Delving into the Latest Updates on Prednisolone/Prednisone with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target-

Mechanism-

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [4]

Active Indication-

Inactive Indication

AsthmaFollicular LymphomaMetastatic castration-resistant prostate cancer+ [1]

Originator Organization-

Active Organization-

Inactive Organization

SanofiHoffmann-La Roche, Inc.

GSK Plc

+ [1]

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

Structure

Molecular FormulaC21H26O5

InChIKeyXOFYZVNMUHMLCC-ZPOLXVRWSA-N

CAS Registry53-03-2

View All Structures (2)

A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (O-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"), have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory").
This study will be made up of Part 1a, Part 1b, and Part 2.The aim of Part 1a and Part 1b of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.
The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy, the current standard of care treatment approved for Non-Hodgkin's lymphoma (NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
What side effects may happen from taking the study drug when combined with chemotherapy
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
The impact from the study drug on your quality of life and ability to complete routine daily activities

Start Date13 Dec 2023

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT05489211 / RecruitingPhase 2

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

Start Date06 Sep 2022

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT05288166 / Active, not recruitingPhase 3

CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

Start Date14 Apr 2022

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Prednisolone/Prednisone

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100 Translational Medicine associated with Prednisolone/Prednisone

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100 Patents (Medical) associated with Prednisolone/Prednisone

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5

Literatures (Medical) associated with Prednisolone/Prednisone

01 Jan 2018·Rinsho Shinkeigaku

A case of neurolymphomatosis presented as cauda equine syndrome accompanied with M-proteinemia

Article

Author: Yamamoto, Mamoru ; Konishi, Hirofumi ; Nukui, Takamasa ; Dougu, Nobuhiro ; Nakatsuji, Yuji ; Taguchi, Yoshiharu

A 63-year-old man developed a syndrome of cauda equine, with the numbness which is a left lower extremity from the left buttocks, weakness of left leg, and a dysfunction of bladder and bowel. Enhanced MRI revealed the enhancement of lower cauda equine, and a nerve conduction test revealed decreased F-wave persistency in the tibial nerve and increased F-wave latency in the peroneal nerve on the both sides. M-proteinemia was admitted and myeloma was suspected. By a biopsy of a vertebral arch, we diagnosed with diffuse large B-cell lymphoma. We treated with dexamethasone and R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone (prednisolone)), then the symptom was improved. In case of caude equine syndrome with M-proteinemia, a possibility of the malignant lymphoma should also be considered.

