- |||||||||| Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma, Cimzia (certolizumab pegol) / Astellas, UCB
CIRCULATING ADIPOKINES AND RESPONSE TO TREATMENT IN EARLY RHEUMATOID ARTHRITIS () - May 29, 2024 - Abstract #EULAR2024EULAR_3440; Baseline adiponectin, leptin, and resistin levels are not associated with the likelihood of achieving CDAI remission over 48 weeks in this large trial of first-line treatments in early RA. Our results underscore the importance of adjusting for confounders when studying the effects of adipokines on RA outcomes, as circulating adipokine levels are highly dependent on other factors, such as BMI and sex.
- |||||||||| FOLLOW-UP DATA ON DRUG-INDUCED LUPUS CASES DURING TNF-ALPHA INHIBITOR TREATMENT () - May 29, 2024 - Abstract #EULAR2024EULAR_3249;
In patients who develop positive ds-DNA during the use of TNF inhibitors and exhibit mild symptoms, close monitoring while continuing the TNF inhibitor appears to be safe. Larger-scale studies are needed to establish a diagnosis, treatment, and follow-up algorithm in this field.
- |||||||||| PRIM-DJ2727 / UT Health Science Center, Vowst (fecal microbiota spores, live-brpk) / Seres Therap, Nestle, Rebyota (fecal microbiota, live-jslm) / Ferring
Review, Journal: Microbiota restoration therapies for recurrent Clostridioides difficile infection reach an important new milestone. (Pubmed Central) - May 27, 2024 It is as effective in promoting a similar response in women without significant comparable adverse effects. PubMed was reviewed on 1 October 2023, for all papers published concerning the current Food and Drug Administration allowance of the use of fecal microbiota transplantation (FMT) and the studies that led to the licensure of RBX2660 (REBYOTA
- |||||||||| Review, Journal: Biologics for Psoriasis. (Pubmed Central) - May 26, 2024
IL-23 inhibitors had lowest rates of short-term and long-term adverse events and most favorable long-term risk-benefit profile compared to IL-17, IL-12/23, and TNF-? inhibitors.
- |||||||||| VE303 / Vedanta Biosci, Vowst (fecal microbiota spores, live-brpk) / Seres Therap, Nestle, Rebyota (fecal microbiota, live-jslm) / Ferring
Review, Journal: A Comparison of Currently Available and Investigational Fecal Microbiota Transplant Products for Recurrent Clostridioides difficile Infection. (Pubmed Central) - May 24, 2024 This article will be an in-depth review of five microbiome therapeutic products that are either under investigation or currently commercially available: Rebyota (fecal microbiota, live-jslm, formerly RBX2660), Vowst (fecal microbiota spores, live-brpk, formerly SER109), VE303, CP101, and RBX7455. Included in this review is a comparison of the products' composition and dosage forms, available safety and efficacy data, and investigational status.
- |||||||||| olamkicept (FE999301) / Ferring
Clinical, P1 data, PK/PD data, Clinical Trial,Phase I, Journal: Safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of olamkicept: Results from randomized, placebo-controlled, first-in-human phase I trials. (Pubmed Central) - May 21, 2024 Complete target engagement (inhibition of phosphorylation of signal transducer and activator of transcription-3) was achieved in blood around or above olamkicept serum concentrations of 1-5 ?g/mL. Overall, these results suggest that olamkicept is safe and well-tolerated in healthy subjects and patients with CD after single intravenous/SC and multiple intravenous administrations.
- |||||||||| Review, Journal: Clostridioides Difficile: A Concise Review of Best Practices and Updates. (Pubmed Central) - May 10, 2024
In 2021, the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America (IDSA/SHEA) shifted its preference for initial treatment to fidaxomicin over vancomycin and metronidazole due to its lower recurrence rate...There are new developments on the frontiers of fecal microbiota therapies, with RBX2660 and SER-109 approved recently by the FDA for prevention, with other microbiome-based therapies in various development and clinical trials. This review offers providers an updated and practical guide for CDI management.
