Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis: an Open-label, Non-inferiority, Randomised Clinical Trial

Uveitis and its complications are thought to account for 10 to 15% of preventable blindness in Western countries. The diagnosis of chronic non-infectious uveitis (CNUI) can be made after exclusion of pseudo uveitis or infectious uveitis, in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment. Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids. The use of ADA has been optimized, in particular through Therapeutic Drug Monitoring (TDM), based on the determination of serum ADA levels and anti-ADA antibodies. Recently, an article showed that a strategy of spacing ADA administrations in RA patients with concentrations >8 μg/mL was not inferior to standard.

Start Date01 Mar 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Saint-Etienne

NCT02586831 / WithdrawnPhase 1/2IIT

A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT06729463 / RecruitingNot ApplicableIIT

IKBKB Gene Polymorphism (Single Nucleotide Polymorphism) (SNP) in Psoriatic and Psoriatic Arthritis Patients and Its Relation With Response to Systemic Biologic Therapy

Psoriasis is a chronic inflammatory skin disease characterized by scaly indurated erythema. It impairs patients' quality of life enormously.
Psoriasis refers to a persistent inflammatory illness of the skin and joints. It also impacts roughly 2%-3% of the inhabitants of the universe

Start Date01 Dec 2024

Sponsor / Collaborator

South Valley University

100 Clinical Results associated with Adalimumab

100 Translational Medicine associated with Adalimumab

100 Patents (Medical) associated with Adalimumab

9,238

Literatures (Medical) associated with Adalimumab

01 Feb 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Predictors of Therapy Success in Weekly Adalimumab for Refractory Uveitis: A Retrospective Cohort Study

Article

Author: Janetos, Timothy M ; Goldstein, Debra A ; Kanwar, Kunal ; Bashey, Saffiya ; Koreishi, Anjum

PURPOSE:

To determine predictors of treatment success after dose escalation of adalimumab, including the measurement of anti-adalimumab antibodies as a predictor of success.

DESIGN:

Retrospective clinical cohort study.

METHODS:

Setting: Single-center academic institution.

STUDY POPULATION:

Patients with noninfectious uveitis who were inadequately controlled or developed recurrent disease on every other week adalimumab and required dose escalation or therapy modification.

OBSERVATION PROCEDURES:

Patients who had anti-adalimumab antibodies checked with resultant low to intermediate levels were compared with patients who had no testing performed before adalimumab dose escalation. Of note, patients with testing and resultant high levels of anti-adalimumab antibodies were not escalated. Predictors of escalation success and utility of antibody testing before escalation were analyzed using Kaplan-Meier survival analysis and Cox proportional hazards models.

MAIN OUTCOME MEASURES:

Treatment success defined as anterior chamber grade ≤0.5+ cell, topical corticosteroids ≤1 drop/d, oral prednisone ≤5 mg/d, resolution of macular edema, and resolution of angiographic signs of inflammation without any addition or escalation of therapy.

RESULTS:

A total of 24 patients had antibodies tested with low to intermediate levels (average: 32.3 ng/mL, range: 0-154 ng/mL), whereas 41 did not have antibody testing. A greater treatment success rate after escalation was observed among the "low antibody" group compared with the "no testing" group (hazard ratio: 2.63, standard error: 1.19, P = .031, 95% CI: 1.09-6.37). Among the entire cohort, patients with panuveitis (n = 14) had a lower treatment success rate compared with the reference of anterior uveitis (n = 26) (hazard ratio: 0.09, standard error: 0.11, P = .05, 95% CI: 0.01-0.99).

CONCLUSIONS:

Patients with low anti-adalimumab antibodies had a greater treatment success than patients in whom antibodies were not checked. This suggests a utility to checking antibodies before dose escalation and that low levels of antibodies may confer a success advantage. Overall, patients with panuveitis had a lower rate of success after escalation while patients with anterior uveitis patients had a very high rate of success suggesting that certain disease characteristics may guide clinicians when determining who to escalate versus changing therapy.

