RegulationPriority Review (US), Fast Track (US), Emergency Use Authorization (US), Special Review Project (CN), Breakthrough Therapy (US), Orphan Drug (US)

Structure

Molecular FormulaC16H17N7O2S

InChIKeyXUZMWHLSFXCVMG-UHFFFAOYSA-N

CAS Registry1187594-09-7

231

Clinical Trials associated with Baricitinib

NCT06381661 / Not yet recruitingPhase 3IIT

PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

Start Date01 Apr 2026

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

NCT06687551 / Not yet recruitingPhase 4IIT

JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients

This study aims to assess the feasibility of tapering JAK inhibitors in rheumatoid arthritis patients in low disease activity by comparing a group of patients tapering the JAK inhibitor dosage to a group of patients continuing the full-dose.
Participants will:
* Either take
1. JAK inhibitor dose-tapering strategy.
2. JAK inhibitor continuous therapy strategy.
* Visit the clinic once every 3 months for checkups and tests
* Keep a diary of their treatment intake and symptoms

Start Date01 Jan 2025

Sponsor / Collaborator

Toulouse University Hospital

IRCT20240920063104N1 / SuspendedNot ApplicableIIT

A comparative clinical trial study of the therapeutic effects and side effects of the two drugs Baricitinib and Tofacitinib in pediatric patients with Alopecia Areata

Start Date21 Dec 2024

Sponsor / Collaborator

Tehran University of Medical Sciences

100 Clinical Results associated with Baricitinib

100 Translational Medicine associated with Baricitinib

100 Patents (Medical) associated with Baricitinib

1,446

Literatures (Medical) associated with Baricitinib

01 Jan 2025·LUPUS

A rare case of late-onset spondyloenchondrodysplasia with immune dysregulation presenting as adult-onset monogenic lupus

Article

Author: Ayvaz, Bilal Berke ; Ugurlu, Serdal ; Firat Senturk, Esra ; Firtina, Sinem

Background:

Spondyloenchondrodysplasia is classified as an interferonopathy resulting from recessive mutations in the ACP5 gene and manifests with various clinical features, including distinctive skeletal dysplasia, neurological abnormalities, immune dysfunction resembling systemic lupus erythematosus (SLE) and Sjogren’s syndrome. While SLE is typically considered multifactorial and more prevalent in adulthood, a subset of approximately 10%–25% of childhood cases arise from monogenic form. Among these, spondyloenchondrodysplasia accounts for only a rare fraction of monogenic lupus cases, with only 22 reported instances in the literature.

Case Report:

This paper presents a new case of spondyloenchondrodysplasia-immune dysregulation (SPENCDI) in an adult patient born to nonconsanguineous parents. The patient was diagnosed with SPENCDI and exhibited immune neutropenia, anti-dsDNA positivity, platyspondyly, immune deficiency, and a homozygous variant (c.155 A > C, p. Lys52Thr) in the ACP5 gene, previously classified as pathogenic. Notably, the patient achieved successful clinical management through the initiation of baricitinib treatment, a Janus kinase inhibitor.

Conclusion:

SPENCDI represents an uncommon cause of SLE in adulthood. Clinicians should be vigilant of underlying Mendelian inheritance when encountering patients with associated features. While treatments for both Mendelian and non-Mendelian SLE are similar, Janus kinase inhibitors like baricitinib show potential for managing interferon-signature monogenic SLE cases.

01 Jan 2025·Ophthalmology science

Systemic Treatment with the Janus Kinase Inhibitor Baricitinib in Ocular Chronic Graft-versus-Host Disease

Article

Author: Payne, Debbie ; Figg, William Douglas ; Vitale, Susan ; Im, Annie P ; Cousineau-Krieger, Chantal ; Magone, M Teresa ; Newgen, Janine ; Igbinosun, Celestina ; FitzGibbon, Edmond J ; Pavletic, Steven ; Holtzman, Noa G ; Cowen, Edward W ; McManus, Taylor ; Peer, Cody ; Mays, Jacqueline W ; Zhao, Aaron

Objective:

To investigate the effects of oral baricitinib on ocular surface disease (OSD) in patients with chronic graft-versus-host disease (cGVHD).

