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Apremilast

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https://www.readbyqxmd.com/read/28416342/long-term-safety-and-tolerability-of-apremilast-in-patients-with-psoriasis-pooled-safety-analysis-for-%C3%A2-156%C3%A2-weeks-from-2-phase-3-randomized-controlled-trials-esteem-1-and-2
#1
Jeffrey Crowley, Diamant Thaçi, Pascal Joly, Ketty Peris, Kim A Papp, Joana Goncalves, Robert M Day, Rongdean Chen, Kamal Shah, Carlos Ferrándiz, Jennifer C Cather
BACKGROUND: Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. OBJECTIVE: Assess long-term safety of oral apremilast in psoriasis patients. METHODS: Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2. RESULTS: The 0 to ≥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902...
April 14, 2017: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28400896/treatment-of-recalcitrant-erosive-oral-lichen-planus-and-desquamative-gingivitis-with-oral-apremilast
#2
Mohn'd AbuHilal, Scott Walsh, Neil Shear
BACKGROUND: Erosive oral lichen planus and desquamative gingivitis are uncommon but severe debilitating variants of oral lichen planus. Treatment of these presentations is difficult and challenging. MAIN OBSERVATION: A 44-year-old woman was referred to the dermatology clinic with chronic painful lichen planus-related gingivitis and buccal erosions. She has failed multiple treatments including topical clobetasol and tacrolimus, intralesional corticosteroids and several systemic and immunosuppressive agents...
November 30, 2016: Journal of Dermatological Case Reports
https://www.readbyqxmd.com/read/28391657/apremilast-an-oral-phosphodiesterase-4-inhibitor-in-the-treatment-of-japanese-patients-with-moderate-to-severe-plaque-psoriasis-efficacy-safety-and-tolerability-results-from-a-phase-2b-randomized-controlled-trial
#3
Mamitaro Ohtsuki, Yukari Okubo, Mayumi Komine, Shinichi Imafuku, Robert M Day, Peng Chen, Rosemary Petric, Allan Maroli, Osamu Nemoto
Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, works intracellularly within immune cells to regulate inflammatory mediators. This phase 2b randomized, placebo-controlled study evaluated efficacy and safety of apremilast among Japanese patients with moderate to severe plaque psoriasis. In total, 254 patients were randomized to placebo, apremilast 20 mg b.i.d. (apremilast 20) or apremilast 30 mg b.i.d. (apremilast 30) through week 16; thereafter, all placebo patients were re-randomized to apremilast 20 or 30 through week 68...
April 9, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28380251/apremilast-and-suicidality-a-retrospective-analysis-of-three-large-databases-the-faers-eudravigilance-and-a-large-single-center-u-s-patient-population
#4
P P Vakharia, K A Orrell, D Lee, S M Rangel, E Lund, A E Laumann, B Nardone
Apremilast is a small molecule phosphodiesterase-4 inhibitor approved by the United States Food and Drug Administration (FDA) in 2014 for the treatment of adult patients with moderate-to-severe plaque psoriasis and for psoriatic arthritis.(1) Worsening depression, suicide attempts, suicidal ideation, and suicidal behavior have previously been reported in clinical trials and post-marketing surveillance data, and details are included in the Full Prescribing Information.(1) Moreover, a post-marketing statement recently issued now indicates that completed suicide has also been reported...
April 5, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28378713/the-preparation-characterization-structure-and-dissolution-analysis-of-apremilast-solvatomorphs
#5
Yun Deng Wu, Xiao Lei Zhang, Xiao Hong Liu, Jian Xu, Mei Zhang, Kun Shen, Si Han Zhang, Yong Mei He, Yan Ma, Ai Hua Zhang
Apremilast (AP) {systematic name: (S)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-4-acetamidoisoindoline-1,3-dione} is an inhibitor of phosphodieasterase-4 (PDE4) and is indicated for the treatment of adult patients with active psoriatic arthritis. The ability of AP to form solvates has been investigated and three solvatomorphs of AP, namely, the AP ethyl acetate hemisolvate, C22H24N2O7S·0.5C4H8O2, the AP toluene hemisolvate, C22H24N2O7S·0.5C7H8, and the AP dichloromethane monosolvate, C22H24N2O7S·CH2Cl2, were obtained...
April 1, 2017: Acta Crystallographica. Section C, Structural Chemistry
https://www.readbyqxmd.com/read/28359817/solubility-and-thermodynamics-of-apremilast-in-different-mono-solvents-determination-correlation-and-molecular-interactions
#6
Faiyaz Shakeel, Nazrul Haq, Fars K Alanazi, Ibrahim A Alsarra
The solubility data of recently launched poorly soluble antipsoriatic drug apremilast (APM) in any mono solvent or cosolvent mixtures with respect to temperature are not available in literature. Hence, in this research work, the solubility of APM in twelve different mono solvents namely "water, methanol, ethanol, isopropanol (IPA), ethylene glycol (EG), propylene glycol (PG), 1-butanol, 2-butanol, ethyl acetate (EA), dimethyl sulfoxide (DMSO), polyethylene glycol-400 (PEG-400) and Transcutol(®)" was determined at temperatures "T=298...
