Latest news with #EGPA
Medscape
a day ago
- Health
- Medscape
Rituximab No Better Than Standard Therapy for EGPA Remission
TOPLINE: Rituximab did not show superiority over conventional therapy in inducing remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA). Both treatment groups had similar remission rates at 180 and 360 days, with no significant differences in relapse rates or adverse events. METHODOLOGY: A phase 3, multicenter, randomized, controlled superiority trial was conducted in France to compare rituximab with conventional therapy for EGPA remission induction. A total of 105 adult patients with active EGPA (mean age, 58.4 years; 52.4% women), defined by a Birmingham Vasculitis Activity Score (BVAS, version 3) ≥ 3, were enrolled between December 2016 and October 2019 and randomly assigned to receive either rituximab (n = 52) or conventional therapy on the basis of the five-factor score (n = 53). Patients in the rituximab group received 1 g of rituximab on days 1 and 15, along with glucocorticoids on a tapering schedule; those with a five-factor score ≥ 1 received placebo-cyclophosphamide and placebo-uromitexan. The conventional therapy group received glucocorticoids on a tapering schedule with or without cyclophosphamide on the basis of a five-factor score ≥ 1. The primary endpoint was the proportion of patients who achieved remission, defined as the absence of EGPA disease activity (indicated by a BVAS of 0 at a prednisone dose of ≤ 7.5 mg/d), at 180 days. Secondary endpoints included the duration of remission, glucocorticoid dose, and safety, with follow-up visits scheduled up to 360 days. TAKEAWAY: At 180 days, 63.5% of patients in the rituximab group and 60.4% in the conventional group achieved remission (relative risk, 1.05; P = .75). At 360 days, remission rates were similar between the groups: 59.6% in the rituximab group and 64.2% in the conventional group. The time to remission was a median of 2 weeks in both the groups. Among patients who achieved a BVAS of 0, the mean duration of remission was comparable — 48.5 weeks for rituximab and 49.1 weeks for conventional therapy. No significant differences were observed in relapse rates or serious adverse event rates between the rituximab and conventional therapy groups. Infections and cardiovascular events were the most common serious adverse events. IN PRACTICE: 'On the basis of the results of this trial, the role of rituximab in the therapeutic management of EGPA has been updated,' the authors of the study wrote. 'In most of the study population with nonsevere EGPA, the lack of a clinically meaningful effect of rituximab in addition to the conventional strategy of glucocorticoids alone may appropriately inform clinical decision-making,' they added. SOURCE: The study was led by Benjamin Terrier, MD, PhD, Université Paris Cité in Paris, France. It was published online on July 28, 2025, in Annals of Internal Medicine. LIMITATIONS: The study's design as a superiority trial may not adequately address the equivalence between rituximab and conventional therapy. The limited sample size, due to the rarity of EGPA, affected the precision of subgroup analyses. The focus on remission induction in the vasculitis phase may differ from other studies. DISCLOSURES: The study was funded by research grants from the French Ministry of Health and sponsored by Assistance Publique-Hôpitaux de Paris. Additional disclosures are noted in the original article online. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
07-07-2025
- Health
- Medscape
Fast Five Quiz: Management of MPA
Microscopic polyangiitis (MPA) represents one category within the antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV), alongside granulomatosis with polyangiitis (GPA) and eosinophilic GPA (EGPA). MPA is associated with distinct presentations, organ involvement, and worse prognosis than EGPA and GPA; treatment strategies must be customized according to disease severity, affected organs, and individual patient characteristics. What do you know about the management of MPA? Check your knowledge with this quick quiz. Although renal involvement is common in ANCA vasculitis owing to a high concentration of blood vessels, subtypes of ANCA vasculitis have distinct patterns of extrarenal involvement. These varying clinical presentations