• News
  • Technology
  • Culture
  • Entertainment
  • Sport
  • Travel
  • Music
  • More
    • Politics
    • Lifestyle
    • TV
    • Games
Sunday, April 2, 2023
  • Login
No Result
View All Result
NEWSLETTER
FINCHANNEL
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • America
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • CityLife
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • America
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • CityLife
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE
No Result
View All Result
FINCHANNEL
No Result
View All Result
Home Health&Beauty

Lilly and Incyte highlight positive data for Olumiant in rheumatoid arthritis

by The FINANCIAL
November 3, 2020
in Health&Beauty
0
Share on FacebookShare on Twitter

The FINANCIAL — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today positive data for Olumiant® (baricitinib) will be presented at ACR Convergence 2020, the American College of Rheumatology’s virtual annual meeting taking place November 5-9, 2020. The Olumiant data being presented at this year’s meeting include new long-term studies in adult patients living with rheumatoid arthritis (RA), along with real-world evidence (RWE) on safety and efficacy.

ADVERTISEMENT

At this year’s meeting, results from a post-hoc analysis evaluating the long-term efficacy of Olumiant for patients with active RA who were inadequate responders (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic DMARDs (bDMARD) (Abstract #0224) will be shared. In this analysis, 27.5% of the csDMARD-IR and 18.4% of the bDMARD-IR patients had Low Disease Activity defined by Simple Disease Activity Index (LDA; SDAI ≤11) after 2.3 years (at week 120) in a Non-responder Imputation analysis. For those patients who remained in the study, 85% and 86% of csDMARD-IR and bDMARD-IR respectively, maintained low disease activity at 2.3 years. No new safety concerns were identified.

“In this analysis of the long-term studies of Olumiant in adults with RA, the medicine demonstrated efficacy over more than two years as measured by the proportion of patients who achieved low disease activity,” said Alvin Wells, M.D., Ph.D., director of the Aurora Rheumatology and Immunotherapy Center. “The safety and efficacy from this study helps support Olumiant 2-mg once daily as a long-term treatment for patients with moderate to severe RA.”

RelatedPosts

Canine brain wiring influenced by human-driven breeding practices

NIH researchers discover new autoinflammatory disease, suggest target for potential treatments

SARS-CoV-2 infection weakens immune-cell response to vaccination

107,735 Americans died between August 2021 and August 2022 from drug poisonings

Lilly will also highlight data from a long-term extension study that evaluated radiographic progression of structural joint damage in adult patients with active RA over 5 years of treatment with Olumiant (Abstract # 1235). The study enrolled patients who had completed treatment in one of three Phase 3 trials, including patients who were DMARD-naïve, csDMARD-IR and methotrexate (MTX)-IR, and assessed baricitinib 4-mg once daily as monotherapy or in combination with MTX or other csDMARDs and baricitinib 2-mg once daily in combination with other csDMARD. The data suggest that the different RA patient populations treated with baricitinib for up to 5 years can maintain low rates of radiographic progression, as assessed by the van der Heijde modified Total Sharp Score (mTSS).

“We are pleased with the data being presented at this year’s virtual ACR meeting highlighting the depth of Lilly‘s immunology portfolio and the potential impact our medicines may have for patients,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “Furthermore, the data being showcased at this meeting demonstrate our commitment to ongoing evaluation of the long-term safety and efficacy of Olumiant in patients living with RA.”

Additionally, Lilly will showcase RWE from a postmarketing safety surveillance study (Abstract # 0203). Results include 24-week safety data from 1,992 patients consecutively prescribed Olumiant in Japan. No new safety signals were observed during the initial analysis, and the study will continue to collect serious adverse events for three years.

An integrated safety analysis of pooled data from nine clinical trials of Olumiant is also being presented (Abstract # 0202). Across the trials, 3,770 patients with RA received Olumiant for a total of 13,148 patient-years of exposure with a median time on treatment of 4.2 years and up to a maximum of 8.4 years. The data reinforce the safety profile of Olumiant in the treatment of RA, with no new safety concerns reported in the analysis.