Design:

Prospective phase 1 to 2 single institution trial.

Subjects:

Eighteen patients with ocular graft-versus-host-disease (oGVHD) and systemic steroid-refractory cGVHD.

Methods:

Oral baricitinib (2 mg and 4 mg) was administered daily for up to 12 months in an intrapatient dose-escalation design. National Institutes of Health (NIH) oGVHD score, vision, corneal Oxford staining (COS), tear break-up time (TBUT), Schirmer I test (ST) without anesthesia, and microliter tear equivalent conversion were assessed at baseline, 6 months (primary efficacy end point), and 12 months if patients remained on the drug.

Main Outcome Measures:

Improvement in NIH oGVHD score, COS, TBUT, and ST results in patients with and without conjunctival fibrosis at 6 months.

Results:

At 6 months, the NIH oGVHD score significantly improved (P = 0.014) with all OSD parameters also showing improvement, though not statistically significant. COS baseline, 2.17 to 0.95; TBUT baseline, 6.66 to 8.18 seconds, Schirmer I baseline, 3.86 mm (2.6 μl) to 5.56 mm (3.9 μl). For patients continuing treatment at 12 months improvements persisted compared with the baseline but remained statistically nonsignificant. Corneal Oxford staining decreased to 0.94; TBUT increased to 8.95 seconds, and ST improved to 10.19 mm (7.2 μL). Conjunctival fibrosis was present in 39% (n = 7) of the patients at baseline. The greatest improvement was observed in the 11 patients without prior conjunctival fibrosis compared with the baseline: COS 1.84, TBUT 6.32 seconds, ST 4.07 mm (2.1 μl); 6 months: COS 0.25 (P = 0.018), TBUT 8.62 seconds, ST 9.12 mm (5.4 μl); 12 months: COS 0, TBUT 10.29 seconds, ST 16.88 mm (10.6 μl). Vision was stable in all groups. Two patients developed asymptomatic, self-limited conjunctival papillomas, and 1 patient developed uncomplicated bacterial conjunctivitis twice. No dose limiting toxicity was observed. Severe adverse events with hospitalizations for possible drug-related systemic infections occurred in 5 patients.

Conclusions:

Systemic baricitinib was well-tolerated, improved NIH oGVHD scores and OSD parameters in patients with oGVHD, with the greatest benefits observed in patients without pre-existing conjunctival fibrosis. Conjunctival fibrosis may affect outcomes and should be considered in patient selection for clinical trials.

Financial Disclosures:

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

01 Jan 2025·BIOORGANIC CHEMISTRY

A Glimpse for the subsistence from pandemic SARS-CoV-2 infection

Review

Author: Sarkar, Nandan ; Rath, Santosh K ; Panchpuri, Mitali ; Dash, Ashutosh K

COVID-19 is an emerging viral pandemic caused by SARS-CoV-2, which is the causative agent of unprecedented disease-causing public health threats globally. Worldwide, this outbreak is wreaking havoc due to failure in risk assessment regarding the urgency of the pandemic. As per the reports, many secondary complications which include neurological, nephrological, gastrointestinal, cardiovascular, immune, and hepatic abnormalities, are linked with COVID -19 infection which is associated with prominent respiratory disorders including pneumonia. Hindering the initial binding of the virus with Angiotensin-converting enzyme 2 (ACE2) through the spike protein is one potential boulevard of monoclonal antibodies. Although some drug regimens and vaccines have shown safety in trials, none have been entirely successful yet. This review highlights, some of the potential antibodies (tocilizumab, Sarilumab, Avdoralimab, Lenzilumab, Interferon (alfa /beta /gamma)) screened against SARS-CoV-2 and the most promising drugs (Favipiravir, Hydroxychloroquine, Niclosamide, Ribavirin, Baricitinib, Remdesivir, Arbidol Losartan, Ritonavir, Lopinavir, Baloxavir, Nitazoxanide, Camostat) in various stages of development with their synthetic protocol and their clinical projects are discussed to counter COVID -19.

