- |||||||||| Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen
EFFECTS OF METABOLIC PHARMACOTHERAPY IN REAL WORLD PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD) () - Oct 23, 2022 - Abstract #AASLD2022AASLD_1403;
Classes of pharmacotherapy included antihyperglycemic agents (GLP-1 receptor agonists (GLP-1 RAs), SGLT2 inhibitors, DPP-4 antagonists, metformin) and appetite suppressants (phentermine, topiramate, bupropion). Prospective real-world data from ICHANGE suggests antihyperglycemic agents, specifically GLP-1 RAs, are effective in weight loss and improvements in fibrosis and steatosis scores in patients with NAFLD.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Entyvio (vedolizumab) / Takeda
Clinical guideline, Review, Journal: Korean clinical practice guidelines on biologics for moderate to severe Crohn's disease. (Pubmed Central) - Oct 18, 2022
The third Korean guidelines for CD management provide updated information regarding treatment of moderate-to-severe CD patients with biologic agents. (Intest Res, Published online).
- |||||||||| Ongentys (opicapone) / Ono Pharma, Neurocrine, BIAL
Parkinson’s Disease Patient Characteristics in a US Real-World Study of Opicapone () - Oct 17, 2022 - Abstract #ANA2022ANA_605;
While the study was conducted during the ongoing pandemic and investigators could initiate treatment via telemedicine, most investigators elected to initiate patients on opicapone with an in-person visit. Findings from OPTI-ON will further characterize the PD population treated with opicapone and real-world clinician- and patient-reported outcomes data in the US will complement results from previous controlled clinical trials.
- |||||||||| Comtan (entacapone) / Novartis, Orion Corp, Ongentys (opicapone) / Ono Pharma, Neurocrine, BIAL
Review, Journal: Relevance of COMT inhibitors in the treatment of motor fluctuations (Pubmed Central) - Oct 12, 2022
Many patients with motor fluctuations are currently not treated with COMT inhibitors and are, therefore, unlikely to receive individually optimized drug treatment. This manuscript summarizes the results of a working group including several Parkinson's disease experts, in which the value of COMT inhibitors was critically discussed.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Clinical, P4 data, Journal: Safety, efficacy, and drug survival of the infliximab biosimilar CT-P13 in post-marketing surveillance of Japanese patients with psoriasis. (Pubmed Central) - Oct 12, 2022
In conclusion, CT-P13 showed excellent effectiveness as a first-line therapy, no clinical difficulties in switching from IFX, and usefulness in patients who failed other biologics. CT-P13 could be a cost-effective alternative to IFX for the treatment of psoriasis.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Evaluation of persistence, retention "rate" and prescription pattern of original infliximab and infliximab CT-P13 in biologic-naïve patients with ulcerative colitis. (Pubmed Central) - Oct 9, 2022
This study indicated that the Remsima kit was reproducible and highly correlated with the RIDA kit. There are no significant differences in persistence, retention, and number of intensifications or deintensifications between iologicnaïve patients treated with Remicade® and those treated with Remsima®, the latter being an effective, safe and economical alternative for the treatment of ulcerative colitis.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Switching high-dose infliximab in patients with active inflammatory bowel disease: The SHIPI study () - Oct 4, 2022 - Abstract #AGW2022AGW_444;
The switch from originator to biosimilar agents in this study was not associated with any significant change in infliximab level. We can be reassured that, even when used at very high doses, switching between infliximab brands is unlikely to significantly affect drug pharmacokinetics.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remsima SC (infliximab biosimilar SC) / Celltrion
Journal: Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study. (Pubmed Central) - Sep 24, 2022
The CT-P13 SC brings a new anti-TNF era. Achieving much higher drug levels that are constant over time opens new paths to explore the management of patients with IBD: less immunogenicity, better perianal disease control and higher achievement of mucosal healing.