March 28, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28329487/apremilast-for-the-treatment-of-psoriatic-arthritis
#7
Brent C Martin, Logan W Thomas, Francis J Dann
Psoriatic arthritis (PsA) is a chronic inflammatoryarthropathy that affects joints and entheses andis associated with psoriasis (PsO). There are fiveclinical patterns of PsA: symmetrical polyarthritis,distal interphalangeal arthropathy, asymmetricaloligoarthritis, arthritis mutilans, and spondylitis, withor without sacroiliitis. Concerning PsA, the goals oftherapy are to control inflammation, prevent articulardamage, and reduce discomfort in the affected joints.Although there are many therapeutic options forthe treatment of PsAs, physicians most often beginwith nonsteroidal anti-inflammatory drugs (NSAIDs)for mild disease...
February 15, 2017: Dermatology Online Journal
https://www.readbyqxmd.com/read/28329479/apremilast-for-treatment-of-recurrent-erythema-multiforme
#8
Tinley Chen, Jacob Levitt, Lauren Geller
Recurrent erythema multiforme with oralinvolvement is therapeutically challenging.Apremilast has been used with success in resolvingthe oral aphthae of Behçet disease, prompting theuse of the drug in patients with oral erosions fromerythema multiforme. Three patients with oralerythema multiforme were given apremilast at dosesof 30-60mg daily. Complete clearance of the lesionswere observed in all three patients, including thoserefractory to other standard therapies. Apremilast maypresent an effective option for recurrent erythemamultiforme for patients who have failed trials antiviraland immunosuppressive therapies...
January 15, 2017: Dermatology Online Journal
https://www.readbyqxmd.com/read/28300857/evaluation-of-the-physician-global-assessment-and-body-surface-area-composite-tool-for-assessing-psoriasis-response-to-apremilast-therapy-results-from-esteem-1-and-esteem-2
#9
Kristina C Duffin, Kim A Papp, Jerry Bagel, Eugenia Levi, Rongdean Chen, Alice B Gottlieb
BACKGROUND: The Physician Global Assessment and Body Surface Area (PGAxBSA) composite tool is a simple, effective alternative for measuring psoriasis severity. OBJECTIVE: To evaluate the product of PGAxBSA as a sensitive alternative to the Psoriasis Area and Severity Index (PASI) for assessing disease severity and therapeutic response with data collected from the phase 3 ESTEEM 1 and 2 trials. METHODS: This post hoc analysis included 836 patients randomized to apremilast 30 mg BID at baseline (ESTEEM 1, n=562; ESTEEM 2, n=274)...
February 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28276777/apremilast-for-the-management-of-moderate-to-severe-plaque-psoriasis
#10
REVIEW
Ramya Vangipuram, Ali Alikhan
Psoriasis is a chronic inflammatory skin disease characterized by erythematous plaques on extensor surfaces, scalp, and back. Current therapies for psoriasis are limited by route of administration, side effects, and cost. Apremilast is the first oral phosphodiesterase inhibitor approved for moderate-to-severe plaque psoriasis. It is a small molecule inhibitor of phosphodiesterase-4, and decreases the inflammatory activity associated with psoriasis. Areas covered: This review will discuss the pharmacology of apremilast, mechanism of action, results from key clinical trials, and its use in managing psoriasis...
April 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28255338/apremilast-in-the-treatment-of-psoriatic-arthritis-a-perspective-review
#11
REVIEW
Michael Reed, David Crosbie
Apremilast is an orally-active small molecule which inhibits phosphodiesterase-4 (PDE4). Clinical trials have demonstrated its efficacy and safety in psoriatic arthritis (PsA) and psoriasis. Established therapeutic options have variable effectiveness across the different domains of psoriatic disease. Whilst biologic therapies have proven to be of significant benefit to many patients, not all patients respond, and others are not eligible or do not tolerate biologic therapy. We review the mechanism of action, pharmacokinetics and clinical trial data with regards to both efficacy and safety for apremilast and consider where this new treatment may be positioned in the treatment of PsA...
February 2017: Therapeutic Advances in Musculoskeletal Disease
https://www.readbyqxmd.com/read/28242628/dtb-select-3-march-2017
#12
(no author information available yet)
Potential for abuse and misuse of pregabalin and gabapentin | Risk of depression and suicidal thoughts with ▼apremilast | Are patients overly optimistic about outcomes? | Pioglitazone and cardiovascular outcomes | Antipsychotics and risk of acute respiratory failure in patients with COPD | Improving adherence to lipid-lowering drugs | ▼Canagliflozin associated with increased risk of amputation | Medical research news stories: how independent and qualified are commenters?
February 27, 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28239890/successful-treatment-of-refractory-palmoplantar-pustulosis-with-apremilast
#13
G Haebich, M Kalavala
No abstract text is available yet for this article.
February 27, 2017: Clinical and Experimental Dermatology
https://www.readbyqxmd.com/read/28238463/-apremilast-beware-of-suicidal-ideation-and-behaviour
#14
J-L Schmutz
No abstract text is available yet for this article.
