Amgen (NASDAQ:AMGN) at the moment introduced the presentation of recent information throughout its uncommon illness portfolio and pipeline on the annual American School of Rheumatology (ACR) Convergence 2024 convention in Washington, D.C. Nov. 14-19, 2024 . New information showcase discount in illness exercise by UPLIZNA® (inebilizumab-cdon) in Immunoglobulin G4-Associated Illness (IgG4-RD) and assist shorter infusion occasions for KRYSTEXXA® (pegloticase) co-administered with weekly oral methotrexate 15 mg.
“These information add to the rising physique of proof for UPLIZNA and KRYSTEXXA and strengthen our dedication to creating new therapy choices for uncommon ailments like IgG4-RD and uncontrolled gout,” mentioned Jay Bradner , M.D., govt vp of Analysis and Growth and chief scientific officer at Amgen. “Sufferers residing with these debilitating circumstances deserve new approaches focusing on the underlying causes of illness, probably enhancing outcomes and enhancing the general therapy expertise.”
Key displays embrace:
A Section 3, Randomized, Double-Blind, Multicenter, Placebo-Managed Examine of Inebilizumab in IgG4-Associated Illness (MITIGATE): Major Efficacy and Security Findings
Summary #0775, Summary Session: Saturday, Nov. 16 from 1:00 p.m. – 1:15 p.m. ET
MITIGATE, the primary randomized, double-blind, placebo-controlled research ever carried out in IgG4-RD, evaluated the protection and efficacy of CD19+ B-cell depletion with UPLIZNA.
Key findings embrace*:
- A clinically significant and statistically vital 87% discount within the danger of IgG4-RD flare in comparison with placebo (Hazard Ratio 0.13, p
- A discount in annualized flare charge for handled and adjudication committee-determined flares throughout the placebo-controlled interval; 0.10 for members receiving UPLIZNA in comparison with 0.71 for members receiving placebo (p
- 57.4% (39 of 68) of members receiving UPLIZNA achieved flare-free, treatment-free, full remission at Week 52 in comparison with 22.4% (15 of 67) members receiving placebo (p
- 58.8% (40 of 68) of members receiving UPLIZNA achieved flare-free, corticosteroid-free, full remission at Week 52 in comparison with 22.4% (15 of 67) members receiving placebo (p
- Affirmation of the distinctive mechanism of motion of UPLIZNA to ship fast and sustained depletion of peripheral B cells resulting in lowered ranges of illness biomarkers. Flares are indicative of excessive illness exercise.
Notably, 89.7% (61 of 68) of UPLIZNA-treated sufferers required no glucocorticoid therapy for illness management throughout the placebo-controlled interval, in comparison with 37.3% (25 of 67) of sufferers on placebo. After Week 8, UPLIZNA-treated sufferers skilled a ten-fold discount in whole glucocorticoid use relative to placebo.
The security leads to the placebo-controlled interval have been in keeping with the established security profile of UPLIZNA. The most typical treatment-emergent opposed occasions included COVID-19, lymphopenia, urinary tract an infection, and headache.
The information have been concurrently printed within the New England Journal of Drugs . In August, the U.S. Meals and Drug Administration granted Breakthrough Remedy Designation for UPLIZNA in IgG4-RD primarily based on information from the MITIGATE research, and regulatory submitting actions are presently underway.
*All p-values observe the New England Journal of Drugs reporting tips; values smaller than 0.001 are offered as 0.001.
Security, Tolerability and Efficacy of Pegloticase Administered with a Shorter Infusion Length in Topics with Uncontrolled Gout Receiving Methotrexate: Major Findings of the AGILE Open-label Trial
Summary #2012, Poster Session C: Monday, Nov. 18 from 10:30 p.m. – 12:30 p.m. ET
The AGILE trial assessed the protection, tolerability and efficacy of KRYSTEXXA administered with a shorter infusion period in sufferers with uncontrolled gout receiving methotrexate as co-administration.
Security and efficacy information from the 60-minute infusion period cohort of the AGILE trial are just like the MIRROR randomized medical trial and present administration of KRYSTEXXA with methotrexate over not less than 120 minutes.
Key findings embrace:
- 67.2% (78 of 116) of members receiving a 60-minute infusion period of KRYSTEXXA with methotrexate achieved and maintained a response throughout Month 6, outlined as a urate stage of
- 6.0% (7 of 116) of members receiving a 60-minute infusion period of KRYSTEXXA with methotrexate skilled an infusion response, together with anaphylaxis (1.7%; 2 of 116 members), primarily based on adjudicated outcomes.
Regulatory filings for the AGILE research findings are presently underway.