01 Jan 2025·Methods in molecular biology (Clifton, N.J.)

Codon and Signal Peptide Optimization to Enhance Therapeutic Antibody Production from CHO Cells

Article

Author: Oli, Deepesh ; Srila, Witsanu ; Yamabhai, Montarop

A simple and rapid method for reproducible transient expression experiments to quickly identify the best conditions before the development of a stable CHO cell line is described, using adalimumab as a model antibody. Firstly, the signal peptide (SP) is optimized using different in silico programs, of which those having a D score of more than 0.85 will be selected. A list of useful SPs is provided. Next, guidelines for selecting the codon optimization algorithm is provided based on a CAI value of more than 0.95. After that, the codon optimized genes of the heavy chain (HC) and light chain (LC) of an antibody with different SPs are engineered into an expression vector and the two recombinant plasmids are co-transfected into a CHO cell line of interest. The antibody titer, specific productivity (Qp), and viable cell density (VCD) are then checked by ELISA and flow cytometry analysis. The best SP pairs can then be used for the development of stable CHO cell lines.

01 Jan 2025·TALANTA

Determination of adalimumab by HPLC with fluorescence detection using the König reaction

Article

Author: Ogra, Yasumitsu ; Mochizuki, Ryu ; Toida, Toshihiko

Monoclonal antibody drugs (mAb) are widely used to treat various diseases. Keeping quality of mAbs is crucial to maximize efficacy and minimize adverse effects. To this end, mAb content in the drug product must be precisely quantified. As methods for the determination of mAbs, absorbance measurement at 280 nm, the ligand binding assay based on ELISA, or the LC-MS/MS method based on the surrogate peptide approach is usually used. However, these methods have drawbacks in terms of selectivity, reliability, and cost, respectively. The present method is based on the surrogate peptide approach where a peptide specific to the mAb is determined by a post-column derivatization LC system with fluorescence detection and the König reaction, which is usually used for the detection of cyanide and its derivatives. The detection mechanism was the production of cyanide from the surrogate peptide by chloramine T and the generated cyanide was detected by the König reaction. In this study, adalimumab was used as a model target protein. The calculated LOD and LOQ of the present method were 0.31 μg/mL and 0.94 μg/mL, respectively. The intra-day accuracies and precisions were 127.1 % and 2.94 % for 5 μg of adalimumab and 101.6 % and 10.2 % for 50 μg of adalimumab, respectively. The inter-day accuracies and precisions were 121.8 % and 5.71 % for 5 μg of adalimumab and 101.8 % and 6.98 % for 50 μg of adalimumab, respectively. Our quantitatively determined amount of adalimumab in Humira® was in good agreement with the specified value. This method only requires a conventional LC system, not an LC-MS/MS system. By extending the application of the König reaction, we open the door to a new surrogate peptide approach for the determination of proteins including monoclonal antibody drugs.

995

News (Medical) associated with Adalimumab

04 Dec 2024

·www.echemi.com

Pharmaceutical Giants Surge: Merck Revenue Soars 18%! Eli Lilly Reports $31.5 Billion in Q1-3 Revenue

Merck's revenue grew by 18% in the third quarter, with projected annual sales of Keytruda exceeding $29 billion, potentially reaching $30 billion. The 15-valent pneumonia vaccine generated $239 million in revenue, a 13% increase. The 21-valent pneumonia vaccine performed well in the market. However, sales of the 9-valent HPV vaccine in China declined by 10%. Sales of the cardiovascular drug Winrevair reached $149 million, with approximately 1,700 new patients in the third quarter. Despite a downward adjustment in annual revenue guidance, the strong performance of Keytruda and investment in R&D provide support for Merck's future growth. Eli Lilly reported $11.44 billion in revenue for the third quarter, a 20% increase, with a net profit of $970 million. Total revenue for the first three quarters reached $31.5 billion, a 27% increase, with net profit at $6.18 billion. Sales of innovative drugs were strong, particularly tirzepatide, which achieved $11 billion in sales during the first three quarters. Eli Lilly's launch of innovative drugs in cardiovascular, immunology, and oncology fields supports its revenue growth. Other multinational pharmaceutical companies, such as Novartis, Sanofi, and AstraZeneca, also achieved double-digit growth due to the release of innovative drugs, market expansion, and cost control. Johnson & Johnson, AbbVie, and BMS experienced slight growth in the third quarter, maintaining their positions in the top ten. GSK dropped out of the top ten due to declining performance. Johnson & Johnson reported $22.5 billion in revenue, a 5.2% increase, with pharmaceutical business growth of 4.9% and medical device business growth of 5.8%. Sales of the BCMA CAR-T therapy in collaboration with Legend Biotech reached $629 million, an increase of 84.3%. Johnson & Johnson faced challenges, with self-immunity business growth slowing to 1% and ustekinumab sales declining by 1.2%. However, the oncology business grew by 17.2%, becoming a new driver of performance. AbbVie reported $41.232 billion in revenue for the first three quarters, an increase of about 3%. The patent cliff effect of Humira caused a 37.2% decline in sales, but strong sales of Skyrizi and Rinvoq supported performance. GSK's revenue for the third quarter was £8.012 billion, a decrease of 1.6%. The vaccine sector performed poorly, with sales of Arexvy and Shingrix declining. Specialty pharmaceuticals grew by 19%, and oncology grew by 94%. GSK plans to increase investment in specialty pharmaceuticals, seeking to revive its vaccine sector and expand its partnership network. The global pharmaceutical industry shows diversified performance, with concerns arising from the underperformance of some companies. Pharmaceutical companies need to strengthen innovation, international cooperation, and marketing to ensure long-term stable development. Pfizer, Johnson & Johnson, and AbbVie performed outstandingly, while companies like GSK provide insights for adjustment and transformation.