475

News (Medical) associated with Baricitinib

23 Dec 2024

·www.businesswire.com

Bristol Myers Squibb Announces Positive Topline Results from Two Pivotal Phase 3 Trials Evaluating Sotyktu (deucravacitinib) in Adults with Psoriatic Arthritis

PRINCETON, N.J.--( BUSINESS WIRE )-- Bristol Myers Squibb (NYSE: BMY) today announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase 3 trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu -treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo. Additionally, the POETYK PsA-1 and POETYK PsA-2 trials met important secondary endpoints across PsA disease activity at Week 16. The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with the established safety profile of Sotyktu observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials. "Psoriatic arthritis is a heterogenous disease that causes a range of different symptoms, including joint pain and swelling, as well as psoriatic skin lesions. Despite available therapies, rheumatologists continue to express a need for a safe and effective oral treatment," said Roland Chen , MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. "These POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu . We are encouraged by the positive data across both Phase 3 trials and look forward to discussing the results with health authorities." Bristol Myers Squibb will work with key investigators to present detailed results at upcoming medical congresses. These topline results represent the first Phase 3 clinical trials for Sotyktu in a rheumatic condition. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis. Bristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in these clinical trials. About the Sotyktu Phase 3 Psoriatic Arthritis Trial Program The Phase 3 Sotyktu psoriatic arthritis (PsA) program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202 ) and POETYK PsA-2 (IM011-055; NCT04908189 ). POETYK PsA-1 enrolled approximately 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 enrolled approximately 730 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm. The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Important secondary endpoints were also assessed at Week 16 across measures of PsA disease activity. Patients in both trials completing 52 weeks of treatment are potentially eligible to enroll in the open-label extension study. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis will develop PsA. In addition to the loss of physical function, pain and fatigue caused by PsA, the disease can significantly impact the mental and emotional well-being of patients. Patients with PsA are also at increased risk of serious comorbidities, including cardiovascular disease, metabolic syndrome, depression and anxiety. About Sotyktu (deucravacitinib) Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis. Bristol Myers Squibb: Pursuing Bold Science in Immunology to Transform Patients’ Lives Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can make simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science as we work to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Our sequential immunotherapy research framework aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy. By continuously pushing the boundaries of scientific knowledge, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures. Our collaborations with patients, caregivers, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most – the promise of living a better life. SOTYKTU U.S. INDICATION SOTYKTU ® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU. WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU. Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an opportunistic infection with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated. Viral Reactivation Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C. Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment. Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU. Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded. Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated. Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA. ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne. SPECIFIC POPULATIONS Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072. Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition. Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment. SOTYKTU is available in 6 mg tablets. Please see U.S. Full Prescribing Information , including Medication Guide , for SOTYKTU. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , X , YouTube , Facebook and Instagram . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that Sotyktu (deucravacitinib) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Sotyktu for such additional indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

Clinical ResultPhase 3Drug ApprovalImmunotherapyPhase 2

23 Dec 2024

·medcitynews.com

Bristol Myers Squibb’s Sotyktu Meets Goals in Two Pivotal Psoriatic Arthritis Studies - MedCity News