About Uncontrolled Gout
Gout is a continual, progressive inflammatory type of arthritis that’s brought on by excessive urate ranges within the physique. Tiny needle-like crystals can kind and construct up nearly anyplace within the physique. Sufferers with uncontrolled gout proceed to have excessive ranges of uric acid and ongoing signs of gout regardless of the usage of oral urate-lowering therapies. Uncontrolled gout is a continual, systemic illness, and if not addressed can have vital medical penalties.
About KRYSTEXXA ® (pegloticase)
KRYSTEXXA is the primary and solely biologic authorized by the FDA to deal with adults residing with uncontrolled gout, a painful and debilitating inflammatory situation with which individuals proceed to have abnormally excessive ranges of uric acid and signs regardless of the usage of typical therapies.
In 2022, the FDA authorized increasing labeling to incorporate co-administration with the immunomodulator methotrexate, primarily based on outcomes from the MIRROR randomized managed trial, which confirmed vital enhancements in efficacy and security, together with a discount in infusion reactions.
KRYSTEXXA ® (pegloticase) U.S. Indication
KRYSTEXXA is indicated for the therapy of continual gout in grownup sufferers who’ve did not normalize serum uric acid and whose indicators and signs are inadequately managed with xanthine oxidase inhibitors on the most medically acceptable dose or for whom these medicine are contraindicated.
Limitations of Use: KRYSTEXXA is just not advisable for the therapy of asymptomatic hyperuricemia.
KRYSTEXXA U.S. Essential Security Info
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA
- Anaphylaxis and infusion reactions have been reported to happen throughout and after administration of KRYSTEXXA.
- Anaphylaxis might happen with any infusion, together with a primary infusion and usually manifests inside 2 hours of the infusion. Delayed hypersensitivity reactions have additionally been reported.
- KRYSTEXXA must be administered in healthcare settings and by healthcare suppliers ready to handle anaphylaxis and infusion reactions.
- Premedicate with antihistamines and corticosteroids and carefully monitor for anaphylaxis for an acceptable interval after administration of KRYSTEXXA.
- Monitor serum uric acid ranges prior to every infusion and discontinue therapy if ranges enhance to above 6 mg/dL, notably when 2 consecutive ranges above 6 mg/dL are noticed.
- Display screen sufferers in danger for glucose-6-phosphate dehydrogenase (G6PD) deficiency previous to beginning KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in sufferers with G6PD deficiency. KRYSTEXXA is contraindicated in sufferers with G6PD deficiency.
CONTRAINDICATIONS
- In sufferers with G6PD deficiency.
- In sufferers with historical past of significant hypersensitivity reactions, together with anaphylaxis, to KRYSTEXXA or any of its elements.
WARNINGS AND PRECAUTIONS
Gout Flares: A rise in gout flares is ceaselessly noticed upon initiation of anti-hyperuricemic remedy, together with KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is advisable beginning not less than 1 week earlier than initiation of KRYSTEXXA remedy and lasting not less than 6 months, until medically contraindicated or not tolerated.
Congestive Coronary heart Failure: KRYSTEXXA has not been formally studied in sufferers with congestive coronary heart failure, however some sufferers within the pre-marketing placebo-controlled medical trials skilled exacerbation. Train warning in sufferers who’ve congestive coronary heart failure and monitor sufferers carefully following infusion.
ADVERSE REACTIONS
Essentially the most generally reported opposed reactions (≥5%) are:
- KRYSTEXXA co-administration with methotrexate: gout flares, arthralgia, COVID-19, nausea and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reactions, ache in extremity, hypertension and vomiting.
- KRYSTEXXA pre-marketing placebo-controlled trials: gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest ache, anaphylaxis and vomiting.
Please see Full Prescribing Info, together with Boxed Warning.
About Immunoglobulin G4-related illness (IgG4-RD)
Immunoglobulin G4-related illness (IgG4-RD) is a continual, systemic, immune-mediated, fibroinflammatory illness which might have an effect on quite a few and usually a number of organs of the physique. It’s a progressive illness affecting new organs over time both consecutively or concurrently and is characterised by durations of remission and unpredictable illness flares. IgG4-RD may cause irreversible organ harm with or with out the presence of signs. Consciousness of how organ harm manifests is critically necessary to tell the well timed analysis of IgG4-RD. B cells are central to the pathogenesis of IgG4-RD. In IgG4-RD, CD19-expressing (CD19+) B cells are thought to drive inflammatory and fibrotic processes and work together with different immune cells that contribute to illness exercise.
The incidence is estimated at 1-5 in 100,000 though the variety of IgG4-RD sufferers is troublesome to find out primarily based on restricted epidemiology information. The standard age of onset of IgG4-RD is between 50 and 70 years outdated and, in contrast to many different immune-mediated ailments, IgG4-RD is extra more likely to happen in males than ladies.