- |||||||||| Xadago (safinamide) / Meiji Seika, Eisai, Valeo Pharma, Zambon, Supernus Pharma
SAFINAMIDE: REAL LIFE STUDY. EFFICACY IN SWITCH FROM RASAGILINA AND LOW-DOSE TREATMENT. (Poster Station: 12) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_1012;
We present a prospective observational-real life study about the use of safinamide in PD patients in our Movement Disorders Unit We evaluate safinamide´s effects in 93 patients (52.7% women, mean age 67.8 years (SD 10.9), disease duration 8.3 (SD 5.5), in combinated therapy with levodopa and dopamine agonists 68.8%, entacapone 29.03%, opicapone 16.12% and advanced therapies 2.1%. Safinamide is safe in terms of adverse effects, especially improving motor fluctuations, motor-symptoms and subjective perception of PD severity, even in patients who switch rasagiline to safinamide or in patients treatment with low safinamide doses (50mg/24h)
- |||||||||| Comtan (entacapone) / Novartis, Orion Corp, Xadago (safinamide) / Meiji Seika, Eisai, Valeo Pharma, Zambon, Supernus Pharma, Ongentys (opicapone) / Ono Pharma, Neurocrine, BIAL
Systematic Review and Network Meta-Analysis of COMT and MAO-B Inhibitors in Parkinson’s Patients with Motor Fluctuations (Poster Station: 4) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_974;
Tolcapone and opicapone appeared to be the best performing drugs. Supported by Bial
- |||||||||| Comtan (entacapone) / Novartis, Orion Corp
Phantom Pregnancy – A Novel Impulse Control Behaviour in Parkinson’s Disease: A Case Report (Poster Station: 1) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_956;
The patient had self-discontinued amantadine and rasagiline believing they could cause congenital abnormalities in the baby... This case highlights the importance of robust recognition of ICDs and the possibility that they can present in a unique form such as that of phantom pregnancy in PD.
- |||||||||| Review, Journal: Which is the optimal antiobesity agent for patients with nonalcoholic fatty liver disease? (Pubmed Central) - Sep 21, 2022
The glucagon-like peptide-1 receptor agonists, liraglutide and semaglutide, appear to represent a first-line option in obese patients with NAFLD and type 2 diabetes mellitus (T2DM) since they induce considerable weight loss and have been extensively studied in patients with T2DM. However, more studies are needed to evaluated their effects on liver-related and cardiovascular outcomes in patients with NAFLD, particularly in those without T2DM.
- |||||||||| topiramate / Generic mfg.
Association of Topiramate Use with Current Stone Activity -- A Population Based Analysis (NH/VT Room) - Sep 15, 2022 - Abstract #NEAUA2022NEAUA_8;
Additionally, we provide the initial quantification of the strength of this association, with an estimated 8-fold increase in odds of stone formation. These findings can provide physicians with important data and improve risk counseling for patients considering topiramate use.
- |||||||||| Victoza (liraglutide) / Novo Nordisk, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen, Xenical (orlistat) / Roche, GSK
Journal: Anti-obesity therapy for cardiovascular disease prevention: potential expected roles of glucagon-like peptide-1 receptor agonists. (Pubmed Central) - Sep 14, 2022
To overcome this unmet clinical need, newer anti-obesity drugs must exhibit not only sufficient and long-lasting weight loss but also obvious cardiovascular benefits. Given recent clinical findings and evidences, in this context glucagon-like peptide-1 receptor agonist is currently available as a candidate that is clinically positioned as a first-line anti-obesity agent for the effective prevention of ORCVDs in people with obesity.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden. (Pubmed Central) - Sep 10, 2022
Given recent clinical findings and evidences, in this context glucagon-like peptide-1 receptor agonist is currently available as a candidate that is clinically positioned as a first-line anti-obesity agent for the effective prevention of ORCVDs in people with obesity. This large observational study supports the equivalence of biologic DMARD biosimilar products and originators when used in routine rheumatology care.
- |||||||||| Victoza (liraglutide) / Novo Nordisk, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen, Xenical (orlistat) / Roche, GSK
Effectiveness and Safety of Weight Loss Medical Therapy in Ulcerative Colitis (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_3574;
No patients were identified using orlistat. At baseline, twenty patients (83%) were in clinical remission and seven (29%) were treated with a biologic therapy.
