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https://www.readbyqxmd.com/read/29105621/adalimumab-etanercept-and-ustekinumab-for-treating-plaque-psoriasis-in-children-and-young-people-systematic-review-and-economic-evaluation
#1
Ana Duarte, Teumzghi Mebrahtu, Pedro Saramago Goncalves, Melissa Harden, Ruth Murphy, Stephen Palmer, Nerys Woolacott, Mark Rodgers, Claire Rothery
BACKGROUND: Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA(®), AbbVie, Maidenhead, UK), etanercept (Enbrel(®), Pfizer, New York, NY, USA) and ustekinumab (STELARA(®), Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people...
November 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29104158/moderate-salt-restriction-with-or-without-paricalcitol-in-type-2-diabetes-and-losartan-resistant-macroalbuminuria-proceed-a-randomised-double-blind-placebo-controlled-crossover-trial
#2
Aneliya Parvanova, Matias Trillini, Manuel A Podestà, Ilian Petrov Iliev, Barbara Ruggiero, Manuela Abbate, Annalisa Perna, Francesco Peraro, Olimpia Diadei, Nadia Rubis, Flavio Gaspari, Fabiola Carrara, Nadia Stucchi, Antonio Belviso, Antonio C Bossi, Roberto Trevisan, Giuseppe Remuzzi, Martin de Borst, Piero Ruggenenti
BACKGROUND: Macroalbuminuria predicts renal and cardiovascular events in patients with type 2 diabetes. We aimed to assess the albuminuria-lowering effects of salt restriction, paricalcitol therapy, or both, in this population. METHODS: In this randomised, double-blind, placebo-controlled, crossover trial, we recruited adult patients with type 2 diabetes from six diabetology outpatient clinics in northern Italy, with 24 h albuminuria of more than 300 mg despite 100 mg per day losartan therapy, blood pressure of less than 140/90 mm Hg, serum creatinine concentration of less than 2 mg/dL, stable renal function on stable renin-angiotensin system inhibitor therapy with a fixed dose of losartan, parathyroid hormone concentration of 20 pg/mL to <110 pg/mL, serum calcium concentration of less than 9·5 mg/dL, and serum phosphate concentration of less than 5 mg/dL, who had been more than 80% compliant with placebo treatment during a 1 month placebo run-in...
November 2, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29101714/changes-in-healthcare-spending-after-diagnosis-of-comorbidities-among-endometriosis-patients-a-difference-in-differences-analysis
#3
Andrew J Epstein, Ahmed M Soliman, Matthew Davis, Scott J Johnson, Michael C Snabes, Eric S Surrey
INTRODUCTION: We sought to characterize changes in healthcare spending associated with the onset of 22 endometriosis-related comorbidities. METHODS: Women aged 18-49 years with endometriosis (N = 180,278) were extracted from 2006-2015 de-identified Clinformatics(®) DataMart claims data. For 22 comorbidities, comorbidity patients were identified on the basis of having a first comorbidity diagnosis after their initial endometriosis diagnosis. Controls were identified on the basis of having no comorbidity diagnosis and were matched 1:1 to comorbidity patients on demographics and baseline spending...
November 3, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29096949/effect-of-tight-control-management-on-crohn-s-disease-calm-a-multicentre-randomised-controlled-phase-3-trial
#4
Jean-Frederic Colombel, Remo Panaccione, Peter Bossuyt, Milan Lukas, Filip Baert, Tomas Vaňásek, Ahmet Danalioglu, Gottfried Novacek, Alessandro Armuzzi, Xavier Hébuterne, Simon Travis, Silvio Danese, Walter Reinisch, William J Sandborn, Paul Rutgeerts, Daniel Hommes, Stefan Schreiber, Ezequiel Neimark, Bidan Huang, Qian Zhou, Paloma Mendez, Joel Petersson, Kori Wallace, Anne M Robinson, Roopal B Thakkar, Geert D'Haens
BACKGROUND: Biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein, have been recommended for monitoring patients with Crohn's disease, but whether their use in treatment decisions improves outcomes is unknown. We aimed to compare endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm...
