hydrocortisone acetate rectal aerosol / Generic mfg. - LARVOL DELTA

Cristcot Announces Positive Phase 3 Results for Novel Hydrocortisone Acetate Suppository Administered with the Sephure Suppository Applicator for the Treatment of Ulcerative Colitis of the Rectum (PRNewswire) - P3 | N=200 | NCT04469686 | Sponsor: Cristcot LLC | "The trial achieved its primary endpoint of clinical remission, defined as a Modified Mayo Score of 0-2, which includes rectal bleeding sub-score of 0, reduction of stool frequency from baseline with sub-scores of 0 or 1 and mucosal healing as determined by an endoscopic sub-score of 0 or 1. In the once-daily (QD) treatment arm, 23.0% of patients achieved clinical remission by Day 29. In the twice-daily (BID) treatment arm, 17.5% of patients achieved clinical remission by Day 29...Rapid clinical response for both, rectal bleeding = 0 and reduction of stool frequency = 0 or 1, was observed in both active treatment arms by Day 15...'During the first quarter of 2025 we will be finalizing our NDA submission as we continue to build our manufacturing and commercial capabilities to bring this potentially transformative therapy to patients in the U.S.'"

FDA filing • P3 data • Ulcerative Colitis

Expanded table: Some drugs for inflammatory bowel disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Drugs for inflammatory bowel disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Delaying Time to Metastasis in Patients With High-Risk, M0 CRPC With Radiolabeled J591 Plus Ketoconazole and Hydrocortisone - Scott Tagawa (Urotoday) - "Scott Tagawa...to discuss a randomized phase II study on a salvage anti-PSMA radioimmunotherapy targeting non-metastatic CRPC population."

Video

Results of the Full Pediatric, Minimal Residual Disease (MRD)-Oriented Trial LAL-RI/2008 for Adolescents and Young Adults (AYA) with Standard Risk (SR), Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia (ALL) (ASH 2017) - P4; "...Induction therapy included vincristine (VCR), prednisone (PDN), daunorubicin (DNR) and native E. coli asparaginase (ASP) for 4 weeks. Pts who achieved complete remission (CR) and MRD<0.1% proceeded to consolidation-1 (high-dose methotrexate [MTX], intermediate-dose ARA-C, etoposide and mercaptopurine [MP]), consolidation-2/reinduction (VCR, dexamethasone, DNR, cyclophosphamide and ASP), maintenance-1 (MP and MTX with monthly reinductions with VCR, PDN and ASP until the end of the 1st year) and maintenance-2 (MP and MTX without reinductions until the end of the 2nd year). CNS prophylaxis consisted of triple intrathecal therapy (MTX, ARA-C and hydrocortisone, 16 doses throughout the treatment)...Twenty-five percent of AYA pts with SR ALL at baseline are in fact HR based on slow early cytological response to therapy and/or poor MRD clearance. High-risk pts showed lower OS despite being moved to a HR protocol.nSupported in part by grants RD12/0036/0029 (RTICC, FEDER),...

Clinical • Residual disease • Acute Lymphocytic Leukemia • Biosimilar

The Science of COVID-19: COVID-19 and Treatment of Adults - "Dr Moti Ramgopal...who led the clinical trial on COVID-19 treatment given to US President Donald Trump. Since March this year, I have treated hundreds of cases of patients infected with COVID-19, but three cases in particular have aroused my curiosity about the genetic relationship of COVID-19. Do genes play a role in how severe symptoms will be?"

Media quote

Systemic Steroids Reduce Mortality in COVID-19 (RheumNow) - "This meta-analysis included 7 randomized trials, 1703 patients who were randomized to receive systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo (1025 patients)....This prospective meta-analysis shows that systemic corticosteroids in critically ill patients with COVID-19 was associated with a lower 28-day all-cause mortality."

Online posting

PD-L1 Inhibitor-Associated Diarrhea in a Patient With Stage IV NSLC (WCOG@ACG 2017) - "The stool was lately more watery,numerous and associated with cramps.Physical exam revealed somewhat distended abdomen that was tender to palpation periumbilically.Multiplex PCR tests for identifying GI pathogens and C.Diff PCR were negative and other infectious causes were ruled out.CT Abdomen revealed long segment enteritis, most prominently in the duodenum, without any evidence of colitis.An upper endoscopy and colonoscopy revealed mild inflammation in the duodenum and spasm in the colon with some semi-solid stool throughout.Pathology showed a regenerative pattern with features of chronicity, active inflammation and scattered apoptotic cells-strongly suggestive of a drug-induced lesion, likely nivolumab-related autoimmune enteritis.The patient’s earlier dose of 40mg prednisone PO was changed to 100mg IV q8h hydrocortisone with resolution of the diarrhea. Nivolumab is an anti PDL-1 monoclonal antibody that blocks the interaction of PD-1 and PDL-1 to prevent T-cell..."

