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Vabysmo data suggest rapid and robust drying of retinal fluid in patients with wet age-related macular degeneration and diabetic macular edema Real-world studies of Vabysmo demonstrate ability to extend treatment intervals in the first four months while maintaining visual acuity Clinical data on an investigational anti-interleukin-6 treatment in uveitic macular edema (UME) will be presented for the first time SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which will be held from April 23-27 in New Orleans, LA. The abstracts showcase the strength of Genentech’s Ophthalmology portfolio, including post-hoc data from Phase III Vabysmo® (faricimab-svoa) studies that support its benefit in drying retinal fluid in wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Real-world data on Vabysmo treatment patterns and outcomes will also be presented, as well as approaches to personalized healthcare that include the use of artificial intelligence (AI) modeling to predict retinal disease progression. Additionally, Phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME. “The breadth of data we are presenting at ARVO demonstrates our sustained commitment to preserving vision for people with potentially blinding retinal conditions,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are particularly encouraged by data indicating that Vabysmo may stabilize blood vessels and reduce fluid in the retina. Fluid control is essential for optimal central vision used for everyday activities such as reading and driving.” The following data will be presented at ARVO 2023: Vabysmo improves drying for people with wet AMD and DME A post-hoc analysis from the head-to-head dosing period of the Phase III TENAYA and LUCERNE studies suggests Vabysmo results in greater drying of retinal fluid compared to aflibercept in people with wet AMD. The data include change in central subfield thickness (CST), absence of subretinal and intraretinal fluid (SRF and IRF) and time to absence of SRF and IRF. A post-hoc analysis from the head-to-head dosing period of the Phase III YOSEMITE and RHINE studies also supports the positive impact of Vabysmo on macular blood vessel leakage compared to aflibercept in people with DME. Outcomes include macular leakage area and the proportion of patients with minimal to no macular leakage - two important markers of vascular stability. Another analysis from YOSEMITE and RHINE suggests Vabysmo reduces retinal fluid when compared to aflibercept in people with DME. The data include time to absence of DME (CST <325 µm) and time to absence of IRF. Vabysmo extends dosing intervals early in the real-world Two Vabysmo real-world studies in wet AMD and DME show patients extended their dosing intervals early in their treatment while maintaining or improving their vision. The majority of patients were able to extend their treatment intervals during the four initial doses. Treatment intervals were categorized as “extended” if any interval was more than six weeks apart. Investigational IL-6 monoclonal antibody may benefit people with UME Phase I data on an IL-6 inhibitor that is in development for UME and other retinal conditions suggest that this investigational monoclonal antibody improves visual acuity and CST in patients with UME. The IL-6 pathway plays an important role in the development and progression of UME by promoting blood vessel leakage and inflammation. UME is a complication of uveitis, a form of eye inflammation. This results in accumulation of fluid in the macula and can lead to significant visual impairment and vision loss. About 750,000 patients have uveitis in the U.S. and approximately one-third are impacted by UME. Genentech recently launched two Phase III trials in UME based on encouraging Phase I safety and efficacy data. The first patients have been treated in the Meerkat (NCT05642312) and Sandcat (NCT05642325) studies, which are evaluating the safety and efficacy of the monoclonal antibody in people with UME. Genentech is also studying the IL-6 inhibitor in DME. AI and machine learning in retina Genentech will also present research related to the diagnosis and treatment of retinal conditions. These presentations include new research on the use of AI and machine learning to predict disease progression in geographic atrophy, a progressive and irreversible form of AMD; enable timely and accurate assessment of disease activity in wet AMD or DME; predict treatment response in DME; and investigate new imaging biomarkers in diabetic retinopathy. Further information on select Genentech abstracts that will be presented at ARVO 2023 