October 30, 2017: Lancet
https://www.readbyqxmd.com/read/29083976/letter-corrected-net-health-benefit-calculations-for-enzalutamide-using-asco-value-framework-guidelines-and-nccn-evidence-blocks
#5
Scott Flanders, Bruce Brown, Marjan Massoudi, Neil Schultz, Krishnan Ramaswamy
This research was funded by Astellas Pharma and Medivation, which was acquired by Pfizer in 2016. Astellas Pharma and Medivation are the co-developers of enzalutamide. Flanders, Brown, Massoudi, and Schultz are employees of Astellas Pharma. Ramaswamy is an employee of Pfizer and holds stock in Johnson & Johnson. Flanders holds stock in Johnson & Johnson, AbbVie, and Abbott Labs.
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29063827/subcutaneous-injection-of-adalimumab-trial-compared-with-control-sciatic-a-randomised-controlled-trial-of-adalimumab-injection-compared-with-placebo-for-patients-receiving-physiotherapy-treatment-for-sciatica
#6
Nefyn H Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A Hughes, Eifiona Wood, Nadine E Foster, David A Walsh, Dawn Carnes, Valerie Sparkes, Elaine M Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay, Clare Wilkinson
BACKGROUND: Biological treatments such as adalimumab (Humira(®); AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29039055/treatment-patterns-complications-and-health-care-utilization-among-endometriosis-patients-undergoing-a-laparoscopy-or-a-hysterectomy-a-retrospective-claims-analysis
#7
Eric S Surrey, Ahmed M Soliman, Hongbo Yang, Ella Xiaoyan Du, Bowdoin Su
INTRODUCTION: Hysterectomy and laparoscopy are common surgical procedures used for the treatment of endometriosis. This study compares outcomes for women who received either procedure within the first year post initial surgery. METHODS: The study used data from the Truven Health MarketScan claims databases from 2004 to 2013 to identify women aged 18-49 years who received an endometriosis-related laparoscopy or hysterectomy. Patients were excluded if they did not have continuous insurance coverage from 1 year before through 1 year after their endometriosis-related procedure, if they were diagnosed with uterine fibroids prior to or on the date of surgery (i...
October 16, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29035083/multiplicity-adjusted-semiparametric-benefiting-subgroup-identification-in-clinical-trials
#8
Patrick M Schnell, Peter Müller, Qi Tang, Bradley P Carlin
Background A recent focus in the health sciences has been the development of personalized medicine, which includes determining the population for which a given treatment is effective. Due to limited data, identifying the true benefiting population is a challenging task. To tackle this difficulty, the credible subgroups approach provides a pair of bounding subgroups for the true benefiting subgroup, constructed so that one is contained by the benefiting subgroup while the other contains the benefiting subgroup with high probability...
October 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29020583/glecaprevir-and-pibrentasvir-in-patients-with-hcv-and-severe-renal-impairment
#9
MULTICENTER STUDY
Edward Gane, Eric Lawitz, David Pugatch, Georgios Papatheodoridis, Norbert Bräu, Ashley Brown, Stanislas Pol, Vincent Leroy, Marcello Persico, Christophe Moreno, Massimo Colombo, Eric M Yoshida, David R Nelson, Christine Collins, Yang Lei, Matthew Kosloski, Federico J Mensa
BACKGROUND: Chronic hepatitis C virus (HCV) infection is more prevalent among patients who have chronic kidney disease than among those who do not have the disease. Patients with chronic kidney disease who also have HCV infection are at higher risk for progression to end-stage renal disease than those who have chronic kidney disease without HCV infection. Patients with both HCV infection and advanced chronic kidney disease have limited treatment options. METHODS: We conducted a multicenter, open-label, phase 3 trial to evaluate the efficacy and safety of treatment with the combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir for 12 weeks in adults who had HCV genotype 1, 2, 3, 4, 5, or 6 infection and also had compensated liver disease (with or without cirrhosis) with severe renal impairment, dependence on dialysis, or both...