March 2017: Annales de Dermatologie et de Vénéréologie
https://www.readbyqxmd.com/read/28213862/apremilast-a-review-in-psoriasis-and-psoriatic-arthritis
#15
Gillian M Keating
Apremilast (Otezla(®)) is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast 30 mg twice daily reduced the severity of moderate to severe plaque psoriasis in the phase 3 ESTEEM trials, as well as improving difficult-to-treat nail, scalp and palmoplantar psoriasis. Most patient-reported outcomes, including pruritus and the total Dermatology Life Quality Index, also improved to a significantly greater extent with apremilast than with placebo, with significant improvements in pruritus and skin discomfort/pain visual analogue scale scores seen as early as week 2 with apremilast...
March 2017: Drugs
https://www.readbyqxmd.com/read/28209630/inhibition-of-phosphodiesterase-4-pde4-reduces-dermal-fibrosis-by-interfering-with-the-release-of-interleukin-6-from-m2-macrophages
#16
Christiane Maier, Andreas Ramming, Christina Bergmann, Rita Weinkam, Nicolai Kittan, Georg Schett, Jörg H W Distler, Christian Beyer
OBJECTIVES: To investigate the disease-modifying effects of phosphodiesterase 4 (PDE4) inhibition in preclinical models of systemic sclerosis (SSc). METHODS: We studied the effects of PDE4 inhibition in a prevention and a treatment model of bleomycin-induced skin fibrosis, in the topoisomerase mouse model as well as in a model of sclerodermatous chronic graft-versus-host disease. To better understand the mode of action of PDE4 blockade in preclinical models of SSc, we investigated fibrosis-relevant mediators in fibroblasts and macrophages from healthy individuals and patients suffering from diffuse-cutaneous SSc on blockade of PDE4...
February 16, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28197884/therapies-of-early-advanced-and-late-onset-forms-of-axial-spondyloarthritis-and-the-need-for-treat-to-target-strategies
#17
REVIEW
Nurullah Akkoc, Gercek Can, Salvatore D'Angelo, Angela Padula, Ignazio Olivieri
PURPOSE OF REVIEW: This study aims to provide an update on current status of pharmacological therapies in early and advanced stages of axial spondyloarthritis (axSpA), as well as its late onset forms, and to discuss the need for treat to target strategies in this entity. RECENT FINDINGS: Efficacy of TNF inhibitors has been assessed in randomized controlled trials in axSpA, which included patients who had non-radiographic axSpA according to the ASAS classification criteria...
February 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28176964/efficacy-and-safety-of-biological-and-targeted-synthetic-dmards-a-systematic-literature-review-informing-the-2016-update-of-the-asas-eular-recommendations-for-the-management-of-axial-spondyloarthritis
#18
Alexandre Sepriano, Andrea Regel, Désirée van der Heijde, Jürgen Braun, Xenofon Baraliakos, Robert Landewé, Filip Van den Bosch, Louise Falzon, Sofia Ramiro
OBJECTIVES: To update the evidence for the efficacy and safety of (b)biological and (ts)targeted-synthetic disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League Against Rheumatism (ASAS/EULAR) recommendations for the management of axSpA. METHODS: Systematic literature review (2009-2016) for randomised controlled trials (RCT), including long-term extensions, strategy trials and observational studies (the latter was only for safety assessment and a comparator was required)...
2017: RMD Open
https://www.readbyqxmd.com/read/28144028/current-and-emerging-therapeutic-targets-for-ibd
#19
REVIEW
Markus F Neurath
Various therapeutic advances have led to a paradigm shift in the clinical management of patients with IBD. The introduction of immunosuppressive (such as azathioprine) and biologic agents (such as TNF blockers) has markedly reduced the need to use corticosteroids for therapy. Furthermore, the α4β7 integrin blocker vedolizumab has been introduced for clinical IBD therapy. Moreover, various new inhibitors of cytokines (for example, IL-6-IL-6R and IL-12-IL-23 blockers or apremilast), modulators of cytokine signalling events (for example, JAK inhibitors or SMAD7 blocker), inhibitors of transcription factors (for example, GATA3 or RORγt) and new anti-adhesion and anti-T-cell-activation and migration strategies (for example, β7 integrin, sphingosine 1-phosphate receptors and MAdCAM1 inhibitors, regulatory T-cell therapy and stem cells) are currently being evaluated in controlled clinical trials...
February 1, 2017: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28132578/safety-evaluation-of-apremilast-for-the-treatment-of-psoriasis
#20
A Dattola, E Del Duca, R Saraceno, T Gramiccia, L Bianchi
Psoriasis (PSo) is a chronic inflammatory skin disease associated with co-morbidities such as hypertension, diabetes, dyslipidemia and metabolic syndrome. It is a typothypical Th1/Th17 disease that affects from 2 to 3% of the world population. Numerous are the drugs that can be used in our clinical practice; the choice of these drugs depends on the characteristics of the patient. Areas covered: Apremilast is the first oral small molecules to receive FDA approval for the treatment of adults with active psoriasis and psoriatic arthritis...
March 2017: Expert Opinion on Drug Safety
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