Olumiant, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
  • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

WARNINGS AND PRECAUTIONS

SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

  • with chronic or recurrent infection
  • who have been exposed to TB
  • with a history of a serious or an opportunistic infection
  • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
  • with underlying conditions that may predispose them to infection.

Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

Tuberculosis – Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS: Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES:

Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

VACCINATIONS: Avoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

ADVERSE REACTIONS
Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

USE IN SPECIFIC POPULATIONS

PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

Tags: ACR Convergence 2020American College of Rheumatologyantirheumatic drugsbiologic DMARDscsDMARDINCYIncytelillyllyOLUMIANTrheumatoid arthritis
ADVERTISEMENT
The FINANCIAL

The FINANCIAL

Related Posts

Health&Beauty

Canine brain wiring influenced by human-driven breeding practices

by The FINANCIAL
March 31, 2023
0

National Institutes of Health researchers have shown that areas of the genome related to brain development harbor variants that may...

Read more

NIH researchers discover new autoinflammatory disease, suggest target for potential treatments

March 28, 2023
New Study of Coronavirus Variants Predicts Virus Evolving to Escape Current Vaccines, Treatments

SARS-CoV-2 infection weakens immune-cell response to vaccination

March 20, 2023
107,735 Americans died between August 2021 and August 2022 from drug poisonings

107,735 Americans died between August 2021 and August 2022 from drug poisonings

March 20, 2023
Next Post
Deutsche Bank Luxembourg announced management changes

Deutsche Bank Luxembourg announced management changes

Please login to join discussion
ADVERTISEMENT
  • Trending
  • Comments
  • Latest
How to Check KRA Pin Using ID Number

How to Check KRA Pin Using ID Number

June 25, 2018
EasyJet to fly to London from Stockholm Arlanda

The London Diplomatic List, Addresses, Contacts & Working Hours

January 23, 2023
How to Manage an Employee Who’s Having a Personal Crisis

5 Assets To Store Your Wealth During Times Of Crisis

September 22, 2022
Russian issue: State Sponsors of Terrorism, U.S. State Department

Americans’ Favorable Rating of Russia Sinks to New Low of 9%

March 14, 2023
Kvaratskhelia Football Dynasty: Mamia, Badri, Khvicha and Tornike

Kvaratskhelia Football Dynasty: Mamia, Badri, Khvicha and Tornike

August 11, 2022
Reborn of Georgian Skeet

Reborn of Georgian Skeet

April 1, 2023

IMF Executive Board Approves US$15.6 Billion for Ukraine as part of a US$115 Billion Overall Support Package

April 1, 2023

Canine brain wiring influenced by human-driven breeding practices

March 31, 2023
5 Gambling Trends Transforming the Gambling Industry in 2021

William Hill Group businesses to pay record £19.2m for failures

March 31, 2023
Protected: Lear Capital Looks at What Effect the Great Resignation May Have on the Economy

Protected: Lear Capital Looks at What Effect the Great Resignation May Have on the Economy

March 30, 2023

Popular Last 24h

  • IMF Executive Board Approves US$15.6 Billion for Ukraine as part of a US$115 Billion Overall Support Package

    0 shares
    Share 0 Tweet 0
  • How to Check KRA Pin Using ID Number

    0 shares
    Share 0 Tweet 0
  • 5 Assets To Store Your Wealth During Times Of Crisis

    0 shares
    Share 0 Tweet 0
  • Fintech and cleantech win as global venture capital investments become more focused

    0 shares
    Share 0 Tweet 0
  • How to unlock your full investment potential

    0 shares
    Share 0 Tweet 0
  • Pushing the Boundaries – an Exhibition in Space

    0 shares
    Share 0 Tweet 0
  • Tegeta Motors was officially awarded with the International Award of Groupauto International

    0 shares
    Share 0 Tweet 0

LATEST POSTS

Reborn of Georgian Skeet

Reborn of Georgian Skeet

April 1, 2023

IMF Executive Board Approves US$15.6 Billion for Ukraine as part of a US$115 Billion Overall Support Package