October 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28939957/effect-of-hepatitis-c-treatment-with-ombitasvir-paritaprevir-r%C3%A2-%C3%A2-dasabuvir-on-renal-cardiovascular-and-metabolic-extrahepatic-manifestations-a-post-hoc-analysis-of-phase-3-clinical-trials
#10
Darshan A Mehta, Eric Cohen, Mariem Charafeddine, Daniel E Cohen, Yanjun Bao, Yuri Sanchez Gonzalez, Tram T Tran
INTRODUCTION: We analyzed phase 3 trial data of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) ± ribavirin (RBV) in genotype 1 chronic hepatitis C patients to investigate the impact of 3D ± RBV on renal, cardiovascular and metabolic extrahepatic manifestations (EHMs), including persistency 52 weeks post treatment and differential impact by EHM disease severity. METHODS: Estimated glomerular filtration rate (eGFR), fasting triglyceride and fasting glucose values from clinical trials were used to assess renal, cardiovascular and metabolic EHMs, respectively...
September 22, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28929412/glecaprevir-pibrentasvir-first-global-approval
#11
Yvette N Lamb
A fixed-dose combination tablet of the hepatitis C virus (HCV) NS3/4A protease inhibitor (PI) glecaprevir and the HCV NS5A inhibitor pibrentasvir [glecaprevir/pibrentasvir; MAVIRET™ (EU); MAVYRET™ (USA)] has been developed by AbbVie. Oral glecaprevir/pibrentasvir 300 mg/120 mg (three 100 mg/40 mg tablets) taken once daily has been approved by the EMA for the treatment of all major genotypes (genotypes 1-6) of chronic HCV infection in adults. It has also been approved by the US FDA for the treatment of adult patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis, and for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A PI, but not both...
October 2017: Drugs
https://www.readbyqxmd.com/read/28926247/beyond-the-rule-of-5-lessons-learned-from-abbvie-s-drugs-and-compound-collection
#12
David A DeGoey, Hui-Ju Chen, Philip B Cox, Michael D Wendt
Recently, there has been an increasing focus on the pursuit of targets considered to be less-druggable that offer potential for development of promising new therapeutic agents for the treatment of diseases with large unmet medical need, particularly in the areas of oncology and virology. However, conducting drug discovery campaigns in "beyond Rule of 5" (bRo5) chemical space presents a significant drug design and development challenge to medicinal chemists to achieve acceptable oral pharmacokinetics. Retrospective analysis of past successes and failures in drug discovery bRo5 may shed light on the key principles that contribute to the oral bioavailability of successful bRo5 compounds and improve the efficiency of drug design for future projects...
September 19, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28881159/patent-trend-and-competitive-analysis-of-cancer-immunotherapy-in-the-united-states
#13
Chia-Lin Pan, Feng-Chi Chen
Immunotherapy has brought high hopes for cancer treatment, and attracted tremendous resources from the biopharmaceutical community. Here we analyze cancer immunotherapy-related patents granted by the United States Patent and Trademark Office in the past decade (2006-2016). A total of 2,229 patents were identified in 13 subfields. The growth of patent number in this field has outpaced the background rate, with cytokine-related therapies, immune checkpoint inhibitors, and natural killer cell therapies growing the most rapidly...
September 7, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28840531/long-term-effectiveness-of-adalimumab-in-patients-with-rheumatoid-arthritis-an-observational-analysis-from-the-corrona-rheumatoid-arthritis-registry
#14
Dimitrios A Pappas, Joel M Kremer, Jenny Griffith, George Reed, Bob Salim, Chitra Karki, Vishvas Garg
INTRODUCTION: Current recommendations for the management of rheumatoid arthritis (RA) focus on a treat-to-target approach with the objective of maximizing long-term health-related quality-of-life in patients with RA. Published studies from randomized clinical trials have reported limited data regarding the long-term efficacy and safety of adalimumab in patients with RA. This study aims to evaluate the long-term (10+ years) persistency and effectiveness of adalimumab in patients with RA in a real-world setting...
August 24, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28818546/glecaprevir-plus-pibrentasvir-for-chronic-hepatitis-c-virus-genotype-1-2-4-5-or-6-infection-in-adults-with-compensated-cirrhosis-expedition-1-a-single-arm-open-label-multicentre-phase-3-trial
#15
MULTICENTER STUDY
Xavier Forns, Samuel S Lee, Joaquin Valdes, Sabela Lens, Reem Ghalib, Humberto Aguilar, Franco Felizarta, Tarek Hassanein, Holger Hinrichsen, Diego Rincon, Rosa Morillas, Stefan Zeuzem, Yves Horsmans, David R Nelson, Yao Yu, Preethi Krishnan, Chih-Wei Lin, Jens J Kort, Federico J Mensa
BACKGROUND: The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis. METHODS: We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA...