- |||||||||| vancomycin / Generic mfg.
Successful Treatment of Complicated Ulcerative Colitis With Oral Vancomycin in a Patient With Primary Sclerosing Cholangitis (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_2871;
Numerous case reports have described the benefit of oral vancomycin in patients with UC-PSC in both adult and pediatric patients. This case adds to that body of evidence, and also highlights the need for safe, effective agents for inflammatory bowel disease that can be used in patients without concern of activating or exacerbating infections such as tuberculosis, hepatitis B, or in the case of our patient, disseminated coccidiomycosis.
- |||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Infliximab Clearance and Exposure Are Comparable Between Originator Remicade and Biosimilars in Clinical Gastroenterology Practice (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_2051;
Overall, the PK were comparable between Originator and Biosimilars, although a small trend toward higher Clearance was observed in patients who received Biosimilars as compared to those who received Originator IFX (0.277±0.004 vs 0.262±0.001 L/day, respectively) (p< 0.001). Higher ATI’s were observed with Biosimilars vs Originator (19% [136/714] vs 15% [1320/8876], respectively) (p< 0.001) as well as lower exposure (7.6±0.3 vs 8.5±0.1 µg/mL, respectively) (p< 0.001).
- |||||||||| Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen
Biomarker, Enrollment open, Trial initiation date: Risk of Metabolic Adaptation After Weight Loss (clinicaltrials.gov) - Aug 29, 2022
P=N/A, N=60, Recruiting,
Higher ATI’s were observed with Biosimilars vs Originator (19% [136/714] vs 15% [1320/8876], respectively) (p< 0.001) as well as lower exposure (7.6±0.3 vs 8.5±0.1 µg/mL, respectively) (p< 0.001). Not yet recruiting --> Recruiting | Initiation date: May 2022 --> Sep 2022
- |||||||||| Visken (pindolol) / Novartis, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate (clinicaltrials.gov) - Aug 22, 2022
P2, N=134, Recruiting,
There were no statistical differences in serum infliximab trough levels and ADA levels between CT-P13 and originator infliximab. Trial completion date: Feb 2023 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2024
- |||||||||| Ongentys (opicapone) / Ono Pharma, Neurocrine, BIAL
Preclinical, Journal: In vitro effects of opicapone on activity of human UDP-glucuronosyltransferases isoforms. (Pubmed Central) - Aug 18, 2022
Furthermore, the DDI risk was quantitatively predicted by using the in vitro-in vivo extrapolation (IVIVE). The prediction suggested that co-administration of opicapone at 25mg/day or 50mg/day with drugs primarily cleared by hepatic UGT1A9 or intestinal UGT1A1, 1A7, 1A8, 1A9, or 1A10 might result in potential DDI via inhibition of intestinal or hepatic UGTs.
- |||||||||| Ongentys (opicapone) / Ono Pharma, Neurocrine, BIAL
Review, Journal: Evaluating Opicapone as Add-on Treatment to Levodopa/DDCI in Patients with Parkinson's Disease. (Pubmed Central) - Aug 16, 2022
Whilst patients in the earlier Hoehn and Yahr stages benefit more than patients in later stages, the incidence of dyskinesia in patients with recent onset MF is around half that of patients with more established fluctuations. With the added advantage of a once-daily administration, this particular COMT inhibitor provides a simple, yet effective therapy for patients with Parkinson's disease and MF.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NRx Pharma, Alvogen
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: SBD-ASIB: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (clinicaltrials.gov) - Aug 12, 2022
P3, N=72, Active, not recruiting,
With the added advantage of a once-daily administration, this particular COMT inhibitor provides a simple, yet effective therapy for patients with Parkinson's disease and MF. Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P3 | Trial completion date: Apr 2022 --> Sep 2023 | Trial primary completion date: Mar 2022 --> Jun 2023
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