A Bristol Myers Squibb drug that was first in its class to hit a certain immunological target now has positive data from two pivotal tests in psoriatic arthritis that could support expanding use of the product to this inflammatory autoimmune condition. Expanding approval of the drug, Sotkytu, to include psoriatic arthritis would grow revenue for a product that so far has fallen short of the blockbuster expectations that followed its 2022 approval in plaque psoriasis. Meanwhile, competition is heating up as competitors make headway with their own drug candidates for the target, an enzyme called TYK2. Psoriatic arthritis is an autoimmune disease that leads to painful swelling in joints and ligaments as well as skin lesions. First-line treatment includes disease-modifying antirheumatic drugs, both small molecules and biologics. For those whose disease does not respond to these therapies, a class of drugs called Janus kinase (JAK) inhibitors offer another treatment option. BMS’ Sotyktu could bring patients another option, and a potentially earlier one that also has a better safety profile. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions BMS said Monday that its TYK2 inhibitor met the main goal of two Phase 3 tests in active psoriatic arthritis, one that enrolled patients who were not previously treated with a disease-modifying antirheumatic drug and the other with patients who previously received TNF-alpha inhibitors, drugs from an older class of biologic medicines whose approved uses include treating psoriatic arthritis. Without releasing specific figures for the pair of 16-week studies, BMS said a significantly greater proportion of those treated with its drug achieved a 20% improvement or greater according to a composite measure of the signs and symptoms of the chronic autoimmune disorder. Also, the once daily pill met a key secondary goal measuring disease activity at week 16. TYK2, which is closely related to JAK proteins, is involved in signaling pathways associated with inflammation. Hitting TYK2 while avoiding JAKs is intended to be safer. The risks of hitting JAK proteins include cardiovascular and cancer complications. These risks are now flagged in a black box warning for the entire JAK inhibitor drug class. The FDA approved JAK-blocking drugs for psoriatic arthritis are Pfizer’s Xeljanz and AbbVie’s Rinvoq. JAK inhibitors were not used as a comparator in BMS’s placebo-controlled psoriatic arthritis tests, named POETYK PsA-1 and POETYK PsA-2. On measures of safety, BMS said the latest results are consistent with Sotyktu’s established safety profile from earlier clinical trials. In the pivotal study that led to the drug’s approval as a treatment for moderate-to-severe plaque psoriasis, the most common adverse event was upper respiratory tract infection. The company said it will work with clinical trial investigators to present detailed study results at upcoming medical conferences. Health IT Reducing Clinical and Staff Burnout with AI Automation As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers. By Dr. Michael Blackman, Chief Medical Officer at Greenway Health “These POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu,” Roland Chen, BMS’s senior vice president and head, immunology, cardiovascular and neuroscience development, said in a prepared statement. “We are encouraged by the positive data across both Phase 3 trials and look forward to discussing the results with health authorities.” With the latest data in psoriatic arthritis, BMS is trying to fend off competition. Takeda Pharmaceutical’s zasocitinib (formerly known as TAK-279), acquired in a $4 billion deal, has reached Phase 3 testing in psoriasis and mid-stage clinical development in psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Startup Sudo Biosciences, which emerged from stealth in 2022, is developing TYK2 inhibitors for neuroinflammatory disorders. BMS reported Sotyktu accounted for $163 million in revenue for the first nine months of 2024, a 52.3% increase compared to the same period in 2023. In addition to the psoriatic arthritis research, the drug has reached late-stage clinical development in Sjogren’s syndrome and systemic lupus erythematosus.

Phase 3AcquisitionDrug ApprovalClinical Result

20 Dec 2024

·www.drugs.com

A New Way to Treat Sjögren’s Disease? Researchers Are Hopeful

FRIDAY, Dec. 20, 2024 -- An existing drug might be able to treat an autoimmune disorder that causes dry eye, dry mouth, fatigue and muscle or joint pain. Baricitinib ( Olumiant ), a drug currently used to treat rheumatoid arthritis, appears to effectively curb the symptoms of Sjögren’s disease, according to results from lab mice published in a new study. The drug does this by suppressing the malfunctioning immune signals that drive Sjögren’s, researchers report in the journal Science Translational Medicine . “Not only did we dissect the underlying cause for Sjögren’s disease in our mouse model, but we correlated these findings to the disease’s classification criteria and genetic signatures in humans,” senior researcher Dr. Stefan Feske , a professor of pathology at NYU Grossman School of Medicine, said in a university news release. “Moreover, I think using baricitinib has great promise in the treatment of Sjögren’s disease going forward,” Feske added. Sjögren’s disease occurs when the immune system attacks the glands that produce saliva and tears, resulting in dry mouth and eyes, researchers said. Patients can also experience fatigue, joint and muscle pain , rashes and lung inflammation. It’s the second most common rheumatic autoimmune disease in the United States, three times more common than related diseases like lupus and multiple sclerosis, according to the Sjögren’s Foundation. As many as 4 million Americans -- 1 in every 70 people -- are affected by Sjögren’s, the foundation says. “Not being able to produce tears or saliva can have a great impact on one’s life,” researcher Rodrigo Lacruz , a professor of molecular pathobiology at NYU College of Dentistry, said in a news release. “If you can’t produce saliva, it may hamper your speech and your ability to process food, increases your risk for developing cavities, and overall worsens one’s health,” Lacruz added. Researchers decided to focus on salivary gland cells and immune cells to better understand the mechanisms that cause Sjögren’s. They discovered that an inflammatory chemical produced by the immune system, interferon gamma, appears to interfere with saliva production in mice. Interferon gamma levels are typically held in check by T cells that regulate immune response, researchers said. But if a genetic defect inhibits T cell function, too much interferon gamma is produced, resulting in symptoms similar to those of Sjögren’s, results show. “It came down to a defect in regulatory T cells and an over-activation of the cells that produce an inflammatory cytokine called interferon gamma,” Feske said. “Interferon gamma was absolutely critical for causing dysfunction of salivary glands in our mouse model.” Given that, researchers figured that a drug that suppresses interferon action might be able to treat Sjögren’s. Baricitinib is a JAK inhibitor, a class of drugs that suppress immune system signals in the body that result from interferon. Mice given baricitinib had better saliva production and less inflammation, researchers found. To see if this might work in humans, researchers examined blood samples from patients with Sjögren’s. They found a strong correlation between mice and humans regarding the underlying genetics of Sjogren’s, results show. However, clinical trials will be needed to prove that baricitinib or some other JAK inhibitor can effectively treat Sjogren’s, researchers concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 Deals associated with Baricitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10308	Baricitinib	L04AA37	DB11817