can be found in the table below. Follow Genentech on Twitter @Genentech and @GenentechEye and via LinkedIn, and keep up to date with ARVO Annual Meeting news and updates by using the hashtag #ARVO23. Topic Abstract Title Presentation Number /Presentation Details Vabysmo Faricimab rapidly improves fluid outcomes in patients with neovascular age-related macular degeneration Poster Number: C0138 Session: 123 April 24 3:15 PM to 5:15 PM CDT Efficacy, durability, and safety of faricimab in diabetic macular edema (DME): 1-year results from China subpopulation of phase 3 RHINE trial Poster Number: B0522 Session: 148 April 25 8:45 AM to 10:30 AM CDT Faricimab causes rapid and sustained intraocular suppression of Ang-2 and VEGF-A for up to 16 weeks in neovascular age-related macular degeneration and diabetic macular edema Poster Number: B0455 Session: 146 April 25 8:45 AM to 10:30 AM CDT Durable vision gains and greater fluid control with extended faricimab dosing versus aflibercept in patients with diabetic macular edema #2815 oral presentation Session: 153 April 25 12:45 PM to 1:00 PM CDT Faricimab reduces macular leakage vs aflibercept in patients with DME #2816 oral presentation Session: 153 April 25 1:00 PM to 1:15 PM CDT Faster time to retinal fluid control with faricimab in patients with DME in the Phase 3 YOSEMITE/RHINE trials #2817 oral presentation Session: 153 April 25 1:15 PM to 1:30 PM CDT Individualized faricimab dosing up to every 16 weeks maintains robust anatomic and vision outcomes through 2 years in nAMD #5056 oral presentation Session: 271 April 27 10:45 AM to 11:00 AM CDT Uveitic Macular Edema A novel intravitreal anti-IL-6 monoclonal antibody for uveitic macular edema (UME): preliminary results from the phase 1 DOVETAIL study #5100 oral presentation Session: 277 April 27 11:30 AM to 11:45 AM CDT A novel anti-IL-6 monoclonal antibody leads to restoration of IL-6-mediated endothelial barrier breakdown Poster Number: B0163 Session: 284 April 27 10:30 AM to 12:15 PM CDT Real World Evidence FARETINA-AMD: Patient characteristics and initial clinical response of patients with neovascular age-related macular degeneration treated with faricimab in the IRIS Registry Poster Number: C0171 Session: 124 April 24 3:15 PM to 5:00 PM CDT FARETINA-DME Patient characteristics and initial clinical response of patients with diabetic macular edema treated with faricimab in the IRIS Registry Poster Number: B0521 Session: 148 April 25 8:45 AM to 10:30 AM CDT Susvimo Port delivery system with ranibizumab in the treatment of diabetic retinopathy without center-involved diabetic macular edema: primary analysis results of the Phase 3 Pavilion trial. #3754 oral presentation Session: 205 April 26 11:00 AM to 11:15 AM CDT AI/Personalized Healthcare Deep learning to predict future region of growth of geographic atrophy from fundus autofluorescence images Poster Number: C0218 Session: 21 April 23 8:00 AM to 9:45 AM CDT Predicting geographic atrophy growth rate with clinical and derived imaging features Poster Number: C0211 Session: 67 April 23 3:45 PM to 5:30 PM CDT Optical coherence tomography segmentation of retinal fluids using deep learning Poster Number: C0212 Session: 67 April 23 3:45 PM to 5:30 PM CDT Deep learning segmentation of foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) of non-proliferative diabetic retinopathy Poster Number: C0218 Session: 67 April 23 3:45 PM to 5:30 PM CDT A pilot study of machine learning models for prediction of treatment response in patients with diabetic macular edema in a Phase II clinical trial Poster Number: C0219 Session: 67 April 23 3:45 PM to 5:30 PM CDT About Wet Age-Related Macular Degeneration Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading, and is a leading cause of blindness for people aged 60 and over in the U.S. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss. Approximately 20 million people in the U.S. have some form of AMD, and of those, about 1.5 million have late-stage AMD which includes wet AMD. Wet AMD is caused by growth of abnormal blood vessels, also referred to as choroidal neovascularization (CNV), into the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years. About Diabetic Macular Edema Affecting approximately 750,000 people in the U.S., diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases. About the Vabysmo® (faricimab-svoa) Clinical Development Program Genentech has a robust Phase III clinical development program for Vabysmo. The program includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in wet, or neovascular, macular degeneration (AMD), and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME). In