correlate with different antibody profiles: MPA commonly associates with myeloperoxidase (MPO) serology while GPA generally presents with proteinase 3 (PR3) serology. Following renal involvement, the pulmonary system is a commonly involved organ system in MPA; cutaneous involvement and neurologic manifestations are also common. MPA typically shows fewer manifestations in the ear, nose, and throat region and eyes than other subtypes. Cardiovascular system and gastrointestinal system involvement are more often seen in EGPA, though patients with MPA can experience cardiovascular and gastrointestinal symptoms. Learn more about renal involvement in MPA. The latest Kidney Disease Improving Global Outcomes (KDIGO) and European Alliance of Associations for Rheumatology (EULAR) guidelines recommend beginning plasma exchange in patients with MPA when serum creatinine rises above > 300 µmol/L (equivalent to 3.4 mg/dL, as stated by KDIGO). This is supported by a recent meta-analysis that reported plasma exchange reduces the risk for end-stage kidney disease at 12 months; the same serum creatinine level for initiation was recommended by the researchers. However, they noted that plasma exchange was not found to improve the combined endpoint of "death and/or end-stage kidney disease." Additionally, KDIGO also recommends plasma exchange for patients requiring dialysis or those with diffuse alveolar hemorrhage and hypoxemia, but EULAR specifically recommends against routine use of plasma exchange for diffuse alveolar hemorrhage in patients with MPA and GPA. Learn more about creatinine monitoring in MPA. The latest KDIGO guidelines recommend considering discontinuation of immunosuppressive therapy in patients with MPA who have remained on dialysis for 3 months without extrarenal disease manifestations. This approach acknowledges that patients with MPO-ANCA-associated vasculitis (which is most strongly associated with MPA) who have kidney failure without involvement of other organs face minimal relapse risk. Supporting this, the EULAR cites research demonstrating that patients who are dependent on dialysis and in remission without immunosuppression are significantly more likely to experience serious infectious or cardiovascular complications from continued treatment than suffer disease recurrence; they specifically recommend weighing benefits and harms in continuing immunosuppressive therapy in the MPA subtype of ANCA. Learn more about immunosuppressive therapy in MPA. According to a recent review citing data from KDIGO, patients with MPA typically have the worst kidney prognosis due to the chronic damage associated with this subtype. Further, patients with EGPA less often have kidney involvement than GPA or MPA and usually have better kidney prognosis. Kidney prognosis is generally worse in patients with MPA than those with GPA as well. KDIGO also cites previously developed prognostic scoring systems (which include sclerotic, focal, crescentic, and mixed class), depending on most of the glomeruli histology. For example, focal class (> 50% normal glomeruli) is associated with a favorable outcome, while sclerotic class (≥ 50% sclerotic glomeruli) is associated with poorer outcomes. Learn more about prognosis in MPA. Both KDIGO and EULAR guidelines recommend a tapering schedule of 4-5 months after initiating glucocorticoids in patients with MPA, reaching a reduced dose (listed as " 5 mg prednisolone equivalent" per day) by that point. Tapering schedule is generally based on weight and disease severity. For example, for patients weighing > 75 kg (165 lb), EULAR suggests starting at 75 mg, then tapering to 40 mg by week 2, then lowering the dose by approximately 25% every 2 weeks until reaching 5 mg by week 19. This is the same tapering schedule recommended by KDIGO; the full tapering schedule for this weight and others can be found here. Clinical evidence supporting this strategy comes from the PEXIVAS trial, which demonstrated that lowering steroid exposure by 40% during the initial 6 months maintained therapeutic effectiveness while significantly decreasing serious infection rates compared to conventional dosing. This accelerated reduction strategy effectively balances inflammatory control with minimizing steroid-related complications. Learn more about glucocorticoids in MPA.
