patients without joint (American College of Rheumatology 20%, [ACR20]) improvement either switched TNFis or initiated one...
September 15, 2016: Rheumatol Ther
Jürg Hafner, Christoph Gubler, Karin Kaufmann, Stephan Nobbe, Alexander A Navarini, Lars E French
A 74-year-old woman with extensive lichen planus mucosae (LPM) developed stenotic esophagitis that was refractory to intravenous glucocorticosteroids. Esophageal dilatations to 14 mm width were repeatedly performed without any lasting effect. After introducing oral apremilast, she experienced complete clinical remission within the first 4 weeks of treatment. Control esophagoscopy confirmed a marked recovery of the esophageal mucosa with no recurrence of the former stenosis. Our observation is in line with the case series of Paul et al...
May 2016: Case Reports in Dermatology
Gary Goldenberg, Julien Lanoue, Joanna Dong
Conventional oral therapies for psoriasis, including methotrexate, cyclosporine, and acitretin, have generally unfavorable safety profiles and are not ideal for long-standing use. Thus, new oral therapies are necessary for patients with more moderate disease, patients who prefer oral treatments to injectable biologies, and patients who failed conventional therapies. The authors review here the clinical and safety evidence of phosphodiesterase 4 inhibitor, apremilast, janus kinase inhibitors, including tofacitinib, and fumarie acid esters as additional options in oral psoriasis therapy...
August 2016: Journal of Clinical and Aesthetic Dermatology
F M Perrotta, E Lubrano
Psoriatic arthritis (PsA) is a chronic inflammatory disease that possibly leads to structural damage and to a reduction of joint function and poor quality of life. Treatment of PsA has changed since its introduction of anti- TNF drugs, which have shown to reduce the symptoms and signs of the disease and slow the radiographic progression. However, recently, the discovery of new pathogenic mechanisms have made possible the development of new molecules that target pro-inflammatory cytokines involved in skin, joint and entheseal inflammation...
2016: Reumatismo
Bruce E Strober
Among the newer medications for treating psoriasis are the interleukin-17A inhibitor secukinumab and the phosphodiesterase 4 inhibitor apremilast. Secukinumab offers a level of efficacy greater than that of the tumor necrosis factor-α inhibitor adalimumab. Apremilast is associated with lower levels of efficacy than the biologic therapies for psoriasis. Apremilast may cause diarrhea and nausea and is associated with weight loss and rare instances of depression. Semin Cutan Med Surg 35(supp4):S71-S73.
June 2016: Seminars in Cutaneous Medicine and Surgery
Jacek C Szepietowski, Adam Reich
Psoriasis is a common chronic inflammatory skin disease observed in about 1-3% of the general population. About 60-90% of patients with psoriasis suffer from itching. Interestingly, in the past itch was not considered as an important symptom of psoriasis. Despite the high frequency of itch in psoriasis, the pathogenesis of this symptom is still not fully elucidated. Although most studies indicate neurogenic inflammation and the role of neuropeptides, other mediators may be important as well. The majority of psoriatic patients consider itch as the most bothersome symptom of the disease as it significantly alters daily functioning and psychosocial well-being...
2016: Current Problems in Dermatology
Meiqiong Tang, Ping Hu, Shigui Huang, Qiang Zheng, Hao Yu, Yun He
The primary objective of the present study was to develop extended-release matrix formulations of apremilast for the oral delivery and to study their in vitro and in vivo correlation. Five extended-release formulations containing hydroxypropylmethylcellulose (HPMC) as the retarding excipient with different release rate of apremilast were prepared. Dissolution tests of all the formulated tablets were performed in water, pH 4.0 and pH 6.8 buffer solutions. The in vitro release kinetics was studied and supported by Korsmeyer-Peppas's equation as it presented highest values of correlation coefficients (r(2) up to 0...
August 26, 2016: Chemical & Pharmaceutical Bulletin
D Thaçi, A Kimball, P Foley, Y Poulin, E Levi, R Chen, S R Feldman
BACKGROUND: Apremilast, an oral phosphodiesterase 4 inhibitor, has an acceptable safety profile and is effective for treatment of plaque psoriasis and psoriatic arthritis. OBJECTIVES: To evaluate the impact of apremilast on health-related quality of life (HRQOL), general functioning and mental health using patient-reported outcome (PRO) assessments among patients with moderate to severe plaque psoriasis in the ESTEEM 1 and 2 trials. METHODS: A total of 1255 patients were randomized (2 : 1) to apremilast 30 mg BID or placebo for 16 weeks; all received apremilast through Week 32...
August 18, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Miriam Bettencourt
Oral lichen planus is a very difficult condition to treat and causes patients to experience pain and difficulty eating. Therapeutic approaches focus on minimizing flares and relieving pain and discomfort to improve patient quality of life. Topical preparations are the mainstay of therapy, but they are often insufficiently efficacious for more severe cases. The use of systemic agents can be complicated by potentially serious adverse effects, the need for regular monitoring, suboptimal efficacy, and cost. Reported here are 3 recalcitrant cases of oral lichen planus that were effectively treated with apremilast, a drug recently approved for psoriasis and psoriatic arthritis...
August 1, 2016: Journal of Drugs in Dermatology: JDD
Rachael C Saporito, David J Cohen
Atopic dermatitis (AD) is a chronic, pruritic skin disease often complicated by bacterial superinfection affecting 10.7% of American children. The pathogenesis involves a skin barrier breakdown in addition to dysfunctional innate and adaptive immune response, including an unbalanced increase in T-helper 2 cells and hyperimmunoglobulinemia E. The increased numbers of T-helper 2 cells are involved in stimulating the production of immunoglobulin E and eosinophilia by releasing interleukin-4, -5, and -13 as well as in decreasing protection against bacterial superinfection by releasing interleukin-10...