- |||||||||| Oncofid-P (paclitaxel-hyaluronic acid conjugate) / Fidia Farmaceutici
A PHASE III, SINGLE-ARM STUDY TO EVALUATE THE EFFICACYAND SAFETY OF PACLITAXEL-HYALURONIC ACID CONJUGATE ADMINISTERED INTRAVESICALLY TO PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER WITH OR WITHOUT TA-T1 PAPILLARY DISEASE (ORION-BC STUDY) () - May 8, 2024 - Abstract #AUA2024AUA_4230; P3 InJanuary 2020, the Food and Drug Administration (FDA) approvedpembrolizumab (Keytruda, Merck&Co) for the systemic treatment ofpatients with BCGeunresponsive, high-risk NMIBC with CIS, with orwithout papillary tumors, who are ineligible for or choose not to undergoRC...In 2022 intravesical Adstiladrin (Ferring), which acts bystimulating immune responses, was approved by the FDA based onefficacy on 50 subjects out of 107 enrolled [51% (95% CI: 41%, 61%)]who experienced a CR at the first disease assessment three monthsafter initial treatment...gemcitabine and docetaxel, Milbar 2017)...Up to 146 patients will be enrolled: up to now 9 patientswere enrolled and treated. The first DSMB meeting is scheduled end of January 2024.
- |||||||||| Firmagon (degarelix) / Astellas, Ferring, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
New P3 trial: ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer (clinicaltrials.gov) - May 3, 2024 P3, N=392, Recruiting,
- |||||||||| Biologic and Small-Molecule Treatments in Scalp and Nail Psoriasis () - May 2, 2024 - Abstract #INDERCOS2024INDERCOS_40;
6 Roflumilast foam 0.3% was evaluated in a phase II trial in patients with scalp and body psoriasis...A total of 68 studies on 15 nail psoriasis targeted therapeutic agents which are TNF-alpha inhibitors (adalimumab, infliximab, etanercept, certolizumab, golimumab), IL-17 inhibitors (ixekizumab, brodalumab, secukinumab), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab), PDE-4 inhibitors (apremilast), and JAK inhibitors (tofacitinib)...9 The therapy choices in NP have increased with the approval of new biologics and small molecules such as brodalumab, risankizumab, tildrakizumab, bimekizumab, and deucravacitinib...However, most RCTs assessing SP and NP outcomes are subgroup or post-hoc analyses of patients with scalp and nail involvement among larger PsO/PsA populations. RCTs particularly focusing on SP and NP are needed for better evaluation of efficacy and safety results of biologic and small molecule inhibitors.
- |||||||||| Firmagon (degarelix) / Astellas, Ferring
Journal: Effects of Follicle Stimulating Hormone on Energy Balance and Tissue Metabolic Health After Loss of Ovarian Function. (Pubmed Central) - Apr 30, 2024 Female Wistar rats were ovariectomized and given the gonadotropin releasing hormone (GnRH) antagonist degarelix to suppress FSH production...Additionally, rats administered FSH had reduced liver triglyceride concentration (p<0.001), which correlated with FSH-induced changes at the transcriptomic level. While not appearing to modulate energy balance after loss of ovarian function in rats, FSH may still impart tissue-specific effects in the liver and white adipose tissue that might affect the metabolic health of those organs.
- |||||||||| Firmagon (degarelix) / Astellas, Ferring
Enrollment open, Trial initiation date, Trial primary completion date: NeoADT-TULSA: Neoadjuvant ADT with TULSA in the Treatment of Intermediate Risk Prostate Cancer (clinicaltrials.gov) - Apr 24, 2024 P1, N=15, Recruiting, While not appearing to modulate energy balance after loss of ovarian function in rats, FSH may still impart tissue-specific effects in the liver and white adipose tissue that might affect the metabolic health of those organs. Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Oct 2023 | Trial primary completion date: Jul 2025 --> Dec 2025
- |||||||||| Firmagon (degarelix) / Astellas, Ferring
Clinical Trial,Phase IV, Journal: Relationship between circulating FSH levels and body composition and bone health in patients with prostate cancer who undergo androgen deprivation therapy: The BLADE study. (Pubmed Central) - Apr 24, 2024 P4 All patients underwent administration of the luteinizing hormone-releasing hormone antagonist degarelix...The funder had no role in design and conduct of the study, collection, management, analysis, and interpretation of the data and in preparation, review, or approval of the manuscript. clinicalTrials.gov NCT03202381, EudraCT Number 2016-004210-10.
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