- |||||||||| Humira (adalimumab) / Eisai, AbbVie
Clinical, Journal: Performance of Crohn's disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data. (Pubmed Central) - Jun 7, 2019 ...This post hoc analysis of data fromEXTEND (extend the safety and efficacy of adalimumab through endoscopic healing), a placebo (PBO)-controlled, randomized trial of adalimumab (ADA) for mucosal healing, included adults with moderate-to-severe CD...Site-based evaluation was associated with lower remission rates versus central reading in the PBO group and, thus, greater ADA-related treatment effects. This analysis is the first to demonstrate that increasing the stringency of clinical and endoscopic endpoint definitions in CD trials, especially lowering SF or SES-CD definitions, reduces the ability to detect treatment-related change in CD activity; focus on endpoints that reflect clinical change is warranted.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie
Journal, HEOR: Cost-effectiveness of different treat-to-target strategies in rheumatoid arthritis: results from the DREAM registry. (Pubmed Central) - Jun 7, 2019 ...However, not much is known about long-term cost-effectiveness of different T2T strategies.We model the 5-year costs and effects of a step-up approach (MTX mono - > MTX + csDMARD combination - > Adalimumab - > second anti-TNF) and an initial combination therapy approach (MTX + csDMARD - > MTX + csDMARD higher dose - > anti-TNFs) from the healthcare and societal perspectives, by adapting a previously validated Markov model...Initial combination therapy was found favourable over step-up therapy in the treatment of Rheumatoid Arthritis, when considering cost-effectiveness. Initial combination therapy resulted in more utility at a lower cost over 5 years.
- |||||||||| Clinical, Journal: The use of leukocytes' secretome to individually target biological therapy in autoimmune arthritis: a case report. (Pubmed Central) - Jun 6, 2019
This study demonstrates that higher maintenance adalimumab concentrations are associated with objective therapeutic outcomes in IBD. An efficient way to effectively treat patients with complex autoimmune arthropathies, and avoid irreversible disability, is to know their leukocytes' secretome to identify abnormally secreted cytokines and personalize their biotherapy, as exemplified by this case report.
- |||||||||| Clinical, Journal, HEOR: Comparing biologic persistence and healthcare costs in rheumatoid arthritis patients initiating subcutaneous biologics. (Pubmed Central) - Jun 5, 2019
An efficient way to effectively treat patients with complex autoimmune arthropathies, and avoid irreversible disability, is to know their leukocytes' secretome to identify abnormally secreted cytokines and personalize their biotherapy, as exemplified by this case report. Abatacept-treated RA patients appeared to have the poorest health status yet often had the lowest increase from baseline in healthcare costs and longest duration of biologic persistence.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Entyvio (vedolizumab) / Takeda, Humira (adalimumab) / Eisai, AbbVie
Clinical, PK/PD data, Journal: Safety, efficacy and pharmacokinetics of vedolizumab in patients with simultaneous exposure to an anti-tumour necrosis factor. (Pubmed Central) - Jun 5, 2019 Vedolizumab/anti-TNF co-exposure did not generate new safety signals during 14-weeks induction, nor did it reduce efficacy or alter vedolizumab pharmacokinetics. These observations may aid the design of future co-biologics trials and also suggest that a deliberate waiting-interval between anti-TNF cessation and subsequent vedolizumab initiation may not be warranted.
- |||||||||| Avastin (bevacizumab) / Roche, Humira (adalimumab) / Eisai, AbbVie
Journal: A novel online four-dimensional SECxSEC-IMxMS methodology for characterization of monoclonal antibody size variants. (Pubmed Central) - Jun 5, 2019 In this specific context, monomeric conformers were detected by IM-MS as HMWS or LMWS. Altogether, our results empha-size the power of comprehensive 2D LCxLC setups hyphenated to IMxMS in non-denaturing conditions with unprece-dented performance including: i) maintaining optimal SEC performance (under classical non volatile salt conditions), ii) performing online native MS identification, and iii) providing IM-MS conformational characterization of all sepa-rated size variants.