About UPLIZNA ® (inebilizumab-cdon)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes focused and sustained depletion of key cells that contribute to underlying illness course of (autoantibody-producing CD19+ B cells, together with plasmablasts and a few plasma cells). After two preliminary infusions, sufferers want one dose of UPLIZNA each six months.
UPLIZNA is presently authorized for the therapy of neuromyelitis optica spectrum dysfunction (NMOSD) in grownup sufferers who’re anti-aquaporin-4 (AQP4) antibody constructive in the US and different nations around the globe.
UPLIZNA ® (inebilizumab-cdon) U.S. INDICATION
UPLIZNA is indicated for the therapy of neuromyelitis optica spectrum dysfunction (NMOSD) in grownup sufferers who’re anti-aquaporin-4 (AQP4) antibody constructive.
IMPORTANT SAFETY INFORMATION
UPLIZNA is contraindicated in sufferers with:
- A historical past of life-threatening infusion response to UPLIZNA
- Lively hepatitis B an infection
- Lively or untreated latent tuberculosis
WARNINGS AND PRECAUTIONS
Infusion Reactions: UPLIZNA may cause infusion reactions, which might embrace headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or different signs. Infusion reactions have been commonest with the primary infusion however have been additionally noticed throughout subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.
Infections: The most typical infections reported by UPLIZNA-treated sufferers within the randomized and open-label durations included urinary tract an infection (20%), nasopharyngitis (13%), higher respiratory tract an infection (8%), and influenza (7%). Delay UPLIZNA administration in sufferers with an lively an infection till the an infection is resolved.
Elevated immunosuppressive results are attainable if combining UPLIZNA with one other immunosuppressive remedy.
The danger of Hepatitis B Virus (HBV) reactivation has been noticed with different B-cell-depleting antibodies. Carry out HBV screening in all sufferers earlier than initiation of therapy with UPLIZNA. Don’t administer to sufferers with lively hepatitis.
Though no confirmed instances of Progressive Multifocal Leukoencephalopathy (PML) have been recognized in UPLIZNA medical trials, JC virus an infection leading to PML has been noticed in sufferers handled with different B-cell-depleting antibodies and different therapies that have an effect on immune competence. On the first signal or symptom suggestive of PML, withhold UPLIZNA and carry out an acceptable diagnostic analysis.
Sufferers must be evaluated for tuberculosis danger elements and examined for latent an infection previous to initiating UPLIZNA.
Vaccination with live-attenuated or stay vaccines is just not advisable throughout therapy and after discontinuation, till B-cell repletion.
Discount in Immunoglobulins: There could also be a progressive and extended hypogammaglobulinemia or decline within the ranges of whole and particular person immunoglobulins comparable to immunoglobulins G and M (IgG and IgM) with continued UPLIZNA therapy. Monitor the extent of immunoglobulins in the beginning, throughout, and after discontinuation of therapy with UPLIZNA till B-cell repletion particularly in sufferers with opportunistic or recurrent infections.
Fetal Danger: Could trigger fetal hurt primarily based on animal information. Advise females of reproductive potential of the potential danger to a fetus and to make use of an efficient technique of contraception throughout therapy and for six months after stopping UPLIZNA.
Antagonistic Reactions: The most typical opposed reactions (not less than 10% of sufferers handled with UPLIZNA and larger than placebo) have been urinary tract an infection and arthralgia.
For extra data on UPLIZNA, please see the Full Prescribing Info at www.UPLIZNA.com .
About Amgen
Amgen discovers, develops, manufactures, and delivers revolutionary medicines to assist hundreds of thousands of sufferers of their struggle towards a few of the world’s hardest ailments. Greater than 40 years in the past, Amgen helped to determine the biotechnology trade and stays on the cutting-edge of innovation, utilizing expertise and human genetic information to push past what’s recognized at the moment. Amgen is advancing a broad and deep pipeline that builds on its present portfolio of medicines to deal with most cancers, coronary heart illness, osteoporosis, inflammatory ailments and uncommon ailments.
In 2024, Amgen was named one of many “World’s Most Modern Firms” by Quick Firm and one in every of “America’s Finest Giant Employers” by Forbes, amongst different exterior recognitions . Amgen is among the 30 corporations that comprise the Dow Jones Industrial Common ® , and it’s also a part of the Nasdaq-100 Index ® , which incorporates the biggest and most revolutionary non-financial corporations listed on the Nasdaq Inventory Market primarily based on market capitalization.
For extra data, go to Amgen.com and observe Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .
Ahead-Wanting Statements
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