May 2016: Case Reports in Dermatology
(no author information available yet)
When PUVA therapy and immunosuppressants such as methotrexate are ineffective, TNF alpha antagonists are an option for patients with severe plaque psoriasis, in the absence of a better alternative. This is also the case for patients with psoriatic arthritis after failure of a "disease-modifying" antirheumatic drug. Apremilast, an oral immunosuppressant that inhibits phosphodiesterase type 4, has been authorised in the European Union for use in these settings. In patients with plaque psoriasis, oral apremilast was compared with subcutaneous etanercept, aTNF alpha antagonist, in a randomised, doubleblind, placebo-controlled trial lasting 16 weeks and involving 250 patients in whom other treatments had failed or were inappropriate...
June 2016: Prescrire International
April W Armstrong, Keith A Betts, Murali Sundaram, Darren Thomason, James E Signorovitch
BACKGROUND: To our knowledge, no clinical trials directly compare apremilast with methotrexate (the standard of care for initial systemic treatment of psoriasis). OBJECTIVE: We sought to compare apremilast's relative efficacy with that of methotrexate for moderate to severe psoriasis. METHODS: An anchor-based indirect comparison was conducted for 75% improvement in Psoriasis Area and Severity Index score from baseline to week 16 (PASI 75) rates for systemic-naïve patients from Efficacy and Safety Trial Evaluating the Effects of apreMilast in psoriasis (ESTEEM) 1 and 2 (apremilast vs placebo) and Comparative study of HumirA vs...
October 2016: Journal of the American Academy of Dermatology
Carolyn Stull, Shoshana Grossman, Gil Yosipovitch
Pruritus is a common and significant symptom among patients with psoriasis. Pruritus is often present beyond the borders of psoriatic plaques, and frequently affects the scalp and genital regions. Psoriatic itch may be severe and can profoundly affect quality of life and sleep, even in the context of mild-to-moderate disease. These features often make the treatment of psoriatic pruritus challenging. However, there are a variety of effective topical and systemic treatment modalities available to address this symptom...
July 26, 2016: American Journal of Clinical Dermatology
Maurizio Cutolo, Gary E Myerson, Roy M Fleischmann, Frédéric Lioté, Federico Díaz-González, Filip Van den Bosch, Helena Marzo-Ortega, Eugen Feist, Kamal Shah, ChiaChi Hu, Randall M Stevens, Airi Poder
OBJECTIVE: Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy. METHODS: Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID...
September 2016: Journal of Rheumatology
Luca Bianchi, Ester Del Duca, Marco Romanelli, Rosita Saraceno, Sergio Chimenti, Andrea Chiricozzi
INTRODUCTION: Psoriasis is a chronic inflammatory skin disease affecting 2-3% of the population. Certain systemic drugs currently available for its treatment could be associated, in the long term, with organ toxicity and adverse events, thus, clinical monitoring throughout treatment is required. Moreover, tolerability issues, parenteral administration, and barriers to patient access, such as high cost and specialist management lead to treatment failure. AREAS COVERED: Apremilast is an oral small molecule inhibitor of phosphodiesterase 4 (PDE4i)...
September 2016: Expert Opinion on Drug Metabolism & Toxicology
Muzaffar Iqbal, Essam Ezzeldin, Sara Ta Al-Rashood, Faisal Imam, Khalid A Al-Rashood
BACKGROUND: Quantification of target analyte by LC-MS/MS is sometimes hampering due to competitive adduct ions formation (sodium and/or ammonium) in positive ionization mode. A UPLC-MS/MS assay was developed for the determination of apremilast in rat plasma using ESI-negative mode to avoid adduct ions formation. METHOD & RESULTS: After extraction from plasma by ethyl acetate, analyte and IS were separated on Aquity BEH C18 column using acetonitrile-10 mM ammonium acetate (85:15) as mobile phase...
June 28, 2016: Bioanalysis
Paolo Gisondi, Giampiero Girolomoni
Chronic plaque psoriasis presents clinically as an inflammatory disease of the skin, which is often associated with comorbidities and responsible for a poor quality of life. It can widely vary among patients because of different age of onset, type of symptoms, areas of involvement, and disease severity. The choice of the treatment of psoriasis should be personalized according to the specific needs of the patients. Apremilast is a well-tolerated and effective phosphodiesterase type 4 inhibitor that is indicated for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis...
2016: Drug Design, Development and Therapy
Maria Palmisano, Anfan Wu, Mahmoud Assaf, Liangang Liu, C Hyung Park, Ishani Savant, Yong Liu, Simon Zhou
OBJECTIVE: This study was conducted to evaluate the effect of apremilast and its major metabolites on the placebocorrected change-from-baseline QTc interval of an electrocardiogram (ECG). MATERIALS AND METHODS: Healthy male subjects received each of 4 treatments in a randomized, crossover manner. In the 2 active treatment periods, apremilast 30 mg (therapeutic exposure) or 50 mg (supratherapeutic exposure) was administered twice daily for 9 doses. A placebo control was used to ensure doubleblind treatment of apremilast, and an openlabel, single dose of moxifloxacin 400 mg was administered as a positive control...
August 2016: International Journal of Clinical Pharmacology and Therapeutics
Eleftherios Sideris, Mark Corbett, Stephen Palmer, Nerys Woolacott, Laura Bojke
As part of the National Institute for Health and Clinical Excellence (NICE) single technology appraisal (STA) process, the manufacturer of apremilast was invited to submit evidence for its clinical and cost effectiveness for the treatment of active psoriatic arthritis (PsA) for whom disease-modifying anti-rheumatic drugs (DMARDs) have been inadequately effective, not tolerated or contraindicated. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG)...
November 2016: PharmacoEconomics
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"