Read by QxMD icon Read


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
Peter Nash, Johan Vanhoof, Stephen Hall, Udayasankar Arulmani, Rita Tarzynski-Potempa, Kristina Unnebrink, Andrew N Payne, Alfred Cividino
INTRODUCTION: Adalimumab, an anti-tumor necrosis factor antibody, is currently available in a 40 mg/0.8 mL formulation. The objective of this analysis was to evaluate injection site-related pain, safety, and tolerability of a 40 mg/0.4 mL formulation of adalimumab that had fewer excipients, a smaller volume, and a delivery presentation with a smaller gauge needle, versus the current 40 mg/0.8 mL formulation in patients with rheumatoid arthritis (RA). METHODS: Two identically designed, phase 2, randomized, single-blind, two-period crossover studies were conducted in Belgium and the Czech Republic (Study 1) and Australia, Canada, and Germany (Study 2)...
August 18, 2016: Rheumatol Ther
Keith A Betts, Jenny Griffith, Yan Song, Manish Mittal, Avani Joshi, Eric Q Wu, Arijit Ganguli
INTRODUCTION: Biologic therapies have improved the clinical management of ankylosing spondylitis (AS). Few head-to-head studies have directly compared the efficacy of these agents. This study was conducted to indirectly compare the efficacy of biologic agents for treatment of active AS. METHODS: A targeted literature review was conducted to identify randomized clinical trials for adalimumab, infliximab, golimumab, certolizumab pegol, etanercept, and secukinumab for the treatment of active AS...
July 25, 2016: Rheumatol Ther
Takao Koike, Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Syuji Takei, Tsutomu Takeuchi, Hisashi Yamanaka, Yoshinari Takasaki, Tsuneyo Mimori, Katsutoshi Hiramatsu, Shuichi Komatsu, Yoshiya Tanaka
INTRODUCTION: There is insufficient evidence regarding the appropriate dose of methotrexate (MTX) required to achieve specific treatment goals in patients with rheumatoid arthritis (RA) receiving biologic drugs in Japan. The present study aimed to assess the dose-response effect of MTX in combination with adalimumab (ADA) to achieve low disease activity (LDA) and/or remission at 24 weeks in RA patients. METHODS: This analysis used data of the ADA all-case survey in Japan (n = 7740), and 5494 patients who received ADA and MTX were classified into five groups by weighted average MTX dose (>0-<4, 4-<6, 6-<8, 8-< 10, and ≥10 mg/week)...
June 2016: Rheumatol Ther
Symon Gathiaka, Shuai Liu, Michael Chiu, Huanwang Yang, Jeanne A Stuckey, You Na Kang, Jim Delproposto, Ginger Kubish, James B Dunbar, Heather A Carlson, Stephen K Burley, W Patrick Walters, Rommie E Amaro, Victoria A Feher, Michael K Gilson
The Drug Design Data Resource (D3R) ran Grand Challenge 2015 between September 2015 and February 2016. Two targets served as the framework to test community docking and scoring methods: (1) HSP90, donated by AbbVie and the Community Structure Activity Resource (CSAR), and (2) MAP4K4, donated by Genentech. The challenges for both target datasets were conducted in two stages, with the first stage testing pose predictions and the capacity to rank compounds by affinity with minimal structural data; and the second stage testing methods for ranking compounds with knowledge of at least a subset of the ligand-protein poses...
September 30, 2016: Journal of Computer-aided Molecular Design
Mark L Montgomery, Noel K Miner, Michael J Soileau, Douglas K McDonald
The primary treatment for Parkinson's disease is dopaminergic stimulation. Although levodopa has historically been administered orally, maintaining a predictable plasma concentration of the drug is challenging. As a result, enteral administration of carbidopa/levodopa (Duopa) has emerged as a promising tool in the treatment of the disease. This requires placement of an enteric catheter, two of which have been approved by the Food and Drug Administration for delivery of Duopa. The approved tubes are placed using the "peroral" or "pull" technique, a method traditionally requiring endoscopy...
October 2016: Proceedings of the Baylor University Medical Center
Ting Song, Ziqian Wang, Zhichao Zhang
The myeloid cell leukemia 1 (Mcl-1) protein, an anti-apoptotic member of Bcl-2 family, plays a critical role in the development and maintenance of many cancers and is listed in the 'top ten' pathological factors across the diversity of human cancers. The patent described in this evaluation (WO2015148854A1) claimed substituted indole Mcl-1 inhibitors for the treatment of diseases and conditions (e.g., cancer) characterized by the over-expression or dysregulation of Mcl-1 proteins. A variety of 2-position substituents distinguished indole Mcl-1 inhibitors claimed in this patent from another two patents by AbbVie Inc...
October 4, 2016: Expert Opinion on Therapeutic Patents
Kaoru Yokoyama, Kiyotaka Yamazaki, Miiko Katafuchi, Sameh Ferchichi
INTRODUCTION: Crohn's disease (CD) is a chronic and progressive disease in which the long-term management is important. This study sought to assess treatment persistence and dose escalation in the maintenance phase with adalimumab (ADA) or infliximab (IFX) in a Japanese real-world setting. METHODS: A retrospective analysis was conducted using the Japan Medical Data Center database. CD patients with either ADA or IFX prescriptions between January 2012 and February 2015 were included...