Clinical • Immunology

Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2; N=55; Not yet recruiting; Sponsor: Northwestern University

New P1/2 trial • Biosimilar • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement (clinicaltrials.gov) - P1; N=116; Recruiting; Sponsor: National Cancer Institute (NCI); Phase classification: P=N/A ➔ P1

Phase classification • Acute Lymphocytic Leukemia • Biosimilar

Isolated ACTH deficiency probably induced by autoimmune-related mechanism evoked with nivolumab. (PubMed) - "Finally, hydrocortisone replacement enabled the patients to continue nivolumab treatment. Therefore, it is important to consider isolated ACTH syndrome as a possible and potentially severe immune-related adverse event of nivolumab, even when head magnetic resonance imaging of affected cases does not show enlargement. We should not misdiagnose hidden immune-related adverse events behind general complaints of malignancies such as general malaise and appetite loss, to allow successful treatment using this beneficial immune checkpoint inhibitor."

Journal • Biosimilar • Immunology • Melanoma • Renal Disease

Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (clinicaltrials.gov) - P2; N=28; Recruiting; Sponsor: University of Washington; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1b; N=36; Suspended; Sponsor: Amgen; Recruiting ➔ Suspended; Trial primary completion date: Dec 2017 ➔ Jul 2018

Trial primary completion date • Trial suspension • Acute Lymphocytic Leukemia • Biosimilar

Ipilimumab/ Nivolumab Induced Adrenal Insufficiency in a Patient with Metastatic Malignant Melanoma (ENDO 2017) - "...Labs significant for hyponatremia ( 127mmoL/L, n 135-145 mmoL/L) , normal potassium (3.9 mmol/L, n 3.5-5.1 mmol/L).Baseline morning cortisol (1.1 ug/dL, n am 6.7-22.6ug/dL),ACTH ( 4.2pg/ml, n 7.2-63.3 pg/ml)obtained and meanwhile cosyntropin stimulation test done and cortisol after 30 min and 60 min ( 8.6 ug/dL,14.6 ug/dL ,n>18 ug/dL). Meanwhile stress dose glucocorticoids given (Hydrocortisone 100 mg iv one dose followed by 50 mg iv every 6 hourly).Pituitary panel was done and significant for low testosterone (1.1 ng/mL, n 1.8-7.8 ng/mL) with low normal LH (4.2 mIU/mL, n 1.2-8.6 mIU/mL) and FSH (3.5 mIU/mL, n 1.3-19.3 mIU/mL) suggestive of gonadal axis suppression due to acute stress.TSH was suppressed (TSH-0.01 uIU/mL, n 0.34-5.6 uIU/mL) with normal free T4 (0.92 ng/dL, n 0.61-1.12 ng/dL) and Total T3 (106 ng/dL, n 71-180 ng/dL) suggestive of subclinical thyrotoxicosis related to thyroiditis.MRI pituitary was done which showed 2 mm hypoenhancement in the pituitary..."

Clinical • Biosimilar • Cardiovascular • Heart Failure • Immunology • Melanoma • Oncology • Ophthalmology • Pain • Renal Disease

Diabetes Insipidus and Hypopituitarism in a Patient with Diffuse Large B Cell Lymphoma with Minimal Findings on MRI Brain (ENDO 2017) - "...She received two cycles of R- CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin and prednisolone) chemotherapy and intrathecal methotrexate...Further biochemical tests showed; baseline plasma ACTH 25 pg/mL (n 6-58 pg/mL), 250 μg cosyntropin stimulation test showed cortisol results at 0 minute of 13.2 mcg/dL, 30 minutes of 12.2 mcg/dL and 60 minutes of 30 mcg/dL...She was started on hydrocortisone and thyroxine replacement and she subjectively improved...Diffuse large B-cell lymphoma is a rare cause of central diabetes insipidus and hypopituitarism. MRI brain can be normal and more detailed imaging studies might be required to confirm the diagnosis."