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Enthesitis-Related Arthritis	EU	Eli Lilly Nederland BV	21 Sep 2023
Enthesitis-Related Arthritis	IS	Eli Lilly Nederland BV	21 Sep 2023
Enthesitis-Related Arthritis	LI	Eli Lilly Nederland BV	21 Sep 2023
Enthesitis-Related Arthritis	NO	Eli Lilly Nederland BV	21 Sep 2023
Juvenile Idiopathic Arthritis	EU	Eli Lilly Nederland BV	21 Sep 2023
Juvenile Idiopathic Arthritis	IS	Eli Lilly Nederland BV	21 Sep 2023
Juvenile Idiopathic Arthritis	LI	Eli Lilly Nederland BV	21 Sep 2023
Juvenile Idiopathic Arthritis	NO	Eli Lilly Nederland BV	21 Sep 2023
Oligoarticular Arthritis	EU	Eli Lilly Nederland BV	21 Sep 2023
Oligoarticular Arthritis	IS	Eli Lilly Nederland BV	21 Sep 2023
Oligoarticular Arthritis	LI	Eli Lilly Nederland BV	21 Sep 2023
Oligoarticular Arthritis	NO	Eli Lilly Nederland BV	21 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	EU	Eli Lilly Nederland BV	21 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	IS	Eli Lilly Nederland BV	21 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	LI	Eli Lilly Nederland BV	21 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	NO	Eli Lilly Nederland BV	21 Sep 2023
COVID-19	CH	Eli Lilly & Co.	19 Jun 2017
Alopecia Areata	EU	Eli Lilly Nederland BV	13 Feb 2017
Alopecia Areata	IS	Eli Lilly Nederland BV	13 Feb 2017
Alopecia Areata	LI	Eli Lilly Nederland BV	13 Feb 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aicardi-Goutieres Syndrome	Phase 3	JP	Eli Lilly & Co.	27 Oct 2020
Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature	Phase 3	JP	Eli Lilly & Co.	27 Oct 2020
Melorheostosis	Phase 3	JP	Eli Lilly & Co.	27 Oct 2020
Nakajo Syndrome	Phase 3	JP	Eli Lilly & Co.	27 Oct 2020
STING-associated Vasculopathy With Onset in Infancy	Phase 3	JP	Eli Lilly & Co.	27 Oct 2020
Systemic onset juvenile chronic arthritis	Phase 3	JP	Eli Lilly & Co.	12 Feb 2020
Systemic onset juvenile chronic arthritis	Phase 3	AR	Eli Lilly & Co.	12 Feb 2020
Systemic onset juvenile chronic arthritis	Phase 3	AT	Eli Lilly & Co.	12 Feb 2020
Systemic onset juvenile chronic arthritis	Phase 3	BE	Eli Lilly & Co.	12 Feb 2020
Systemic onset juvenile chronic arthritis	Phase 3	BR	Eli Lilly & Co.	12 Feb 2020