September 23, 2016: Advances in Therapy
Susan O'Brien, Jeffrey A Jones, Steven E Coutre, Anthony R Mato, Peter Hillmen, Constantine Tam, Anders Österborg, Tanya Siddiqi, Michael J Thirman, Richard R Furman, Osman Ilhan, Michael J Keating, Timothy G Call, Jennifer R Brown, Michelle Stevens-Brogan, Yunfeng Li, Fong Clow, Danelle F James, Alvina D Chu, Michael Hallek, Stephan Stilgenbauer
BACKGROUND: The TP53 gene, encoding tumour suppressor protein p53, is located on the short arm of chromosome 17 (17p). Patients with 17p deletion (del17p) chronic lymphocytic leukaemia have poor responses and survival after chemoimmunotherapy. We assessed the activity and safety of ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase, in relapsed or refractory patients with del17p chronic lymphocytic leukaemia or small lymphocytic lymphoma. METHODS: We did a multicentre, international, open-label, single-arm study at 40 sites in the USA, Canada, Europe, Australia, and New Zealand...
October 2016: Lancet Oncology
Josep Figueras-Aloy, Paolo Manzoni, Bosco Paes, Eric A F Simões, Louis Bont, Paul A Checchia, Brigitte Fauroux, Xavier Carbonell-Estrany
INTRODUCTION: The REGAL (RSV Evidence-a Geographical Archive of the Literature) series provide a comprehensive review of the published evidence in the field of respiratory syncytial virus (RSV) in Western countries over the last 20 years. This second publication covers the risk and burden of RSV infection in preterm infants born at <37 weeks' gestational age (wGA) without chronic lung disease or congenital heart disease. METHODS: A systematic review was undertaken for articles published between January 1, 1995 and December 31, 2015...
September 14, 2016: Infectious Diseases and Therapy
Glenn J Jaffe, Andrew D Dick, Antoine P Brézin, Quan Dong Nguyen, Jennifer E Thorne, Philippe Kestelyn, Talin Barisani-Asenbauer, Pablo Franco, Arnd Heiligenhaus, David Scales, David S Chu, Anne Camez, Nisha V Kwatra, Alexandra P Song, Martina Kron, Samir Tari, Eric B Suhler
Background Patients with noninfectious uveitis are at risk for long-term complications of uncontrolled inflammation, as well as for the adverse effects of long-term glucocorticoid therapy. We conducted a trial to assess the efficacy and safety of adalimumab as a glucocorticoid-sparing agent for the treatment of noninfectious uveitis. Methods This multinational phase 3 trial involved adults who had active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite having received prednisone treatment for 2 or more weeks...
September 8, 2016: New England Journal of Medicine
Aaron Spitz, Marc Gittelman, Lawrence I Karsh, Sanja Dragnic, Ahmed M Soliman, Aditya Lele, Damian Gruca, Michael Norton
INTRODUCTION: Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) analogs is a standard treatment for advanced prostate cancer. GnRH analog therapy can reduce testosterone to "castrate" levels, historically defined as <50 ng/dL. With the advent of newer assays, a lower threshold of <20 ng/dL has recently been proposed. We report the results of a retrospective analysis of two Phase III trials of 4- and 6-month depot microsphere formulations of leuprolide acetate (LA), a GnRH agonist that has previously demonstrated efficacy in testosterone suppression to <50 ng/dL in patients on ADT...
2016: Research and Reports in Urology
Quan Dong Nguyen, Pauline T Merrill, Glenn J Jaffe, Andrew D Dick, Shree Kumar Kurup, John Sheppard, Ariel Schlaen, Carlos Pavesio, Luca Cimino, Joachim Van Calster, Anne A Camez, Nisha V Kwatra, Alexandra P Song, Martina Kron, Samir Tari, Antoine P Brézin
BACKGROUND: Non-infectious uveitis is a potentially sight-threatening ocular disorder caused by chronic inflammation and its complications. Therapeutic success is limited by systemic adverse effects associated with long-term corticosteroid and immunomodulator use if topical medication is not sufficient to control the inflammation. We aimed to assess the efficacy and safety of adalimumab in patients with inactive, non-infectious uveitis controlled by systemic corticosteroids. METHODS: We did this multicentre, double-masked, randomised, placebo-controlled phase 3 trial at 62 study sites in 21 countries in the USA, Canada, Europe, Israel, Australia, and Latin America...
