Latest news with #rituximab
Yahoo
5 days ago
- Business
- Yahoo
Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights
First patient treated in company-sponsored global basket trial exploring AlloNK® + rituximab in refractory rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis Continued execution and enrollment progress with over a dozen patients treated with AlloNK + mAb across over a dozen sites in company-sponsored and investigator-initiated clinical trials in autoimmune diseases Initial safety, translational data, and lead indication selection for AlloNK in autoimmune diseases to be presented by year-end 2025; initial clinical response data in the lead indication to be presented in 1H2026 Cash runway into Q2 2027, with cash, cash equivalents, and investments of $142.4 million as of June 30, 2025 SAN DIEGO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the second quarter ended June 30, 2025, and highlighted recent progress. 'We are making meaningful progress across our ongoing clinical trials exploring AlloNK® in autoimmune disease. We now have over a dozen sites enrolling across our trials in the US and have already treated over a dozen patients with AlloNK in combination with monoclonal antibodies across rheumatoid arthritis, SLE, lupus nephritis, Sjögren's disease, and systemic sclerosis,' said Fred Aslan, M.D., Chief Executive Officer of Artiva. 'By the end of 2025, we look forward to sharing initial translational data, supporting AlloNK's mechanism of action, and safety data, supporting the potential of our therapy, which includes the use of cyclophosphamide and fludarabine, to be administered and managed in an outpatient setting across multiple autoimmune indications. We also look forward to announcing our lead indication by the end of 2025, setting the stage to share initial clinical response data in that indication in the first half of next year.' Recent Business Highlights AlloNK® (also known as AB-101) Updates Over a dozen clinical sites active and enrolling across two company-sponsored trials in autoimmune diseases: the Phase 2a basket clinical trial and the Phase 1/1b clinical trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN) First patient treated with AlloNK + rituximab in recently initiated global Phase 2a company-sponsored basket clinical trial for refractory rheumatoid arthritis (RA), Sjögren's disease (SjD), idiopathic inflammatory myopathies (myositis, or IIM), and systemic sclerosis (scleroderma, or SSc) Over a dozen patients treated with AlloNK + monoclonal antibody (mAb) across refractory RA, SLE, LN, SjD, and SSc in the company-sponsored trials and an investigator-initiated basket trial Upcoming Milestones By Year-End 2025: Initial safety and translational data for AlloNK + mAb across multiple autoimmune diseases from ongoing clinical trials and disclosure of lead indication for further development Mechanistic and translational data for AlloNK in autoimmune diseases Insights into tolerability of AlloNK + mAb, and the patient journey in community rheumatology sites, including the potential ease of use of conditioning regimens with cyclophosphamide and fludarabine Disclosure of lead indication for AlloNK development in autoimmune diseases 1H 2026: Initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy Second Quarter 2025 Financial Results Cash, Cash Equivalents and Investments. As of June 30, 2025, Artiva had cash, cash equivalents, and investments of $142.4 million, which is expected to fund operations into Q2 2027 Research and Development Expenses. Research and development expenses were $17.9 million for the three months ended June 30, 2025, compared to $12.3 million for the three months ended June 30, 2024 General and Administrative Expenses. General and administrative expenses were $4.9 million for the three months ended June 30, 2025, compared to $3.9 million for the three months ended June 30, 2024 Other Income (expense), net. Other income, net, was $1.6 million for the three months ended June 30, 2025, compared to other expense, net, of $1.7 million for the three months ended June 30, 2024 Net Loss. Net loss totaled $21.3 million for the three months ended June 30, 2025, as compared to net loss of $17.8 million for the three months ended June 30, 2024, with non-cash stock-based compensation expense of $1.5 million for the three months ended June 30, 2025, and June 30, 2024 About Artiva Biotherapeutics Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva's lead program, AlloNK® (also known as AB-101), is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases including rheumatoid arthritis and Sjögren's disease, as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell's NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Artiva Biotherapeutics, Inc. (the 'Company') regarding the potential benefits, accessibility, ease of use, effectiveness, safety and mechanism of action of AlloNK; the Company's ability to advance AlloNK in autoimmune disease; the Company's ability to demonstrate progress and clinical validation of its approach; the Company's expectations regarding timing and availability of data from the Company's clinical trials or the basket IIT; the timing related to the selection of a lead autoimmune indication; the timing, likelihood or success of the Company's business strategy, as well as plans and objectives of management for future operations; and the Company's future results of operations and financial position, including cash runway. