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https://www.readbyqxmd.com/read/28881159/patent-trend-and-competitive-analysis-of-cancer-immunotherapy-in-the-united-states
#1
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
#2
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
#3
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...
August 14, 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
#4
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...
August 16, 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
#5
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
#6
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
#7
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
#8
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
https://www.readbyqxmd.com/read/28650253/diagnosis-and-treatment-of-osteoporosis-before-and-after-fracture-a-side-by-side-analysis-of-commercially-insured-and-medicare-advantage-osteoporosis-patients
#9
Jessica Weaver, Shiva Sajjan, E Michael Lewiecki, Steven T Harris
BACKGROUND: Although treatment for osteoporosis is recommended by U.S. clinical guidelines, a lack of diagnosis and treatment is common among patients with osteoporotic fractures. OBJECTIVE: To determine the rates of osteoporosis diagnosis and treatment before and after various types of fractures. METHODS: This was a retrospective claims analysis using data from the Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (Commercial group)...
July 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28650252/the-effect-of-endometriosis-symptoms-on-absenteeism-and-presenteeism-in-the-workplace-and-at-home
#10
Ahmed M Soliman, Karin S Coyne, Katharine S Gries, Jane Castelli-Haley, Michael C Snabes, Eric S Surrey
BACKGROUND: Characterized by pain symptoms, endometriosis affects women's productivity in their prime working years. OBJECTIVE: To evaluate the effect of individual endometriosis symptoms on household chore and employment productivity as measured by presenteeism and absenteeism in a population survey of women with endometriosis. METHODS: An online survey of U.S. women was conducted to evaluate the prevalence of endometriosis, as well as symptoms, demographics, and clinical characteristics of the respondents...
July 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28649691/gluten-and-aluminum-content-in-synthroid-%C3%A2-levothyroxine-sodium-tablets
#11
Ramon Espaillat, Michael F Jarvis, Cory Torkelson, Brent Sinclair
INTRODUCTION: Inquiries from healthcare providers and patients about the gluten and aluminum content of Synthroid(®) (levothyroxine sodium tablets) have increased. The objective of this study was to measure and evaluate the gluten content of the raw materials used in the manufacturing of Synthroid. Additionally, this study determined the aluminum content in different strengths of Synthroid tablets by estimating the amount of aluminum in the raw materials used in the manufacturing of Synthroid...
July 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28645740/safety-of-the-2d-3d-direct-acting-antiviral-regimen-in-hcv-induced-child-pugh-a-cirrhosis-a-pooled-analysis
#12
Fred Poordad, David R Nelson, Jordan J Feld, Michael W Fried, Heiner Wedemeyer, Lois Larsen, Daniel E Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R Foster
BACKGROUND & AIMS: Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit-risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r±DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis. METHODS: Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r±ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r+DSV±RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment...
June 21, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28644739/treatment-of-hepatitis-c-with-new-fixed-dose-combinations
#13
Vincent Soriano, José V Fernandez-Montero, Carmen de Mendoza, Laura Benitez-Gutierrez, José M Peña, Ana Arias, Pablo Barreiro
The advent of oral direct-acting antivirals (DAA) has revolutionized the hepatitis C virus (HCV) therapeutic landscape providing cure rates over 90%. However, a subset of patients remains at higher risk for treatment failure, including those infected with: i) genotype 3 and cirrhosis; ii) resistance-associated substitutions (RAS) occurring either as natural polymorphisms or selected after prior DAA failure; and iii) poor drug adherence associated with social disabilities (homeless, psychiatric illnesses, injection drug use, alcoholism, etc...
July 30, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28636480/the-emerging-role-of-pimavanserin-in-the-management-of-parkinson-s-disease-psychosis
#14
Neal Hermanowicz, Gustavo Alva, Fernando Pagan, Alberto J Espay, Amita Patel, Katya Cruz Madrid, Daniel Kremens, Jim Kenney, Sheila Arquette, Gary Tereso, Maria Lopes, Carolyn Farnum
A panel of experts drawn from neurology, psychiatry, geropsychiatry, geriatrics, and pharmacy representatives of 3 health plans convened in New York City on July 30, 2016, with the objective of sharing opinions, ideas, and information regarding the optimal management of Parkinson's disease psychosis (PDP). Three key points emerged from the discussion: (1) Because of the nature of Parkinson's disease and PDP, finding appropriate treatment can prove challenging; (2) emerging therapies may present an opportunity for effective disease management; and (3) moving forward, provider and patient education regarding PDP and available treatment options is essential for well-managed symptoms and better quality of life...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28631218/an-observational-study-of-the-effect-of-levodopa-carbidopa-intestinal-gel-on-activities-of-daily-living-and-quality-of-life-in-advanced-parkinson-s-disease-patients
#15
Rejko Krüger, Paul Lingor, Triantafyllos Doskas, Johanna M L Henselmans, Erik H Danielsen, Oriol de Fabregues, Alessandro Stefani, Sven-Christian Sensken, Juan Carlos Parra, Koray Onuk, Ashley Yegin, Angelo Antonini
INTRODUCTION: Continuous delivery of levodopa-carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson's disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations ("on" and "off" states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. METHODS: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2-4 h of "off" time or 2 h of dyskinesia daily...