01 Jan 2014·Blood Research

Second case of postpartum acquired hemophilia A in a Korean female

Article

Author: Shim, Ye Jee ; Lee, Kun Soo ; Jang, Kyoung Mi ; Hyun, Shin Young

TO THE EDITOR: Acquired hemophilia A (AHA) is a very rare condition with an incidence of about 1.5 per million of the general population per year [1]. It develops in middle age due to autoantibody production directly against the factor VIII (FVIII) and occurs in both sexes equally. The underlying conditions associated with AHA are other autoimmune diseases, malignancy, drugs and pregnancy. However, about half of AHA has no specific cause, thus they are called idiopathic. Postpartum AHA is a special category with distinct clinical manifestation contributing to 7-21% of patients with AHA [2, 3, 4]. In Korea, the first case of postpartum AHA in a 40 years old female has been reported by Lee et al. [5]. To the best of our knowledge, the present case report is the second one in Korea. A previously healthy 18 years old female had several minor bruises on hands and feet at 5 months after delivery. There was no specific complication immediately after delivery. She previously didn't take any drugs which could result in AHA and her family history was nonspecific. The hemorrhagic symptoms were aggravated during the process of time and she visited a private medical doctor at 8 months after delivery. At the medical clinic, she was only supplemented with iron to treat her iron deficiency anemia. Because of a persistent migrating painful swelling on her knees and ankle joints, multiple bruises and menorrhagia, she was transferred to our institute at 9 months after delivery. Her initial laboratory test results were as follows: PT 10.2 sec (normal range, 10-14 sec), INR 0.95 (normal range, 0.85-1.50), aPTT 84.3 sec (normal range, 20-40 sec), FVIII activity 1.4% (moderately decreased), and anti-FVIII antibody 28 Bedestha units (BU). Thus, she was confirmed as postpartum AHA. To manage her persisting hemorrhagic symptoms, activated prothrombin complex concentrate, FEIBA (Baxter, Westlake Village, CA, USA) was infused to her based on the dose for joint hemorrhage (50-100 units/kg every 12 hours until pain/disabilities are improved, maximum 200 units/kg/day) and her bleeding symptoms resolved. We closely followed up her at the outpatient clinic with on-demand FEIBA injection. After 2 months, the last follow up PT/aPTT were 11.2/95.1 sec, FVIII activity 1.5% and anti-FVIII antibody 40 BU. We consider giving corticosteroid to her additionally. According to European Acquired Haemophilia (EACH2) registry, 42 cases of postpartum AHA developed from 2003 to 2008 in 13 European countries [4]. In other words, the medical personnel in hematology or obstetrics can experience one postpartum AHA patient every year or biyearly in one country. Because time to diagnosis of postpartum AHA was 21-120 days after delivery, pregnant women should be observed closely approximately 1-3 months after delivery [4]. Usually, AHA is often misunderstood as another bleeding disorder like disseminated intravascular coagulation because a hemorrhage into the skin (purpura) or soft tissue is the most common presenting sign of AHA, while a hemarthrosis, the hole mark of a congenital hemophilia, occurs rarely [1, 2]. According to EACH2, hemarthrosis was also a rare hemorrhagic symptom of postpartum AHA contributing about 5%. Subcutaneous (45%) or mucosal bleeding (43%) was most common. On the other hand, in case of our report, the patient was mistaken as to have rheumatic disease because the migrating painful swelling of her joints due to hemarthrosis was the main symptom. The treatment of acute bleeding in case of postpartum AHA is not different from the general form. Two bypassing agents, FEIBA and the recombinant activated factor VII, NovoSeven (Novo Nordisk, Princeton, NJ, USA) are the main therapeutic agents to control acute hemorrhagic symptoms. The overall complete response rate of hemorrhages using FEIBA was 86% with the infusion of 75 units/kg every 8 to 12 hours [6]. And the efficacy rate using NovoSeven was 95% as first line therapy for AHA [7]. NovoSeven has some advantages that it's blood born viral transmission is shut out and the risk of thromboembolism is lower than that of FEIBA [8, 9]. The combination of bypassing agents for stopping the hemorrhage and immunosuppressive therapy is usually used together to eradicate the autoantibodies of FVIII in the general form of AHA. Prednisolone (prednisone), cyclophosphamide, azathioprine, 6-mercaptopurine, rituximab (anti-CD 20 monoclonal antibody), mycophenolate or cyclosporin have been used for treatment [1, 3, 10, 11, 12]. However, the immunosuppression may be individually reserved considering the advantages and disadvantages in case of postpartum AHA because of its more favorable prognosis compared to the general form. In retrospective reviews of postpartum AHAs, 86-100% of patients showed complete remission and survival rate was 97-100% [4, 12]. Further, there was no statistical difference of the time to complete remission between the postpartum AHA patients had immunosuppressive therapy and the rest of cohort [4]. On the other hand, the course of a general AHA is quite different. The relapse rate was about 20% after the cessation of immunosuppression and the survival rate was about 60% [1]. In some international survey, the recurrence rate of postpartum AHA was 0% [13, 14]. However, there is a controversy over the recurrence rate of anti-FVIII antibody in case of subsequent pregnancy. Large-scaled study about the recurrence rate is not available yet. Thus the patients who experienced postpartum AHA should be observed carefully after subsequent pregnancies. In the previous Korean case of postpartum AHA reported by Lee et al. [5], the patient was treated with a bypassing agent plus corticosteroid. In the present case, we are using on-demand FEIBA infusion for control of acute bleeding and postponed the immunosuppression considering a spontaneous remission. In our present case, the hemorrhagic symptoms of the patient were now solved using FEIBA. We expect that case presentations will help to increase the awareness on this rare condition among the medical personnel in the hematologic and obstetric field.

01 Oct 2001·Arthritis & Rheumatism

Resolved: Low‐dose prednisone is indicated as a standard treatment in patients with rheumatoid arthritis