April 1, 2023

Canine brain wiring influenced by human-driven breeding practices

March 31, 2023
5 Gambling Trends Transforming the Gambling Industry in 2021

William Hill Group businesses to pay record £19.2m for failures

March 31, 2023
Protected: Lear Capital Looks at What Effect the Great Resignation May Have on the Economy

Protected: Lear Capital Looks at What Effect the Great Resignation May Have on the Economy

March 30, 2023

 INSEAD unveils a 10-year campus re-imagination masterplan

March 30, 2023
Surgeon General spotlights opioid abuse, AOA offers doctors’ reference guide

telehealth services and medications for opioid use disorder associated with reduced risk for fatal overdose

March 30, 2023
Protected: iFLY: Delivering the Dream of Flight to Everyone

Protected: iFLY: Delivering the Dream of Flight to Everyone

March 30, 2023

Iceland is the most in-demand destination for a solo female travel trip

March 28, 2023
Inaugural Address by President Joseph R. Biden, Jr.

Biden Overall Approval at 40%, Key Issue Ratings Lackluster

March 28, 2023

LATEST INTERVIEWS

‘Russia cannot be treated as a reasonable and reliable trade partner

‘Russia cannot be treated as a reasonable and reliable trade partner

by The FINANCIAL
February 13, 2023
0

We should increase our joint efforts to assist the growing tech sector here in Georgia

We should increase our joint efforts to assist the growing tech sector here in Georgia

by The FINANCIAL
February 13, 2023
0

‘Georgia has much to offer to UK investors

‘Georgia has much to offer to UK investors

by The FINANCIAL
February 13, 2023
0

‘The best way for the Georgian economy to prosper is to join the EU

‘The best way for the Georgian economy to prosper is to join the EU

by The FINANCIAL
February 13, 2023
0

‘The Kremlin wants Georgia to fail or abandon its European path

‘The Kremlin wants Georgia to fail or abandon its European path

by The FINANCIAL
February 13, 2023
0

Russian Patriarch Kirill Says Dying In Ukraine ‘Washes Away All Sins’

Interview: Why Putin Might Prefer A Stalemate To Going Nuclear On Ukraine

by The FINANCIAL
October 22, 2022
0

Kvaratskhelia Football Dynasty: Mamia, Badri, Khvicha and Tornike

Kvaratskhelia Football Dynasty: Mamia, Badri, Khvicha and Tornike

by Tengiz Pachkoria
August 11, 2022
0

“Green business is a key instrument to support business development in a sustainable way”

“Green business is a key instrument to support business development in a sustainable way”

by The FINANCIAL
July 27, 2022
0

Newsletter

ADVERTISEMENT

GET IN TOUCH

E-mail your company news at:

news (at) financial.ge Letters to the Editor: editor (at) finchannel.com

Local Marketing contact:

(+99532) 2252 275 | 76 EXT: 1 (+995 558) 03 03 03 (mobile) marketing (at) finchannel.com

Requests from abroad:

(+99532) 2252 275 | 76 EXT: 7 (+995599) 96 52 52 Email: zviadi (@) finchannel.com Contact video editor: E-mail: video (at) financial.ge

Postal address: 17 Mtskheta str. Tbilisi, Georgia 0179 The FINANCIAL

RESOURCE

  • Work at the FINANCIAL
  • ePaper
  • Advertise in The FINANCIAL
  • Access ePaper
  • Guest posts
  • Contributed articles
  • AmericanStockNews
  • Coupon Codes
  • GLOSSY MAG
American Culture Center
ACC Partner

GUIDEBOOK

  • Meet our team
  • Invest in Georgia
  • Become contributor
  • Archive

FOLLOW US

  • Facebook
  • Twitter
  • Google+
  • Youtube
No Result
View All Result
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • America
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • CityLife
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE

© 2023 JNews - Premium WordPress news & magazine theme by Jegtheme.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
This website uses cookies. By continuing to use this website you are giving consent to cookies being used. Visit our Privacy and Cookie Policy.