Clinical • Biosimilar • Diabetic Nephropathy • Diffuse Large B Cell Lymphoma • Gene Therapies • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia (clinicaltrials.gov) - P2; N=39; Recruiting; Sponsor: St. Jude Children's Research Hospital

New P2 trial • Acute Myelogenous Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Incidence of Central Nervous System Hemophagocytic Lymphohistiocytosis Relapse after Reduced Intensity Conditioning Stem Cell Transplant in Children (BMT 2017) - "...We performed a retrospective chart review of 94 consecutive patients with HLH who received RIC HSCT with alemtuzumab, fludarabine, and melphalan (Table 1)...All patients with CNS disease following HSCT responded with CNS directed therapy with intrathecal hydrocortisone and methotrexate and/or systemic dexamethasone...Response to therapy appears excellent. Surveillance CSF evaluation following allogeneic RIC HSCT should be performed in patients with risk factors, and CNS directed treatment initiated if appropriate."

Retrospective data • Biosimilar • Epilepsy

Treatment of Acute Lymphoblastic Leukemia in Children (clinicaltrials.gov) - P3; N=800; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial primary completion date: Jun 2015 ➔ Aug 2014

Trial primary completion date • Acute Lymphocytic Leukemia • Biosimilar

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer (clinicaltrials.gov) - P2; N=140; Recruiting; Sponsor: Weill Medical College of Cornell University; Trial primary completion date: Dec 2015 ➔ Dec 2017

Trial primary completion date • Biosimilar • Oncology • Prostate Cancer

Topical hydrocortisone 17-butyrate 21-propionate in the treatment of inflammatory skin diseases: pharmacological data, clinical efficacy, safety and calculation of the therapeutic index. (PubMed) - Pharmazie - "A therapeutic index of 2.0 can be attributed to this glucocorticoid. In this respect, there is no difference between topical HBP and other topical glucocorticoids with increased benefit/risk ratio, e.g. prednicarbate (PC), methylprednisolone aceponate (MPA) and mometasone furoate (MM)."

Journal • Review • Biosimilar • Dermatitis • Eczema • Immunology • Psoriasis

Androgen deprivation by adrenal suppression using low-dose hydrocortisone for the treatment of breast carcinoma with apocrine features: a case report illustrating this new paradigm. (PubMed) - Breast Cancer Res Treat - "Future clinical trials should not only focus on AR inhibitors like enzalutamide, but also on ablative modalities like low-dose hydrocortisone aiming at medical adrenalectomy. This method of androgen deprivation is largely available, cheap, and nearly devoid of toxicity."

Journal • Biosimilar • Breast Cancer • Oncology • Triple Negative Breast Cancer

Thyrotoxic and pheochromocytoma multisystem crisis: a case report. (PubMed, J Med Case Rep) - "Since he required more intensive cardiovascular management for thyrotoxic crisis, beta blockade was increased under intensive care unit monitoring even though initial alpha blockade is recommended in pheochromocytoma. When these crises occur simultaneously, cardiovascular management can be very challenging."

Journal • Biosimilar • Neuroendocrine Tumor • Oncology • Solid Tumor

Vanishing insulin requirements in patient with type 1 diabetes (Sfe BES 2016) - "She was commenced on levothyroxine and hydrocortisone. Short synacthen test showed baseline cortisol of 71 nmol/l, 30 min 233 nmol/l. Her basal insulin requirements fell from 36 units to 24 units per day and she required little if any insulin as bolus (0.5 unit for every 10 gm). We would like to take this opportunity to discuss and remind ourselves Sheehans syndrome a possible reason for diminishing insulin requirements in postpartum patients with Type 1 Diabetes. Is it vanishingly rare."

Clinical • Biosimilar • Diabetes

Major publications in the critical care pharmacotherapy literature: January-December 2016. (PubMed, J Crit Care) - "The review provides a synopsis of select pharmacotherapy publications in 2016 applicable to clinical practice."

Journal • Review • Biosimilar • Cardiovascular • Hematological Malignancies • Oncology • Venous Thromboembolism

Severe Hypotension, Hypoxia, and Subcutaneous Erythema Induced by Indigo Carmine Administration during Open Prostatectomy. (PubMed) - Case Rep Urol - "After treatment with 100% oxygen, epinephrine (total, 1.5 mg), hydrocortisone (100 mg), diphenhydramine (50 mg), albuterol nebulizer (0.083%), and continuous infusion of epinephrine (0.15 μg/kg/min), the vital signs became stable, and he recovered completely. In summary, indigo carmine rarely may cause life-threatening anaphylactic or anaphylactoid reaction that may necessitate rapid treatment to stabilize cardiovascular, hemodynamic, and pulmonary function."

Journal • Biosimilar • Immunology • Oncology • Prostate Cancer