Article

Author: Conn, D L

It is known and has been repeatedly demonstrated that low doses of prednisone or prednisolone (10 mg daily or 5 mg bid) will control most of the inflammatory features of early polyarticular rheumatoid arthritis (Table 2). Also, low doses of prednisolone are known to retard the bony damage of rheumatoid arthritis, and thus these are the original disease-modifying antirheumatic drugs. Glucocorticoids are potent antiinflammatory and immunosuppressive agents by virtue of their repression of the genomic expression by transcriptional interference, inhibiting such proinflammatory proteins as COX-2, IL-1, IL-2, IL-6, TNFalpha, and adhesion molecules. Nature has produced an ideal antiinflammatory and immunosuppressive agent, namely glucocorticoids, and it is up to us to use it in appropriate situations (e.g., active early inflammatory polyarticular rheumatoid arthritis) and in low doses, frequently daily divided doses. Low doses of glucocorticoids (prednisone or prednisolone) accomplish everything NSAIDs or COX-2 inhibitors accomplish but with more antiinflammatory effects, fewer side effects, and much less expense. It is certainly possible (but not precisely tested) that low doses of prednisone (prednisolone) enhance the effects of other DMARDs, including anti-TNF agents. The side effects of low-dose glucocorticoids are minimal. By using concomitant calcium and vitamin D and monitoring bone status with DEXA scans, the osteopenia potential of low doses of prednisone will be minimal. The use of low-dose prednisone without NSAIDs will put the patient at very little risk for stomach ulceration and bleeding.

100 Deals associated with Prednisolone/Prednisone

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Follicular Lymphoma	Phase 3	ZA	Hoffmann-La Roche, Inc.	15 Feb 2011
Metastatic castration-resistant prostate cancer	Phase 3	FR	Sanofi	22 Aug 2007
Follicular Lymphoma	Phase 2	TH	Hoffmann-La Roche, Inc.	15 Feb 2011
Follicular Lymphoma	Phase 2	MK	Hoffmann-La Roche, Inc.	15 Feb 2011
Follicular Lymphoma	Phase 2	BG	Hoffmann-La Roche, Inc.	15 Feb 2011
Follicular Lymphoma	Phase 2	RO	Hoffmann-La Roche, Inc.	15 Feb 2011
Follicular Lymphoma	Phase 2	FI	Hoffmann-La Roche, Inc.	15 Feb 2011
Follicular Lymphoma	Phase 2	PE	Hoffmann-La Roche, Inc.	15 Feb 2011
Follicular Lymphoma	Preclinical	MX	Hoffmann-La Roche, Inc.	15 Feb 2011
Metastatic castration-resistant prostate cancer	Preclinical	HU	Sanofi	22 Aug 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAN2018	Not Applicable	Muscular Dystrophy, Duchenne	-	Deflazacort	(pwjexbvtwp) = fyngmedvhr pqangvsjsc (mhdiogaacx, 13.5)	-	10 Apr 2018
				Prednisone/Prednisolone	-
EHA2017	Not Applicable	Relapse multiple myeloma	243	Cyclophosphamide and dexamethasone/prednisone	oatceyrmgm(qbcjfzguth) = hblqbahmjf orsokgkttx (ulbpievdpf, 4.56 - 27.96) View more	Positive	18 May 2017
				Lenalidomide and dexamethasone	oatceyrmgm(qbcjfzguth) = wrufzaagzh orsokgkttx (ulbpievdpf, 4.80 - 29.16) View more
Pubmed \| Prostaglandins Leukot Essent Fatty Acids	Not Applicable	-	-	Prednisolone 7.5 mg/day	jthmkdmiub(vucepxrkpm) = hkvlkpktfn txlzgvtrqq (gmbjvgmgyg, 14.8; 87.6) View more	-	01 May 2018
				Prednisolone 30 mg/day	jthmkdmiub(vucepxrkpm) = bnhmxitybi txlzgvtrqq (gmbjvgmgyg, 14.8; 87.6) View more
NCT03407144 (KEYNOTE-667, EHA2022) Manual	Phase 2	Classical Hodgkin's Lymphoma First line	30	dacarbazine+vincristine+cyclophosphamide+prednisone/prednisolone+pembrolizumab	(lhylmzzvdq) = bcuyxwjeit yizgawnbfp (vspiymsisx ) View more	Positive	12 May 2022
LB-S&T-24 (AUA2016)	Not Applicable	Castration-Resistant Prostatic Cancer	18,602	Docetaxel plus prednisone/prednisolone	(vhvdhwuavr): HR = 0.7 (95% CI, 0.59 - 0.82)	-	01 Apr 2016
				Cabazitaxel plus docetaxel plus prednisone/prednisolone
NCT02043678 (ERA 223, ESMO2018)	Phase 3	Metastatic castration-resistant prostate cancer	806	Abiraterone acetate and prednisone/prednisolone + Radium-223	(jmdywblsyr) = gyxdasrtur xzmicgknku (zlhhobzocf ) View more	Negative	19 Oct 2018
				Abiraterone acetate and prednisone/prednisolone + Placebo	(jmdywblsyr) = jakixhataf xzmicgknku (zlhhobzocf ) View more