October 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28815476/long-term-safety-and-effectiveness-of-adalimumab-for-moderate-to-severe-psoriasis-results-from-7-year-interim-analysis-of-the-esprit-registry
#16
Alan Menter, Diamant Thaçi, Jashin J Wu, William Abramovits, Francisco Kerdel, Dilek Arikan, Dianlin Guo, Arijit Ganguli, Mareike Bereswill, Anne Camez, Wendell C Valdecantos
INTRODUCTION: ESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term safety, effectiveness, and patient-reported outcomes (PROs) following adalimumab treatment over the first 7 years of the ESPRIT registry. METHODS: All treatment-emergent (All-TE) adverse events (AE) since the initial (first ever) dose of adalimumab were assessed...
September 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/28762213/comparative-effectiveness-of-adalimumab-versus-secukinumab-for-the-treatment-of-psoriatic-arthritis-a-matching-adjusted-indirect-comparison
#17
Vibeke Strand, Keith A Betts, Manish Mittal, Jinlin Song, Martha Skup, Avani Joshi
INTRODUCTION: The Phase III FUTURE I and II trials demonstrated the clinical efficacy of secukinumab in active psoriatic arthritis (PsA). In the absence of head-to-head trials, this study compared the clinical efficacy and cost effectiveness of adalimumab 40 mg versus secukinumab 150 and 300 mg for the treatment of active PsA. METHODS: A matching-adjusted indirect comparison was conducted using individual patient data from the ADEPT trial of adalimumab and published data from FUTURE I and II...
July 31, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28737994/impact-of-a-patient-support-program-on-patient-adherence-to-adalimumab-and-direct-medical-costs-in-crohn-s-disease-ulcerative-colitis-rheumatoid-arthritis-psoriasis-psoriatic-arthritis-and-ankylosing-spondylitis
#18
David T Rubin, Manish Mittal, Matthew Davis, Scott Johnson, Jingdong Chao, Martha Skup
BACKGROUND: AbbVie provides a free-to-patient patient support program (PSP) to assist adalimumab-treated patients with medication costs, nurse support, injection training, pen disposal, and medication reminders. The impact of these services on patient adherence to adalimumab and direct medical costs associated with autoimmune disease has not been assessed. OBJECTIVE: To quantify the relationship between participation in a PSP and outcomes (adalimumab adherence, persistence, and direct medical costs) in patients initiating adalimumab treatment...
August 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28728599/a-phase-iii-randomized-two-armed-double-blind-parallel-active-controlled-and-non-inferiority-clinical-trial-to-compare-efficacy-and-safety-of-biosimilar-adalimumab-cinnora%C3%A2-to-the-reference-product-humira%C3%A2-in-patients-with-active-rheumatoid-arthritis
#19
Ahmadreza Jamshidi, Farhad Gharibdoost, Mahdi Vojdanian, Soosan G Soroosh, Mohsen Soroush, Arman Ahmadzadeh, Mohammad Ali Nazarinia, Mohammad Mousavi, Hadi Karimzadeh, Mohammad Reza Shakibi, Zahra Rezaieyazdi, Maryam Sahebari, Asghar Hajiabbasi, Ali Asghar Ebrahimi, Najmeh Mahjourian, Amin Mohammadinejad Rashti
BACKGROUND: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). METHODS: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7...
July 20, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28702973/clinical-and-histological-changes-in-hidradenitis-suppurativa-following-1064-nm-nd-yag-intralesional-laser-treatment
#20
N Zerbinati, E D'Este, L Ini, A Baruffato, V Premoli, A Calligaro, M Paulli
Hidradenitis Suppurativa (HS) is recently attracting much attention and awareness, often because it is misdiagnosed for years, restricting the therapeutic options. Moreover, this pathology arises in areas such as the inguinal region, that may cause embarrassment in young patients. Wrong diagnosis and delay in appropriate treatments lead to an exacerbation of the symptoms and a progression of the disease, which at the last stage can only be managed through extensive surgical excisions, ablation and vaporization of nodules with CO2 laser systems or aggressive chemotherapies such as anti-TNF-alpha like adalimumab (Humira®-AbbVie Inc...
April 2017: Journal of Biological Regulators and Homeostatic Agents
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