VaccineFinancial StatementDrug Approval

02 Dec 2024

·www.prnewswire.com

First Shipment of Henlius Trastuzumab to U.S.

HANQUYOU shipped to the United States, offering high-quality, affordable treatment options to North American patients - Henlius' first product exported to the U.S., enabling commercial supply to regions including China, Europe, Latin America, the Middle East, North America, and Southeast Asia - HANQUYOU approved in 50 countries and regions, benefiting over 220,000 patients - SHANGHAI, Dec. 2, 2024 /PRNewswire/ -- On November 29, 2024, Henlius' independently developed and produced trastuzumab biosimilar, HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac® in Europe), departed from Henlius' Songjiang First Plant, heading to the U.S. This milestone marks the company's first commercial supply to North America, representing a significant breakthrough in its global expansion. With this achievement, Henlius has successfully extended its commercial supply network to include China, Europe, Latin America, the Middle East, North America and Southeast Asia. Ms. Wei Huang, President of Henlius, stated that, "The U.S., as the world's largest biopharmaceutical market, imposes stringent requirements on drug supply systems and the comprehensive strengths of companies. The successful entry of HANQUYOU into the U.S. market not only expands our international footprint but also lays a solid foundation for the globalization of our other products. Since the commercial launch of HANQUYOU in 2020, we have successfully shipped approximately 6.5 million units globally, continuously enhancing our production and supply capabilities in our relentless effort to benefit more patients." Dr. Frank Ye, Vice President and Chief Quality Officer, stated that, "High quality is the key to establishing a firm foothold on the global stage, earning customer trust, and enabling products to succeed in international markets. More importantly, it serves as the solid foundation for us to benefit more patients worldwide as medicine quality directly impacts patient lives. At Henlius, we remain committed to upholding the highest international standards of quality, delivering high-quality biologics to even more patients." HANQUYOU is a China-developed mAb biosimilar approved in China, the European Union (EU) and U.S. It is now approved in 50 countries and regions including the U.S., United Kingdom (UK), Canada, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, and it is reimbursed nationally in countries and regions including China, the UK, France and Germany. To date, HANQUYOU has benefited over 220,000 patients with HER2 positive breast and gastric cancer worldwide. HANQUYOU's extensive global reach is a testament to Henlius' relentless pursuit of excellence in product quality. Henlius has established a quality management system that meets international standards. Its three production sites – Xuhui Facility, Songjiang First Plant and Songjiang Second Plant – along with their quality management systems, have successfully passed approximately 100 inspections and audits conducted by regulatory agencies and international business partners across various countries. The company has been GMP-certified by China, the U.S., the EU as well as PIC/S member countries such as Indonesia and Brazil, equipped with a solid foundation for the global supply of its products. The successful U.S. launch of HANQUYOU also dates from Henlius' exclusive partnership with Intas and its subsidiary, Accord. In collaboration with leading global biopharmaceutical companies such as Accord, Abbott, Eurofarma, and KGbio, Henlius has proactively established a global commercial layout for HANQUYOU. Looking ahead, Henlius will continue to strengthen its collaborations with global partners to accelerate the global launch of more high-quality medicines, benefiting more patients worldwide. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalBiosimilarImmunotherapy

02 Dec 2024

·www.prnewswire.com

Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA® (guselkumab)

Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis SPRING HOUSE, Pa., Dec. 2, 2024 /PRNewswire/ -- Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).a The PsO submission is based on data from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and bridging pharmacokinetic (PK) data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. The jPsA submission is based on PK extrapolation analyses from adult PsA studies (DISCOVER 1 and 2) and TREMFYA efficacy and safety data from the PROTOSTAR study.b "This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases," said Liza O'Dowd, M.D., Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "There is a critical gap in the treatment of children and adolescents with these skin and joint conditions, where debilitating symptoms can present challenges related to physical appearance and ability to function. At Johnson & Johnson, we are working to address this gap by investigating the efficacy and well-characterized safety profile of TREMFYA for pediatric patients." TREMFYA® is the first approved monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of immune-mediated diseases such as plaque PsO and PsA. Editor's Notes: ABOUT PEDIATRIC PLAQUE PSORIASIS Plaque psoriasis (PsO) is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.1 Almost one-third of PsO cases begin in childhood, with roughly 20,000 children under 10 diagnosed with psoriasis each year.1 Having visible skin disease can be highly stressful for children and adolescents and can have a long-term impact on those affected.2 ABOUT JUVENILE PSORIATIC ARTHRITIS Juvenile psoriatic arthritis (jPsA) is a form of juvenile idiopathic arthritis (JIA) characterized by chronic joint inflammation, swelling and psoriasis. Juvenile PsA is relatively rare, accounting for approximately 5% of the JIA population. In many cases, the skin manifestations start before the arthritis.3 ABOUT THE PHASE 3 PROTOSTAR STUDY ( NCT03451851 ) PROTOSTAR is a Phase 3, multicenter, randomized, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered TREMFYA® for the treatment of chronic plaque psoriasis in pediatric patients six years of age and older. Co-primary endpoints of the study were Investigator's Global Assessment (IGA) 0/1 and PASI 75 at Week 16.4 ABOUT THE PHASE 3 VOYAGE STUDIES ( NCT02207231 and NCT02207244 ) VOYAGE 1 and 2 were Phase 3 randomized, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of TREMFYA® compared with placebo and adalimumab in adults with moderate to severe plaque PsO. The co-primary endpoints of the studies were the proportions of patients receiving TREMFYA® versus patients receiving placebo achieving Investigator's Global Assessment (IGA) 0/1 (clear/almost clear skin) and PASI 90 at week 16.5,6 ABOUT THE PHASE 3 DISCOVER STUDIES ( NCT03162796 and NCT03158285 ) DISCOVER-1 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of TREMFYA® administered by subcutaneous injection in participants with active PsA, including those previously treated with one to two tumor necrosis factor inhibitors (TNFi). The primary endpoint was response of ACR20 at week 24.7 DISCOVER-2 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of TREMFYA® administered by subcutaneous injection in biologic-naïve patients with active PsA. The primary endpoint was response of ACR20 at week 24.8 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis.9 TREMFYA® is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA® (guselkumab)? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting , by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 National Psoriasis Foundation. About psoriasis. Available at: . Accessed October 2024. 2 Bronckers IM, Paller AS, van Geel MJ, van de Kerkhof PC, Seyger MM. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. Paediatr Drugs. 2015 Oct;17(5):373-84. doi: 10.1007/s40272-015-0137-1. 3 Brunello, Francesco et al. New Insights on Juvenile Psoriatic Arthritis. Frontiers in pediatrics. 2022. Available at: (JPsA)%20is,Idiopathic%20Arthritis%20(JIA)%20population. Accessed October 2024. 4 ClinicalTrials.gov.A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR). Identifier: NCT03451851. Available at: 5 Clinicaltrials.gov. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1). Identifier NCT02207231. . Accessed October 2024. 6 Clinicaltrials.gov. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment (VOYAGE 2). Identifier NCT02207244. . Accessed October 2024. 7 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-Tumor Necrosis Factor (TNF) Alpha Agent(s) (DISCOVER 1). Identifier: NCT03162796. Available at: . Accessed October 2024. 8 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis. Identifier: NCT03158285. Available at: . Accessed October 2024. 9 TREMFYA® Prescribing Information. Available at: . Accessed October 2024. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultImmunotherapy