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), including the section titled 'Risk Factors' in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Artiva Biotherapeutics, Balance Sheets(Unaudited)(in thousands) June 30, 2025 December 31, 2024 Assets Cash, cash equivalents and investments $ 142,365 $ 185,428 Property and equipment, net 6,886 6,370 Operating and financing lease right-of-use assets 12,940 14,055 Other assets 7,200 3,728 Total assets $ 169,391 $ 209,581 Liabilities and stockholders' equity Accounts payable and accrued expenses $ 7,053 $ 8,513 Operating and financing lease liabilities 13,224 14,354 Other liabilities 73 73 Total liabilities 20,350 22,940 Stockholders' equity 149,041 186,641 Total liabilities and stockholders' equity $ 169,391 $ 209,581 Artiva Biotherapeutics, Statements of Operations and Comprehensive Loss(Unaudited)(in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 License and development support revenue $ - $ - $ - $ 251 Operating expenses: Research and development 17,861 12,333 34,914 23,488 General and administrative 4,949 3,857 10,068 7,444 Total operating expenses 22,810 16,190 44,982 30,932 Loss from operations (22,810 ) (16,190 ) (44,982 ) (30,681 ) Other income (expense), net Interest income 1,561 676 3,425 1,326 Change in fair value of SAFEs — (2,352 ) — (2,620 ) Other (expense) income, net (5 ) 23 (8 ) 169 Total other income (expense), net 1,556 (1,653 ) 3,417 (1,125 ) Net loss $ (21,254 ) $ (17,843 ) $ (41,565 ) $ (31,806 ) Net loss per share, basic and diluted $ (0.87 ) $ (22.00 ) $ (1.71 ) $ (39.24 ) Weighted-average common shares outstanding, basic and diluted 24,378,823 811,210 24,360,502 810,484 Comprehensive loss: Net loss $ (21,254 ) $ (17,843 ) $ (41,565 ) $ (31,806 ) Other comprehensive income (loss), net 2 (86 ) 131 (187 ) Comprehensive loss $ (21,252 ) $ (17,929 ) $ (41,434 ) $ (31,993 ) ContactsInvestors: Neha Krishnamohan, Artiva Biotherapeutics, Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@ Source: Artiva Biotherapeutics, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
5 days ago
- Health
- Medscape
Abatacept May Give Better Outcomes Than Rituximab in RA-ILD
TOPLINE: Among patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD), abatacept was linked to better outcomes, including a lower risk for mortality, hospitalization, or mechanical ventilation, than rituximab. METHODOLOGY: Researchers conducted a retrospective cohort study comparing the effectiveness and safety of abatacept vs rituximab for RA-ILD using an emulated target trial design, with data obtained from the TriNetX US Collaborative Network database. Adults diagnosed with RA-ILD who initiated abatacept treatment were propensity matched with those who initiated rituximab (n = 1615 in each treatment group) between January 2007 and June 2024. The primary outcome was all-cause mortality, and secondary outcomes included hospitalization, mechanical ventilation, medical utilization, and infection-related complications such as bacteremia and pneumonia. TAKEAWAY: Treatment with abatacept was associated with lower risk for all-cause mortality than treatment with rituximab (hazard ratio [HR], 0.689; 95% CI, 0.581-0.818) during the 5-year follow-up period. Additionally, abatacept treatment was associated with reduced risks for hospitalization (HR, 0.882; 95% CI, 0.776-0.977) and mechanical ventilation (HR, 0.698; 95% CI, 0.521-0.934). Patients receiving abatacept had a lower incidence of pneumonia than those receiving rituximab (HR, 0.858; 95% CI, 0.754-0.977); however, the risk for bacteremia remained comparable between the groups. Abatacept users demonstrated significantly reduced risks for cyclophosphamide use (HR, 0.162; 95% CI, 0.090-0.291) and immunoglobulin use (HR, 0.232; 95% CI, 0.157-0.343). IN PRACTICE: 'This large, real-world target-trial emulation strengthens the evidence that abatacept may offer a more favorable outcome than rituximab in RA-ILD, with consistently lower risks of all-cause mortality across the subgroup and sensitivity analyses. By providing the first head-to-head comparison of these two biologics, the study provides a critical evidence gap in RA-ILD management,' the authors wrote. SOURCE: The study was led by Po-Cheng Shih, MD, Chung Shan Medical University, Taichung, Taiwan. It was published online on July 22, 2025, in Arthritis & Rheumatology. LIMITATIONS: Despite extensive matching, residual confounding by indication and unmeasured factors (eg, detailed smoking history, RA activity scores, and imaging-based ILD severity) may have existed. ILD diagnoses relied on diagnostic codes without direct radiologic or full pulmonary function confirmation, which may have led to misclassification. As this was a retrospective observational US-based study, causality could not be definitively established, and the findings may not be generalizable to other settings internationally. DISCLOSURES: No funding was received for this study. The authors reported having no relevant conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Globe and Mail