July 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28603465/spinal-cord-as-an-adjunct-to-brain-magnetic-resonance-imaging-in-defining-no-evidence-of-disease-activity-in-multiple-sclerosis
#16
Subhash Tummala, Tarun Singhal, Vinit V Oommen, Gloria Kim, Fariha Khalid, Brian C Healy, Rohit Bakshi
Background: Monitoring patients with multiple sclerosis (MS) for “no evidence of disease activity” (NEDA) may help guide disease-modifying therapy (DMT) management decisions. Whereas surveillance brain magnetic resonance imaging (MRI) is common, the role of spinal cord monitoring for NEDA is unknown. Objective: To evaluate the role of brain and spinal cord 3T MRI in the 1-year evaluation of NEDA. Methods: Of 61 study patients (3 clinically isolated syndrome, 56 relapsing-remitting, 2 secondary progressive), 56 (91...
May 2017: International Journal of MS Care
https://www.readbyqxmd.com/read/28536999/randomized-phase-3-trial-of-ombitasvir-paritaprevir-ritonavir-and-ribavirin-for-hepatitis-c-virus-genotype-2-infected-japanese-patients
#17
Ken Sato, Kazuaki Chayama, Katia Alves, Hidenori Toyoda, Fumitaka Suzuki, Koji Kato, Lino Rodrigues, Xinyan Zhang, Carolyn Setze, Tami Pilot-Matias, Margaret Burroughs, Rebecca Redman, Hiromitsu Kumada
INTRODUCTION: In Japan, hepatitis C virus (HCV) genotype (GT) 2 accounts for approximately 32% of HCV infections. Limited treatment options exist in Japan for HCV GT2-infected patients. GIFT-II was a phase 3, randomized, open-label study evaluating the efficacy and safety of 16- and 12-week regimens of co-formulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus ribavirin (RBV) in Japanese adults with HCV GT2 infection. METHODS: Patients were randomized in a 1:1 ratio to once-daily, co-formulated OBV/PTV/r (25/150/100 mg) with weight-based RBV for 16 or 12 weeks...
May 23, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28525302/treatment-of-endometriosis-associated-pain-with-elagolix-an-oral-gnrh-antagonist
#18
RANDOMIZED CONTROLLED TRIAL
Hugh S Taylor, Linda C Giudice, Bruce A Lessey, Mauricio S Abrao, Jan Kotarski, David F Archer, Michael P Diamond, Eric Surrey, Neil P Johnson, Nelson B Watts, J Chris Gallagher, James A Simon, Bruce R Carr, W Paul Dmowski, Nicholas Leyland, Jean P Rowan, W Rachel Duan, Juki Ng, Brittany Schwefel, James W Thomas, Rita I Jain, Kristof Chwalisz
BACKGROUND: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. METHODS: We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain...
July 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28497757/safety-and-tolerability-of-veliparib-combined-with-capecitabine-plus-radiotherapy-in-patients-with-locally-advanced-rectal-cancer-a-phase-1b-study
#19
Brian G Czito, Dustin A Deming, Gayle S Jameson, Mary F Mulcahy, Houman Vaghefi, Matthew W Dudley, Kyle D Holen, Angela DeLuca, Rajendar K Mittapalli, Wijith Munasinghe, Lei He, John R Zalcberg, Samuel Y Ngan, Philip Komarnitsky, Michael Michael
BACKGROUND: Further optimisation of present standard chemoradiation is needed in patients with locally advanced rectal cancer. Veliparib, an oral poly(ADP-ribose) polymerase inhibitor, has been shown to enhance the antitumour activity of chemotherapy and radiotherapy in preclinical models. We aimed to establish the maximum tolerated dose and establish the recommended phase 2 dose of veliparib combined with neoadjuvant capecitabine and radiotherapy. METHODS: This phase 1b, open-label, multicentre, dose-escalation study was done at six hospitals (one in Australia and five in the USA)...
June 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28478975/efficacy-and-safety-of-adalimumab-every-other-week-versus-methotrexate-once-weekly-in-children-and-adolescents-with-severe-chronic-plaque-psoriasis-a-randomised-double-blind-phase-3-trial
#20
Kim Papp, Diamant Thaçi, Danielle Marcoux, Lisa Weibel, Sandra Philipp, Pierre-Dominique Ghislain, Ian Landells, Peter Hoeger, Carol Kotkin, Kristina Unnebrink, Marieke Seyger, David Williams
BACKGROUND: Adalimumab is indicated for the treatment of moderate to severe psoriasis in adults. We assessed the efficacy and safety of adalimumab in children and adolescents with severe plaque psoriasis. METHODS: This randomised, double-blind, multiperiod, phase 3 trial was done at 38 clinics in 13 countries. Patients (aged ≥4 to <18 years) with severe plaque psoriasis who had not responded to topical therapy were randomly assigned with an interactive voice or web-response system (1:1:1) to receive adalimumab 0·8 mg/kg or 0·4 mg/kg subcutaneously at week 0, then every other week starting at week 1, or oral methotrexate once weekly (0·1-0·4 mg/kg) for 16 weeks...
July 1, 2017: Lancet
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