100 Deals associated with Adalimumab

External Link

KEGG	Wiki	ATC	Drug Bank
D02597	Adalimumab	L04AB04	DB00051

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pyoderma Gangrenosum	JP	AbbVie GK	27 Nov 2020
Pustular psoriasis	JP	AbbVie GK	23 Mar 2018
Behcet Syndrome	JP	AbbVie GK	17 Jun 2016
Psoriasis vulgaris	JP	AbbVie GK	17 Jun 2016
Colitis, Ulcerative	AU	AbbVie Pty Ltd.	10 Dec 2003
Hidradenitis Suppurativa	AU	AbbVie Pty Ltd.	10 Dec 2003
Non-infectious anterior uveitis	AU	AbbVie Pty Ltd.	10 Dec 2003
Psoriasis	AU	AbbVie Pty Ltd.	10 Dec 2003
Enthesitis-Related Arthritis	EU	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Enthesitis-Related Arthritis	IS	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Enthesitis-Related Arthritis	LI	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Enthesitis-Related Arthritis	NO	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Juvenile Idiopathic Arthritis	EU	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Juvenile Idiopathic Arthritis	IS	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Juvenile Idiopathic Arthritis	LI	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Juvenile Idiopathic Arthritis	NO	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	EU	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	IS	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	LI	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	NO	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized Pustular Psoriasis	Phase 3	-	AbbVie, Inc.	28 Sep 2015
Oral Ulcer	Phase 3	US	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	AT	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	BE	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	CA	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	CZ	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	DK	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	FR	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	DE	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	HU	AbbVie, Inc.	01 May 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EURETINA2024	Not Applicable	Non-infectious anterior uveitis	-	Adalimumab	hwcjczvxrm(oiyvietpdk) = Multiple Sclerosis 1 year after adalimumab use rjjxmhezmh (mttwbrtvxf )	-	19 Sep 2024
EURETINA2024	Not Applicable	Uveitis	-	Adalimumab	dasbnkfjnt(sxwnemjnnx) = bcgxrkares fgqvonqjte (jwjwfipyrl, 116.73) View more	-	19 Sep 2024
NCT02451748 (CTgov)	Phase 4	Rheumatoid Arthritis	32	Lab Work (DMARD's Responder and Non-Responder)	iauntptkpp(eabltbhfto) = datfebuisr rwfilynrkg (qwezgupmij, lvtyfxupmz - qisopqonts) View more	-	10 Jul 2024
				Naproxen+Medrol+Hydroxychloroquine+humira+Prednisone+Lab Work+Triamcinolone+Sulfasalazine+Certolizumab pegol (CDP870, tradename Cimzia)+Methotrexate+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol))	jcpkydhhyw(duilwjwdni) = hmryxibuzs nyuutyknok (ruuuwwridd, ypwgtlxequ - vbsiiiilkb) View more
EULAR2024	Not Applicable	Arthritis, Psoriatic	-	Secukinumab	ahxgwegqqw(ifrljnlpgb) = iyqezyrpci zgamosqqnr (lptgzuslqy ) View more	Positive	05 Jun 2024
				Adalimumab	bhmxcoydqd(zjaekkrjhf) = ojuhzlplyi zbvldkeege (srvcthdzii ) View more
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Biologic and targeted synthetic DMARDs	tjlwaiuhoz(mlsoncinpi) = jzcjidghyr ovawfdzgxu (gdmsamhbwv ) View more	-	05 Jun 2024
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	biologic drugs (Obese patients)	qcmiynppys(kcscrxpgzx) = buhjazxknj lxhxpytcql (vanfobdlyn ) View more	Negative	05 Jun 2024
				biologic drugs (Non-obese patients)	qcmiynppys(kcscrxpgzx) = oczdpzfeqg lxhxpytcql (vanfobdlyn ) View more
EULAR2024	Not Applicable	IL-17A	135	Adalimumab (ADA)	sndgmfpokr(klmawdtabd) = seobzvsnxp yriqqpsyyb (ukstwoerep )	Positive	05 Jun 2024
				Infliximab (IFX)	sndgmfpokr(klmawdtabd) = ihpukrsjnd yriqqpsyyb (ukstwoerep )
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	Rituximab	wzodjecggk(qsgmiotzko) = frmsdlmqkf uwbfwnxlmz (mggnwetnxe ) View more	-	05 Jun 2024
				Tocilizumab	wzodjecggk(qsgmiotzko) = oikmukqsob uwbfwnxlmz (mggnwetnxe ) View more
ISN WCN2024	Not Applicable	Glomerulonephritis, Membranous \| Rheumatoid Arthritis	-	Adalimumab	tgviytbbni(adhwrovmwx) = xfcsccjkuo zugaeaxiph (ykxfwtqaiz ) View more	Negative	01 Apr 2024
ACR2023	Not Applicable	Rheumatoid Arthritis	-	Tapering ADL first	coujcywvtn(cykvyjiavf) = jrajbsgpsa iaqmxshhzp (xzikootipo )	-	13 Nov 2023

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