16-06-2025
- Health
- Globe and Mail
Dermatomyositis Market Set to Advance with Improved Diagnosis and Emerging Immunotherapies by 2034
Dermatomyositis is a rare, chronic, inflammatory myopathy characterized by progressive muscle weakness and distinctive skin rashes, often associated with autoimmune mechanisms. It can occur in both adults and children and may involve complications such as interstitial lung disease, malignancy, and calcinosis. Despite its rarity, dermatomyositis remains a significant clinical concern due to its multisystem involvement, diagnostic complexity, and limited treatment options. DelveInsight's ' Dermatomyositis Market Insight, Epidemiology, and Market Forecast – 2034 ' provides an in-depth analysis of the current landscape and future outlook of the DM market across major geographies, including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. The report explores detailed epidemiological trends, segmentation by age and clinical subtypes, and diagnostic challenges that contribute to underreporting and delayed intervention. Current treatment regimens typically include corticosteroids, immunosuppressants (methotrexate, azathioprine), intravenous immunoglobulin (IVIG), and emerging biologics like rituximab. However, response rates vary, and long-term use can lead to significant side effects. A growing pipeline of investigational agents—targeting pathways such as type I interferons and B-cell modulation—offers promising avenues for disease-specific and steroid-sparing therapies. The Dermatomyositis market is projected to witness steady growth through 2034, fueled by increased disease recognition, clinical trial activity, and strategic advancements by pharmaceutical companies. Biotech firms and academic institutions are exploring novel immunomodulatory agents and precision medicine approaches to improve outcomes in both adult and pediatric populations. DelveInsight's report is an essential resource for pharmaceutical executives, clinical researchers, investors, and healthcare professionals who seek strategic insights into the evolving DM landscape, from market dynamics and unmet needs to the competitive pipeline shaping the future of dermatomyositis care. Some of the Key Facts of the Dermatomyositis Market Report: • In 2023, the dermatomyositis market in the 7MM was valued at approximately USD 187 million, and is projected to grow at a CAGR of 16.8% due to improved disease awareness, diagnostics, and the introduction of new therapies. • The U.S. had the highest number of diagnosed cases, with around 38.5K in 2023. • Across the 7MM, there were nearly 72K diagnosed prevalent cases in 2023, with 91% in adults and 9% in juveniles. • The U.S. accounted for ~54% of total diagnosed cases, while EU4 and the UK represented about 29%, and Japan ~17%. • In January 2025, RESTEM announced that the FDA granted Fast Track designation for its Restem-L program, using umbilical cord outer lining stem cells (ULSCs) to treat Polymyositis and Dermatomyositis (PM/DM), now classified as Idiopathic Inflammatory Myopathy (IIM). This follows the recent Orphan Drug Designation for Restem-L in IIM. • In July 2024, Priovant Therapeutics announced the completion of enrollment for its Phase 3 VALOR trial evaluating brepocitinib in dermatomyositis. With 241 participants across 90 sites on four continents, it is the largest interventional trial ever conducted for the condition. • Leading companies in the Dermatomyositis market include Kezar Life Sciences, Argenx, Pfizer, CSL Behring, Viela Bio, PAEAN Biotechnology, Alexion Pharmaceuticals, and others. • Emerging acute Dermatomyositis drugs include KZR-616, EFG PH20, PF 06823859, Hizentra, Daxdilimab, PN 101, Ravulizumab, and others. • The increasing prevalence of dermatomyositis and ongoing advancements in therapeutic options are driving the demand for more effective treatment approaches. To know in detail about the dermatomyositis market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: Dermatomyositis Market Forecast Dermatomyositis Overview Dermatomyositis is a rare, systemic autoimmune disorder characterized by chronic inflammation of the skin and muscles. It presents with hallmark features such as symmetric proximal muscle weakness and distinctive skin rashes, including the heliotrope rash and Gottron's papules. The condition may also affect other organs, including the lungs, esophagus, and heart, and is sometimes associated with malignancy, especially in adults. Dermatomyositis affects both adults and children (juvenile dermatomyositis), with varying