addition, Genentech is investigating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion in two Phase III studies, BALATON and COMINO.Genentech has also initiated several Phase IV studies, including the Elevatum study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo in a subpopulation of wet AMD highly prevalent in Asia, as well as the VOYAGER study, a global real-world data collection platform. Genentech also supports several other independent studies to further understand retinal conditions with a high unmet need. About Vabysmo® (faricimab-svoa) Vabysmo (faricimab-svoa) is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. Vabysmo U.S. Indications Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD) and diabetic macular edema (DME). Important Safety Information Contraindications Vabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo. Warnings and Precautions Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye. Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the injection. Although not common, Vabysmo patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with Vabysmo reported such an event. Adverse Reactions The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and blood on the white of the eye (conjunctival hemorrhage, 7%). These are not all the possible side effects of Vabysmo. Pregnancy, Lactation, Females and Males of Reproductive Potential Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo. It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo. Patients may report side effects to the FDA at (800) FDA-1088 or . Patients may also report side effects to Genentech at (888) 835-2555. Please see additional Important Safety Information in the full Vabysmo Prescribing Information or visit . About Genentech in Ophthalmology Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit . View source version on businesswire.com: Contacts Media Contact: Shirley Dang, (650) 467-6800 Advocacy Contact: Danielle Haney, (240) 805-4810 Investor Contacts: Loren Kalm, (650) 225-3217 Bruno Eschli, +41 61 687 5284 Source: Genentech View this news release online at:

Effect of improving blood pressure in patients with high blood pressure and diabetes Announced at the 13th International Symposium on Ginseng 2022 SEOUL, South Korea, Oct. 31, 2022 /PRNewswire/ -- Experts who have conducted scientific studies on the effect of ginseng gathered in Seoul from all around the world. The Korean Society of Ginseng (chaired by Lee Man-hui) said that the 13th International Symposium on Ginseng took place from the 25th to the 28th at Lotte Hotel Seoul. Professor Seikwan Oh's team from College of Medicine, Ehwa Women's University verifies that red ginseng improves memory loss and learning ability Continue Reading The 13th International Symposium on Ginseng 2022 According to the findings of a research study in 2022, red ginseng improves the memory loss associated with post-traumatic stress disorder (PTSD) [1] Post-traumatic stress disorder is stress-induced memory impairment accompanying neuroinflammation. Professor Seikwan Oh's team (joint researcher: Bombi Lee from College of Oriental Medicine, Kyunghee University) conducted a passive avoidance test and Morris water maze test on 48 rats six to eight weeks old (experiment rats), divided in six groups, to verify their learning and spatial cognition abilities after giving a constant one-time stress and injecting red ginseng extract 20, 50, 100mg/kg/1day for 14 days. The results showed the stressed rats lagged when escaping from the maze, whereas the red ginseng-injected group escaped from the maze at a similar speed to the unstressed group. They also checked the figures of various stress-induced inflammatory cytokines. Red ginseng appeared to reduce interleukin-6 (IL-6) and interleukin-8 (IL-8), which are markers of stress-induced inflammation, while increasing interleukin-12 (IL-12), which is the marker of anti-inflammation that suppresses inflammation. In addition, the red ginseng-injected group showed no increase in NF-kB, which increased and caused inflammation in the hippocampus of stressed group, and the generation of mRNA, which is the growth factor of deteriorated cranial nerves, was recovered by 252.51% after injection of red ginseng (p < 0.05). The team also disclosed the effect of red ginseng on age-related memory impairment (2015). They injected red ginseng extract (approx. 