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Business Standard
30-05-2025
- Business
- Business Standard
AstraZeneca Pharma rises 2% on securing CDSCO nod for Benralizumab solution
AstraZeneca Pharma share price: Pharmaceutical company AstraZeneca shares rose as much as 2.14 per cent to hit an intraday high of ₹8,089 per share on the last trading day of the week i.e. Friday, May 30, 2025. At 1:30 PM, AstraZeneca Pharma shares were trading 1.26 per cent higher at ₹8,018.90 per share. By comparison, the BSE Sensex was trading 0.21 per cent lower at 81,461.57 levels. Why did AstraZeneca share price rise in trade today? AstraZeneca Pharma share price rose after it received approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import for sale and distribution of Benralizumab 30 mg/ml solution for injection (brand name: Fasenra) for an additional indication. In an exchange filing, AstraZeneca Pharma said, 'This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) for an additional indication.' Benralizumab is used as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Besides, the approval also paves way for the marketing of Benralizumab 30 mg/ml solution for injection (Brand name: Fasenra) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any. Earlier this week, AstraZeneca Pharma India secured approval from CDSCO to import for sale and distribution of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for an additional indication. Osimertinib as monotherapy is used in the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and whose disease has not progressed during or following platinum-based chemoradiation therapy AstraZeneca Pharma Q4 results The Board of Directors of AstraZeneca Pharma will meet today to consider and approve the March quarter of financial year 2025 (Q4FY25) and financial year 2025 (FY25) results, along with dividend for FY25, if any. About AstraZeneca Pharma AstraZeneca Pharma is a British-Swedish multinational pharmaceutical and biotechnology company, formed in 1999 through the merger of Sweden's Astra AB and Britain's Zeneca Group. The company is dedicated to developing and selling innovative medicines across various therapeutic areas, including cancer, cardiovascular diseases, gastrointestinal issues, infections, neuroscience, respiratory conditions, and inflammation. The company has had a major presence in India for 45 years. AstraZeneca Pharma India oversees manufacturing, sales, and marketing operations, while the company also gained global recognition for its role in developing the Oxford–AstraZeneca Covid-19 vaccine Leveraging data science and artificial intelligence (AI), AstraZeneca claims to boost the success rates and efficiency of its research and development (R&D) processes. The market capitalisation of AstraZeneca Pharma is ₹20,037.38 crore, according to BSE. The company falls under the BSE500 index. The 52-week high of AstraZeneca share price is ₹9,199, while its 52-week low is ₹5,415.55.
Business Standard
30-05-2025
- Business
- Business Standard
AstraZeneca Pharma gets CDSCO nod to import and distribute for Benralizumab solution in India
AstraZeneca Pharma India announced that it has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import, sell, and distribute Benralizumab Solution. Through this approval, Benralizumab is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This approval paves the way for the marketing of Benralizumab Solution for Injection (brand name Fasenra) in India for the specified additional indication, subject to the receipt of any related statutory approvals, if required. AstraZeneca Pharma India is engaged in the business of manufacture, distribution, and marketing of pharmaceutical products and also provides clinical trial services to an overseas group company. The companys standalone net profit surged to Rs 54.68 crore in Q3 FY25 as compared with Rs 15.80 crore in Q3 FY24. Revenue from operations jumped 44% to Rs 440.29 crore in Q3 FY25 as compared with Rs 305.79 crore in Q3 FY24. The scrip shed 0.10% to end at Rs 7,910.55 on the BSE.
Business Upturn
30-05-2025
- Business
- Business Upturn
AstraZeneca Pharma receives CDSCO nod for expanded use of Fasenra in India
By Aditya Bhagchandani Published on May 30, 2025, 09:25 IST AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Benralizumab (brand name: Fasenra) in India for an additional medical indication. The newly approved indication allows Fasenra to be used as an add-on treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This rare autoimmune condition is known to cause inflammation of blood vessels, leading to organ damage. AstraZeneca confirmed the development in a regulatory filing to the stock exchanges on May 29, 2025, under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements. The company stated that while the permission paves the way for marketing Fasenra in India for the newly approved indication, it remains subject to receipt of additional statutory clearances if required. Fasenra is already approved in India for other eosinophilic conditions, and this marks an important expansion in its therapeutic scope, potentially benefiting more patients with complex immunological diseases. 'The receipt of this permission paves way for the marketing of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) in India for the specified additional indication,' the company noted in the filing. The company secretary Manasa R signed off the communication to both BSE and NSE. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