severity. Its exact etiology remains unclear but is believed to involve a combination of genetic predisposition, immune system dysregulation, and environmental triggers. Diagnosis typically involves a combination of clinical findings, elevated muscle enzymes, electromyography (EMG), imaging studies, skin/muscle biopsies, and autoantibody testing. Management of dermatomyositis requires a multidisciplinary approach, involving dermatologists, rheumatologists, neurologists, and physical therapists. While there is no cure, a range of therapies aim to control inflammation, alleviate symptoms, and prevent complications. Get a free sample of the dermatomyositis market report with key insights and emerging therapies here: Dermatomyositis Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Dermatomyositis Epidemiology Segmentation: The Dermatomyositis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by: • Diagnosed Dermatomyositis prevalence • Type-specific Diagnosed Dermatomyositis prevalence • Age-specific Diagnosed Dermatomyositis prevalence • Gender-specific Diagnosed Prevalent Cases of Dermatomyositis • Severity-specific Diagnosed Prevalent Cases of Dermatomyositis • Chronicity-specific Diagnosed Prevalent Cases of Dermatomyositis Download the report to understand which factors are driving dermatomyositis epidemiology trends @ Dermatomyositis Epidemiology Forecast Dermatomyositis Drugs Uptake and Pipeline Development Activities The Dermatomyositis drugs uptake section examines the rate at which newly launched or upcoming potential drugs are being adopted in the Dermatomyositis market during the study period. This analysis covers drug uptake, patient adoption of therapies, and the sales performance of each drug. Additionally, the therapeutics assessment section highlights the drugs with the most rapid uptake, shedding light on the factors driving their widespread use. It also provides a comparative analysis of these drugs based on their market share. The report further delves into the Dermatomyositis pipeline development activities, offering key insights into various therapeutic candidates in different stages of development and the major companies behind these innovations. It also covers recent collaborations, acquisitions, mergers, licensing agreements, patent details, and other critical information related to emerging therapies. Dermatomyositis Market Outlook While there is no definitive cure for dermatomyositis, available treatments aim to reduce inflammation, control symptoms, and improve quality of life. The approval of OCTAGAM and the development of multiple clinical management guidelines—such as those from the British Society for Rheumatology and the Japanese Society of Rheumatology—have significantly shaped and standardized the therapeutic landscape. Treatment often begins with corticosteroids to manage muscle inflammation, followed by immunosuppressants or immunomodulators like methotrexate, azathioprine, or mycophenolate mofetil to reduce steroid dependency. For resistant or severe cases, advanced therapies such as rituximab, IVIG, and calcineurin inhibitors are employed. In terms of skin manifestations, management includes both topical agents (e.g., corticosteroids, calcineurin inhibitors) and systemic medications like hydroxychloroquine. Adjunctive strategies such as physiotherapy, sun protection, and dietary interventions are also integral. A growing pipeline featuring therapies like Brepocitinib (Priovant/Pfizer), Dazukibart (Pfizer), Efgartigimod (Argenx), and SAPHNELO (AstraZeneca) reflects an evolving research focus on immunomodulation and interferon signaling pathways. These emerging agents, combined with better diagnostics and increasing disease awareness, are expected to drive market growth through 2034. Dermatomyositis Market Strengths • A strong research focus on immune pathways (e.g., JAK-STAT, interferon) has led to promising investigational drugs such as Brepocitinib and Anifrolumab, indicating future therapeutic breakthroughs. • Increasing awareness among clinicians and availability of diagnostic tools (e.g., autoantibody profiling, MRI) enable earlier diagnosis and more tailored treatment strategies. Dermatomyositis Market Weaknesses • Despite multiple treatment options, none offer a cure, and many patients experience relapses or partial responses, necessitating lifelong management. • A significant portion of treatment regimens relies on off-label drug use, which lacks robust clinical trial data, leading to variable efficacy and safety outcomes across patient populations. Scope of the Dermatomyositis Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] • Key Dermatomyositis Companies: Kezar Life Sciences, Argenx, Pfizer, CSL Behring, Viela Bio, PAEAN Biotechnology, Alexion Pharmaceuticals, and others. • Key Dermatomyositis Therapies: KZR-616, EFG PH20, PF 06823859, Hizentra, Daxdilimab, PN 101, Ravulizumab, and others. • Dermatomyositis Therapeutic Assessment: Dermatomyositis, currently marketed, and Dermatomyositis emerging therapies • Dermatomyositis Market Dynamics: Dermatomyositis market drivers and Dermatomyositis market barriers • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies • Dermatomyositis Unmet Needs, KOL's views, Analyst's views, Dermatomyositis Market Access and Reimbursement To learn more about the key players and advancements in the dermatomyositis treatment landscape, visit the Dermatomyositis Market Analysis Report Table of Contents 1. Dermatomyositis Market Report Introduction 2. Executive Summary for Dermatomyositis 3. SWOT analysis of Dermatomyositis 4. Dermatomyositis Patient Share (%) Overview at a Glance 5. Dermatomyositis Market Overview at a Glance 6. Dermatomyositis Disease Background and Overview 7. Dermatomyositis Epidemiology and Patient Population 8. Country-Specific Patient Population of Dermatomyositis 9. Dermatomyositis Current Treatment and Medical Practices 10. Dermatomyositis Unmet Needs 11. Dermatomyositis Emerging Therapies 12. Dermatomyositis Market Outlook 13. Country-Wise Dermatomyositis Market Analysis (2020–2034) 14. Dermatomyositis Market Access and Reimbursement of Therapies 15. Dermatomyositis Market Drivers 16. Dermatomyositis Market Barriers 17. Dermatomyositis Appendix 18. Dermatomyositis Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefit from market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Jatin Vimal Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Medscape
12-05-2025
- Health
- Medscape
Rituximab Shows Long-Term Benefits in Follicular Lymphoma
Early rituximab monotherapy led to a substantial delay in the need for new treatment in patients with advanced stage, asymptomatic, low tumour burden follicular lymphoma. After a median follow-up duration of 14.7 years, researchers found no detrimental effect on the time to initiation of second new treatment or overall survival. METHODOLOGY: Researchers conducted an open-label, randomised, phase 3 trial in which 455 patients with asymptomatic, stage II-IV, grade 1-3a low tumour burden follicular lymphoma were randomly assigned in a 1:1:1 ratio to the watchful waiting (n = 183), rituximab induction (n = 82), or rituximab maintenance (n = 190) group. Rituximab induction comprised 375 mg/m 2 intravenous doses weekly for 4 weeks, and the rituximab maintenance group received additional 12 doses every 8 weeks at the same dose. intravenous doses weekly for 4 weeks, and the rituximab maintenance group received additional 12 doses every 8 weeks at the same dose. The primary endpoint was the time to initiation of new treatment (TTNT), defined as the time from randomisation until the first day of systemic chemotherapy or radiotherapy initiation. This study reported long-term results of the trial over a median follow-up duration of 14.7 years. TAKEAWAY: At 15 years, 65% (95% CI, 56-72) of patients in the rituximab maintenance group, 48% (95% CI, 36-60) of patients in the rituximab induction group, and 34% (95% CI, 27-42) of patients in the watchful waiting group had not started new treatment. The median TTNT was 5.6 years (95% CI, 3.8-8.4) in the watchful waiting group, 14.8 years (95% CI, 7.5 to not reached) in the rituximab induction group, and not reached (95% CI, 15.6 to not estimable) in the rituximab maintenance group. The TTNT was significantly longer for patients in both rituximab groups than for those in the watchful waiting group (rituximab induction vs watchful waiting: hazard ratio [HR], 0.55; 95% CI, 0.38-0.80; P = .0019; rituximab maintenance vs watchful waiting: HR, 0.36; 95% CI, 0.26-0.50; P < .0001). = .0019; rituximab maintenance vs watchful waiting: HR, 0.36; 95% CI, 0.26-0.50; < .0001). No significant differences in overall survival were observed between the groups at 15 years (rituximab maintenance, 73%; rituximab induction, 66%; and watchful waiting, 68%). Similarly, no significant differences in the risk for high-grade transformation and the time to initiation of second new treatment were observed between the groups. IN PRACTICE: "Early rituximab monotherapy could therefore be considered a standard treatment option for patients with advanced stage, asymptomatic low tumour burden follicular lymphoma and the optimal approach should be considered on an individual patient basis," the authors concluded. SOURCE: This study was led by Michael Northend, University College London Hospitals NHS Foundation Trust, London, England. It was published online in The Lancet Haematology . LIMITATIONS: This study was limited by the lack of long-term toxicity data, especially for patients receiving rituximab maintenance, and the early closure of the rituximab induction group, which limited the power of any comparisons with the four-dose rituximab induction regimen. DISCLOSURES: This study received funding from Cancer Research UK, the Lymphoma Research Trust, Lymphoma Action, and Roche. Roche provided rituximab free of charge. Additional disclosures are noted in the original article. Several authors reported receiving honoraria and consultancy fees and having other ties with various sources.