200/kg/1 day) into 32 18-month-old mice divided in four groups for three months after inducing cognitive impairment, and then conducted the Y-maze test to assess the effect on the spatial cognition ability and Morris water maze test to assess the spatial cognition and learning abilities. The result showed red ginseng represses age-related learning and memory failure. The findings verified the anti-dementia effect using the aged experiment animals that had memory failure amid continuous increase in dementia among the aged. Professor Hyong Young Kwon's team from Soonchunhyang University verifies that ginseng (ginsenoside Rd) suppresses muscle loss Published in the Journal of Cachexia, Sarcopenia and Muscle (JCSM) [2] with IF of 12.91(as of 2022) Professor Hyong Young Kwon's team from Soonchunhyang University said they verified the impact of ginsenoside Rd on muscle cells and effect of strengthening muscles, and identified the action mechanism. The findings were published in the Journal of Cachexia, Sarcopenia and Muscle, 2022, which has an impact factor (IF) of 12.91. The IF is an index figure used to compare and assess the relative importance of journals. Researches published in a journal of IF 10 or higher are regarded highly reliable. Muscle atrophy is a general degenerative disease which is caused by muscle loss and hypofunction, and can cause various cardiovascular diseases, cancers, blood poisoning, obesity and depression. According to the results of research by professor Hyong Young Kwon's team, the muscle strength of aged mice injected with ginsenoside Rd improved with time to a level similar to that of the general adult mice. Also, their muscle cell C2C12 grew bigger than the control group and the number of nuclei per cell increased from 20% to 37% in over six nuclei. Such effects appeared the same in muscle atrophy caused by steroid administration as well. The team also identified the mechanism that ginsenoside Rd grows the size of muscle cells by reducing active oxygen within muscle cells increased by TNF-α, the gene that induces inflammation. Ginsenoside Rd grew the size of muscle cells and induced the cell fusion by activating pAKT, which is the pathway essential for protein synthesis of muscle cells and reducing MuRF1 which promotes proteolysis. In addition, they implied that ginsenoside Rd can be utilized to prevent and treat cancer cachexia-led muscle atrophy by showing that it reduces phosphorylation, atrogin-1 and MuRF-1* that cause inflammation and induce muscle loss activated by TNF-α and interferon-gamma (IFNg), which cause inflammation when cancer cells proliferate or spread. Such effect of ginsenoside Rd in suppressing muscle loss also appeared in a cell test using human skeletal muscle cells (HSkM), the same as in the animal cells. Professor Narayanan's team from University of Michigan verifies that red ginseng prevents bone loss by keeping balance in intestinal microorganisms [3] The intestinal microbiota is an important controller for bone health. Intestinal microorganisms unbalanced or reduced in variety and number by extensive antibiotic treatment can bring bone loss, and it is known that bones are healthy when the intestinal microorganisms vary in types. The professor's team injected a broad-spectrum antibiotic into 21 adult male mice divided into four groups for two weeks, and then for four weeks injected water into one group and red ginseng extract 500mg/kg/1day into another group. As a result, the variety of intestinal microorganisms of mice decreased significantly after the injection of antibiotic, but it was significantly suppressed in the red ginseng-injected group, along with suppression of barrier damage. In addition, bone loss occurred considerably in femur and spine of mice, but this was prevented in the red ginseng-injected group. Professor Vuksan's team from Canada verifies that ginseng improves blood pressure of patients with high blood pressure and diabetes, and is safe for consumption by the patients [4] Professor Vuksan's team from Canada conducted a clinical test on 80 patients with Type 2 diabetes and high blood pressure for 12 weeks, and found the center systolic blood pressure significantly reduced in the group administered with Korean red ginseng and American ginseng in parallel after 12 weeks (reduction by 3.98±2 mmHg, p=0.04). Above this, there was no significant change in the pulse wave velocity and reactive hyperemia index which are used to assess the function of blood vessels. Accordingly, it confirmed that ginseng can improve the center systolic blood pressure of diabetic patients when administered auxiliary, apart from medication, without directly affecting the function of blood vessels. Moreover, professor Seo Sang-hee's team from Chungnam University presented that ginseng improves immunity against the infection of COVID 19 and enhances immunity with time. Researchers from other countries also revealed their research findings on various effects of ginseng and red ginseng. Such as Professor Tianshi Wang's team from Shanghai Jiao Tong University, China. They unveiled the effect of ginsenoside Rh1, one of the active ingredients of red ginseng, in suppressing the risk of metastasis of breast cancer. [Reference] * STAT3 phosphorylation, atrogin-1, MuRF-1 STAT3 (signal transducer and activator of transcription-3), atrogin-1 and MuRF-1(muscle ring finger=1) are proteins that promote the generation of various genes within cells, and atrogin-1 and MuRF-1 are especially involved in muscle cell fusion and differentiation. SOURCE The Korean Society of Ginseng