- |||||||||| Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma
Enrollment closed, Enrollment change: MAZERATI: Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept (clinicaltrials.gov) - Jun 3, 2019 P4, N=10, Active, not recruiting, Inflammatory activity at the time of adalimumab commencement may determine long-term treatment success. Recruiting --> Active, not recruiting | N=90 --> 10
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Biomarker, Review, Journal: Pre-Treatment Biomarkers of Anti-Tumour Necrosis Factor Therapy Response in Crohn's Disease-A Systematic Review and Gene Ontology Analysis. (Pubmed Central) - May 31, 2019 Our gene ontology analysis shows that these networks have roles in apoptotic signalling, response to oxidative stress and inflammation pathways. We conclude that a more systematic approach with genome-wide search of genomic and expression biomarkers in the same patients is needed in future studies.
- |||||||||| Journal: Management of Inflammatory Arthritis in pregnancy: a National Cross-Sectional Survey of Canadian rheumatologists. (Pubmed Central) - May 31, 2019
There was consensus with use of 4 biologics - adalimumab (81%), certolizumab (80%), etanercept (83%), and infliximab (76%) - in planned pregnancies but uncertainty on when they should be discontinued and their use in unplanned pregnancies. This national survey shows consensus among rheumatologists on the use of some csDMARDs and biologics/small molecules in IA patients planning pregnancy but varied knowledge on when to discontinue and what to do in unplanned pregnancies.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie
Journal: Bringing Humira (Its Price) Down a Peg. (Pubmed Central) - May 30, 2019 Very hard. Humira faces competition in Europe, but it will probably take years before its market share is challenged in the United States.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie
Clinical, Journal: Clinically important neutralizing anti-drug antibodies detected with an in-house competitive ELISA. (Pubmed Central) - May 29, 2019 Taken together, we developed innovative cELISAs enabling quantification of functional and neutralizing anti-drug antibodies, comparable to RGA. The association between cELISA results and loss of drug response in patients identified clinically important anti-drug antibodies, as measured by cELISA.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: A Randomized, Double-blind, Placebo-controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome. (Pubmed Central) - May 29, 2019 Women with moderate to severe refractory IC/BPS were more likely to experience significant improvement in symptoms with certolizumab pegol compared with placebo therapy. Further investigation of certolizumab pegol for the treatment of IC/BPS is warranted with a larger, longer, multicenter, randomized, placebo-controlled trial.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie
Clinical, Journal: A propensity score-matched comparison of infliximab and adalimumab in TNF-α inhibitors naïve and non-naïve patients with Crohn's disease: real-life data from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). (Pubmed Central) - May 29, 2019 Among non-naïve patients, a clinical benefit was achieved in 61.7% of patients treated with ADA and in 68.1% of patients treated with IFX (adjusted OR: 0.72, 95%CI 0.21-2.44, p=0.600) at 12 weeks; after one year, a clinical benefit was achieved in 48.9% of patients treated with ADA and in 40.4% patients treated with IFX (adjusted OR: 1.23, 95%CI 0.54-2.86, p=0.620). In this propensity score-matched comparison of ADA and IFX in CD, both drugs showed high rates of clinical benefit, without significant differences between them.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie
Clinical, Journal: Adalimumab-induced acute myeloid leukaemia in a patient with Crohn's disease. (Pubmed Central) - May 29, 2019 We present a patient with Crohn's disease under treatment with adalimumab who developed acute myeloid leukaemia (AML) with core-binding factor beta gene rearrangement. This case report emphasises the importance of long-term close follow-up of patients receiving adalimumab because of the increased risk of developing AML and other malignancies.
- |||||||||| Clinical, Journal: Safety of drugs used for the treatment of Crohn's disease. (Pubmed Central) - May 29, 2019
Data on vedolizumab and ustekinumab suggests these newer biologic agents are well-tolerated, however longer term data in CD is required to identify risks with extended use. Apart from methotrexate, there appears to be no adverse congenital outcomes with exposure of drugs during pregnancy.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie
Journal: National trends in prescription drug expenditures and projections for 2017. (Pubmed Central) - May 26, 2019 We project a 6.0-8.0% increase in total drug expenditures across all settings, an 11.0-13.0% increase in clinics, and a 3.0-5.0% increase in hospital drug spending in 2017. Health-system pharmacy leaders should carefully examine their own local drug utilization patterns to determine their own organization's anticipated spending in 2017.
- |||||||||| Clinical, Review, Journal: Recommendations for Initiating Systemic Therapy in Patients with Psoriasis. (Pubmed Central) - May 25, 2019
The authors discuss the barriers to use of systemic agents and highlight the central importance of each patient's perspective when assessing disease severity. Additionally, practical strategies for selecting and safely initiating systemic therapy to optimize the treatment of patients with psoriasis are identified.
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