Medscape
12-05-2025
- Health
- Medscape
Prophylaxis in Vasculitis Cuts Risk for Non-PJP Infections
Prophylactic treatment with trimethoprim-sulfamethoxazole (TMP-SMX) significantly reduced the risk for serious infections by approximately 50% in patients with antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis, with the greatest benefits observed during the first 180 days of treatment. METHODOLOGY: Researchers conducted an observational study that used a target trial emulation framework to examine the effect of prophylactic TMP-SMX on the incidence of serious infections in patients with ANCA-associated vasculitis. They included 296 patients with new-onset or relapsing ANCA-associated vasculitis from four tertiary referral hospitals in South Korea who received either rituximab or cyclophosphamide as induction therapy between 2005 and 2023. Of these, 240 patients received TMP-SMX prophylaxis (prophylaxis group; mean age, 63.7 years; 55.8% women) within 14 days of induction therapy, and 56 patients did not receive prophylaxis (control group; mean age, 61.5 years; 60.7% women) during the same period. Physicians at each institution determined patient eligibility for prophylactic TMP-SMX, with dosage being either one single-strength tablet (TMP 80 mg and SMX 400 mg) daily or one double-strength tablet (TMP 160 mg and SMX 800 mg) every other day, adjusted for renal function. The primary outcome was the incidence of serious infections requiring intravenous antimicrobial treatment, hospitalization, or extended hospital stay. Secondary outcomes included infection-related deaths and severe adverse drug reactions related to TMP-SMX. TAKEAWAY: Approximately 45.8% of patients discontinued the use of prophylactic TMP-SMX within the first 180 days. During 252.1 person-years of observation, 77 serious infections occurred in 65 patients, with an incidence rate of 30.5 per 100 person-years and a fatality rate of 18.5%. Most serious infections (85.7%) occurred within the first 180 days of observation (incidence rate ratio, 5.43; 95% CI, 2.87-10.28). The prophylaxis group had a significantly lower 1-year incidence than the control group (hazard ratio [HR], 0.48; 95% CI, 0.32-0.72), particularly during the first 180 days (HR, 0.41; 95% CI, 0.22-0.76) but not thereafter (HR, 3.76; 95% CI, 0.46-29.43). Infection-related mortality was also significantly lower in the prophylaxis group than in the control group (HR, 0.23; 95% CI, 0.10-0.53). Over 127.4 person-years of TMP-SMX prophylaxis, 35 cases of adverse events occurred, eight of which were adverse drug reactions related to prophylactic TMP-SMX, and 27 patients discontinued TMP-SMX. Only one case of severe adverse drug reaction was noted, which was resolved after treatment discontinuation. IN PRACTICE: 'Our results strongly suggest that prophylactic TMP-SMX provides additional benefits in patients with AAV [ANCA-associated vasculitis] beyond reducing the risk of PJP [ Pneumocystis jirovecii pneumonia],' the authors wrote. SOURCE: This study was led by Yun Kyu Kim, MD, Seoul National University College of Medicine, Seoul, Republic of Korea, and was published online on April 14, 2025, in Arthritis & Rheumatology . LIMITATIONS: Unmeasured confounders, such as compliance with prophylactic TMP-SMX, may have influenced the findings. The varied duration of TMP-SMX use in the prophylaxis group, with many patients discontinuing within 180 days, may have led to biased estimates. Additionally, the impact of TMP-SMX on COVID-19 incidence and related infectious complications could not be estimated for patients with an index date prior to 2018. DISCLOSURES: This study was supported by a grant from the National Research Foundation of Korea. One author reported receiving salary from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Two authors reported receiving grants and consulting fees from various pharmaceutical companies.