September 17, 2016: Lancet
Mette R Rosberg, Susana Alvarez, Christian Krarup, Mihai Moldovan
Mice deficient of myelin protein P0 are established models of demyelinating Charcot-Marie-Tooth (CMT) disease. Dysmyelination in these mice is associated with an ectopic expression of the sensory neuron specific sodium channel isoform NaV1.8 on motor axons. We reported that in P0+/-, a model of CMT1B, the membrane dysfunction could be acutely improved by a novel oral NaV1.8 blocker referred to as Compound 31 (C31, Bioorg. Med. Chem. Lett. 2010, 20, 6812; AbbVie Inc.). The aim of this study was to investigate the extent to which C31 treatment could also improve the motor axon function in P0-/-, a CMT model with a much more severe neuropathy...
October 6, 2016: Neuroscience Letters
Alexa B Kimball, Martin M Okun, David A Williams, Alice B Gottlieb, Kim A Papp, Christos C Zouboulis, April W Armstrong, Francisco Kerdel, Michael H Gold, Seth B Forman, Neil J Korman, Evangelos J Giamarellos-Bourboulis, Jeffrey J Crowley, Charles Lynde, Ziad Reguiai, Errol-Prospero Prens, Eihab Alwawi, Nael M Mostafa, Brett Pinsky, Murali Sundaram, Yihua Gu, Dawn M Carlson, Gregor B E Jemec
BACKGROUND: Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor α, showed efficacy against hidradenitis suppurativa. METHODS: PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled periods. In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks...
August 4, 2016: New England Journal of Medicine
James G Stevenson, Larry Green
UNLABELLED: The most appropriate naming convention for biologics and biosimilars has been an area of significant debate. The ultimate decision will have an impact on patient safety, pharmacovigilance program effectiveness, and, potentially, the overall adoption of biosimilars in the United States. This article reviews some of the advantages and disadvantages of various naming approaches. For clarity in communication, optimal pharmacovigilance, and patient safety, it is recommended that biosimilars be named with a common USAN (United States Adopted Name) with the reference product, along with a suffix that is memorable, such as one associated with the original manufacturer of the product...
August 2016: Journal of Managed Care & Specialty Pharmacy
Robert B Zurier, Sumner H Burstein
Cannabinoids apparently act on inflammation through mechanisms different from those of agents such as nonsteroidal anti-inflammatory drugs (NSAIDs). As a class, the cannabinoids are generally free from the adverse effects associated with NSAIDs. Their clinical development thus provides a new approach to treatment of diseases characterized by acute and chronic inflammation and fibrosis. A concise survey of the anti-inflammatory actions of the phytocannabinoids Δ(9)-tetrahydrocannabinol (THC), cannabidiol, cannabichromene, and cannabinol is presented...
July 19, 2016: FASEB Journal: Official Publication of the Federation of American Societies for Experimental Biology
Ralf Gold, Dusan Stefoski, Krzysztof Selmaj, Eva Havrdova, Christopher Hurst, Joan Holman, Belen Tornesi, Surekha Akella, Peter McCroskery
INTRODUCTION: Multiple sclerosis (MS) is more common in women and can occur during childbearing years; thus, information on outcomes following exposure to MS therapy during pregnancy is important. No formal studies of daclizumab have been conducted in pregnant women. Here, we report available nonclinical and clinical data on pregnancy outcomes from the daclizumab clinical study program. METHODS: Reproductive and developmental toxicity studies were conducted in cynomolgus monkeys...
July 13, 2016: Neurology and Therapy
Nanette Santoro, Esther Eisenberg, J C Trussell, LaTasha B Craig, Clarisa Gracia, Hao Huang, Ruben Alvero, Peter Casson, Gregory Christman, Christos Coutifaris, Michael Diamond, Susan Jin, Richard S Legro, Randal D Robinson, William D Schlaff, Heping Zhang
STUDY QUESTION: Does fertility-related quality of life (FertiQOL) differ by infertility diagnosis between women with polycystic ovary syndrome (PCOS) and their partners, compared with couples with unexplained infertility (UI)? SUMMARY ANSWER: Women with PCOS report lower QOL than those with UI, whereas males with UI report lower QOL than males with PCOS partners. WHAT IS KNOWN ALREADY: The fertility-specific QOL survey, FertiQOL, has been used to examine fertility-related QOL in a number of worldwide cohorts...
October 2016: Human Reproduction
Grace Huang, Whitney Wharton, Shalender Bhasin, S Mitchell Harman, Karol M Pencina, Panayiotis Tsitouras, Zhuoying Li, Kathleen A Hally, Sanjay Asthana, Thomas W Storer, Shehzad Basaria
BACKGROUND: The effects of testosterone on cognitive function in older men are incompletely understood. We aimed to establish the effects of long-term testosterone administration on multiple domains of cognitive function in older men with low or low-to-normal testosterone concentrations. METHODS: We did the randomised, double-blind, placebo-controlled, parallel-group TEAAM trial at three medical centres in Boston, Phoenix, and Los Angeles, USA. Men aged 60 years and older with low or low-to-normal testosterone concentrations (3·47-13·9 nmol/L, or free testosterone <173 pmol/L) were randomly assigned (1:1), via computer-generated randomisation, to receive either 7·5 g of 1% testosterone gel or placebo gel daily for 3 years...
August 2016: Lancet Diabetes & Endocrinology
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"