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03952559 (BREEZE-AD-PEDS, Pubmed \| J Dermatolog Treat)	Phase 3	Dermatitis, Atopic	467	Baricitinib 4-mg equivalent	vyxgoztlxd(rbwhsrgvdk) = lgjroahemn dchoucvibd (epkzbgpbbl )	Positive	31 Dec 2024
NCT01885078 (RA-BEYOND, Pubmed \| Rheumatology (Oxford)) Manual	Phase 3	Rheumatoid Arthritis	-	Baricitinib 4 mg	biswdyesoa(wbidbsffcc) = plrlubpdvy uwudgsembf (ckfzxralhp ) View more	Positive	01 Oct 2024
				Baricitinib 2 mg	biswdyesoa(wbidbsffcc) = vmhwbysjsh uwudgsembf (ckfzxralhp ) View more
NCT04088409 (CTgov)	Phase 3	Uveitis \| Juvenile Pauciarticular Chronic Arthritis	30	Baricitinib (Baricitinib)	rztqlpsgpb(aqnlvrwkey) = mbaudaozju gqywhutfru (oyxzmocbwy, vremgeufho - nobjtbelsj) View more	-	13 Aug 2024
				Adalimumab (Adalimumab)	cluiboovds(ftirfytznq) = xruopuotqe rglucvpclv (rixraupjhy, muvdndnoym - hzceopduqd) View more
NCT03570749 \| NCT03899259 (BRAVE-AA1; BRAVE-AA2, Pubmed)	Phase 3	Alopecia Areata	131	Baricitinib 4 mg	jpobxhcoew(xmukjgykff) = progressive improvements tpfluxrgmx (tnxiferllz ) View more	Positive	21 Jun 2024
				Baricitinib 2 mg
NCT05188521 (CTgov)	Phase 2	Lichen Planus	12	Baricitinib (LY3009104) 2 mg (Cutaneous LP)	hojzvujbdp(pjvmvnnjyp) = frzjgdbyyo miyicvctqr (bakwciamul, syuhtazwru - jakcgqfoil) View more	-	11 Jun 2024
				Baricitinib (LY3009104) 4 mg (Dose Escalation Extension Group)	rmprenahik(qtazxtyphn) = grnyjpuxcd ngjnkvwxos (idfqbmozud, uvzhwjwntb - eyhrsflsga) View more
RA-BE-REAL (EULAR2024) Manual	Not Applicable	Rheumatoid Arthritis	673	Baricitinib (BARI)	jeuaomylbu(bttbfocyba) = rkommusufi hgmftqxkjq (iozmnmwhcn ) View more	Positive	05 Jun 2024
				Tumor Necrosis Factor Inhibitor (TNFi)	jeuaomylbu(bttbfocyba) = mwqlasskvk hgmftqxkjq (iozmnmwhcn ) View more
EULAR2024 Manual	Not Applicable	Lung Diseases, Interstitial	60	Baricitinib	nlvqwblfhc(mxwoguzrnx) = cyrbniurgv uhzaxepypb (nacnvrafzl ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Rheumatoid Arthritis CGRP	43	Baricitinib	uzavybawzr(cdeeueczdz) = lwaekmiazz bbcavnvmey (jchozyrhxw )	Positive	05 Jun 2024
				Baricitinib (Responder patients)	uzavybawzr(cdeeueczdz) = qmlcyvwhps bbcavnvmey (jchozyrhxw )
EULAR2024	Not Applicable	Rheumatoid Arthritis	219	Baricitinib monotherapy	zktozmkoiq(golwesujal) = No new safety issues were detected during this period of observation tvddzwumdw (ribhfgzuix ) View more	Positive	05 Jun 2024
				Baricitinib and methotrexate combination therapy
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Biologic and targeted synthetic DMARDs	gpxijwrpdb(tywpvjucjt) = qhtwzmftcq dipxshczra (pidtfaifid ) View more	-	05 Jun 2024

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