May 27, 2022 13:00 UTC Anifrolumab is a first-in-class type I interferon receptor antibody WILMINGTON, Del.--(BUSINESS WIRE)-- The first patients have been dosed in the IRIS Phase III clinical trial of anifrolumab in lupus nephritis (LN). Up to 60% of patients with lupus develop kidney involvement. In more severe cases, this can develop into LN.1 LN is characterized by kidney inflammation and is one of the most common severe organ manifestations in systemic lupus erythematosus (SLE),2 a chronic and complex autoimmune disease in which the immune system attacks healthy tissue in the body.3 Patients with LN are at a substantial increased risk of dialysis and early mortality.4-6 Patients with LN have been shown to have elevated levels of type I interferons in the blood and kidneys.7,8 Eduardo Mysler, Medical Director and Rheumatologist at the Organización Médica de Investigación, Buenos Aires, Argentina, and the international coordinating investigator in the anifrolumab clinical development program for LN, said, “The Phase II results of anifrolumab in lupus nephritis provided important evidence suggesting that blocking type I interferons is a potentially promising strategy for the treatment of lupus nephritis. I look forward to contributing to the next phase of anifrolumab’s development in this severe and often debilitating complication of lupus where new therapeutic options are needed.” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Lupus nephritis continues to represent a significant burden to patients worldwide. Following the approval of anifrolumab as the first new treatment for systemic lupus erythematosus in over a decade, the start of our IRIS Phase III trial in lupus nephritis is another important step forward in our ambition to bring anifrolumab to more patients with diseases where type I interferon is a central driver.” Results from the TULIP-LN1 Phase II proof of concept, dose-finding trial of anifrolumab were published in Annals of the Rheumatic Diseases in February 2022.9 The primary endpoint was the change in a measure of kidney function (baseline 24-hour urine protein creatinine ratio) at week 52 for combined anifrolumab versus placebo groups. Although the trial’s primary endpoint was not met (69% versus 70%, p=0.905), the higher dose tested showed clinically meaningful numeric improvements across multiple secondary and exploratory endpoints versus placebo (with all patients also receiving standard therapy).9 The adverse events that were more common (≥5% difference) in the combined anifrolumab versus placebo groups were herpes zoster, urinary tract infection, and influenza.9 INDICATION AND LIMITATIONS OF USE for SAPHNELO™ (anifrolumab-fnia) SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations. IMPORTANT SAFETY INFORMATION CONTRAINDICATION Known history of anaphylaxis with SAPHNELO. WARNINGS AND PRECAUTIONS Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving immunosuppressive agents, including SAPHNELO. SAPHNELO increases the risk of respiratory infections and herpes zoster. Use caution in patients with severe or chronic infections. Avoid initiating treatment during an active infection and consider interrupting therapy in patients who develop a new infection during treatment Hypersensitivity Reaction Including Anaphylaxis: Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration. Events of angioedema have also been reported. Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis and infusion-related reactions, if they occur. Immediately interrupt administration and initiate appropriate therapy if a serious infusion-related or hypersensitivity reaction (eg, anaphylaxis) occurs Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO on the potential development of malignancies is not known Immunization: Avoid the use of live or live-attenuated vaccines in patients treated with SAPHNELO Use With Biologic Therapies: SAPHNELO is not recommended for use in combination with other biologic therapies, including B-cell targeted therapies ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) are nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster and cough. In the controlled clinical trials, the incidence of infusion-related reactions was 9.4% in patients while on treatment with SAPHNELO and 7.1% in patients on placebo. Infusion-related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness. USE IN SPECIFIC POPULATIONS Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, contact AstraZeneca at 1-877-693-9268. There are insufficient data on the use of SAPHNELO in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Advise female patients to inform their healthcare provider if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving SAPHNELO. Lactation: No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production. Pediatric Use: The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age has not been established. Please see full Prescribing Information, including Patient Information. Notes Lupus nephritis LN is more common in women than in men, and there is a higher prevalence and severity of the disease among African American, Asian and Hispanic women between 15-44, who tend to develop the disease earlier and experience more serious complications.10 IRIS The IRIS Phase III trial is a two-year, multicenter, multinational, randomized, double-blind, placebo-controlled study expected to enroll up to 360 participants aged 18 to 70.11 The aim of the study is to evaluate the efficacy and safety of anifrolumab versus placebo when added to standard therapy (consisting of mycophenolate mofetil and glucocorticoids) in adults diagnosed with active Class III or IV LN (with or without concomitant Class V).11 Active LN will be confirmed by kidney biopsy during screening visits using the 2003 International Society of Nephrology/Renal Pathology Society criteria, and clinically active kidney disease.11 TULIP-LN1 This Phase II double-blinded TULIP-LN1 study randomized 147 patients to receive monthly intravenous anifrolumab basic regimen (300 mg), intensified regimen (900 mg ×3, 300 mg thereafter) or placebo, alongside standard therapy (oral glucocorticoids, mycophenolate mofetil). 12 The primary endpoint was change in baseline 24-hour urine protein–creatinine ratio at week 52 for combined anifrolumab versus placebo groups. The secondary endpoint was complete renal response at week 52.12 Exploratory endpoints included more stringent complete renal response definitions and sustained glucocorticoid reductions (≤7.5 mg/day, weeks 24–52). Safety was analyzed descriptively.12 SAPHNELO SAPHNELO (anifrolumab) is a fully human monoclonal antibody that binds to subunit 1 of the type I IFN receptor, blocking the activity of type I IFN.13 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE.14-19 The majority of adults with moderate to severe SLE have increased type I IFN signaling, which is associated with increased disease activity and severity.14,20 SAPHNELO is approved for the treatment of moderate to severe SLE in the US, Japan, Europe and Canada, with regulatory reviews ongoing in other countries worldwide. This is the first Phase III trial of SAPHNELO in a potential new indication beyond SLE. The IRIS Phase III trial will be conducted in multiple countries involving adult patients with active LN.11 In SLE, SAPHNELO continues to be evaluated in a long-term extension Phase III trial and a Phase III trial assessing subcutaneous delivery.21,22 Additional Phase III trials are planned investigating SAPHNELO in diseases where type I IFN plays a key role, including cutaneous lupus erythematosus and myositis.23 AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and chronic obstructive pulmonary disease (COPD) by focusing on earlier biology-led treatment, eliminating preventable asthma attacks and removing COPD as a top-three leading cause of death. The Company’s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction. With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including SLE), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit and follow us on Twitter @AstraZenecaUS. ©2022 AstraZeneca. All rights reserved. Used with permission. References Lupus Foundation of America. The Expert Series: Kidney health and lupus. Available at: . [Last accessed: May 2022] Medscape. Lupus nephritis. Available at: . [Last accessed: March 2022] Centers for Disease Control and Prevention. Systemic Lupus Erythematosus (SLE). Available at: [Last accessed: March 2022] Almaani S, et al. Update on Lupus Nephritis. Clin J Am Soc Nephrol. 2017; 12 (5): 825-835. 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