Johnson & Johnson showcases breadth of rheumatology innovation at ACR Convergence 2026 with 43 presentations, including late-breaking data on ICOTYDE^® (icotrokinra) in psoriatic arthritis

New Brunswick, N.J. (October 22, 2026) - Johnson & Johnson (NYSE: JNJ) announced today that 43 presentations showcasing the Company’s leadership in rheumatology and its portfolio and pipeline will be featured at the American College of Rheumatology (ACR) Convergence 2026. The program includes a late-breaking presentation featuring investigational data on ICOTYDE^® (icotrokinra) in adults with active psoriatic arthritis (PsA).^a New research evaluating nipocalimab across autoantibody-driven diseases will also be featured, including four oral presentations across Sjögren’s disease (SjD), systemic lupus erythematosus (SLE), and warm autoimmune hemolytic anemia (wAIHA). Multiple TREMFYA^® (guselkumab) presentations will highlight data in joint pain, skin symptoms, and overall disease activity across certain patient types and domains in moderate-to-severe plaque psoriasis (PsO) and active PsA, showing the therapeutic value of TREMFYA across psoriatic disease.

“The breadth of our research at ACR reflects our ambition to raise the standard of care across rheumatic diseases, particularly where meaningful unmet needs remain,” said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. “Across our portfolio and pipeline, we are generating evidence that helps address critical gaps in care, from advancing treatment possibilities in psoriatic disease to deepening our understanding of disease biology in Sjögren’s disease and systemic lupus erythematosus. Together, these data reinforce our commitment to delivering targeted approaches.”

The list of J&J-sponsored abstracts being presented at ACR includes:

TREMFYA

ICOTYDE

Nipocalimab

Other studies

Editor’s notes:
a. ICOTYDE is not approved in PsA.

About plaque psoriasis
Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.¹ It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.² Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.² Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.³ Living with plaque PsO can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life.⁴ Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.⁵

About psoriatic arthritis
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).^6,7,8 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.⁹ Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.¹⁰ In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.¹¹ Studies show up to 30% of people with plaque PsO also develop PsA.¹²

About Sjögren’s disease
Sjögren’s disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.¹³ It is a chronic autoantibody-driven disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.¹⁴ SjD is characterized by autoantibody production, chronic inflammation and lymphocytic infiltration of exocrine glands.¹⁵Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.¹⁶ More than 50% of SjD patients have a moderate-to-severe form of the condition, and cumulative disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus (SLE).^17,18,19 It is usually associated with impaired quality of life, and in up to approximately half of patients, a loss of functional capacity that can result in an inability to work due to a disability.^18,19,20

About systemic lupus erythematosus
Systemic lupus erythematosus (SLE) is a chronic autoantibody-driven disease that occurs when the body’s immune system mistakenly attacks various tissues and organ systems.^21,22 This can lead to inflammation and damage in many parts of the body, including the skin, joints, heart, lungs, kidneys and brain.²³ SLE affects nine times more women than men, often striking initially between the ages of 15-44.²⁴ In addition to systemic organ damage, other complications of SLE can include end-stage renal failure, scarring cutaneous lesions, neurological damage and various forms of cardiovascular disease.²⁵ People living with SLE often face reduced health-related quality of life, due to severe fatigue, mood disturbances, joint pain, swelling and rashes, including the hallmark butterfly-shaped facial rash, as well as complications of long-term glucocorticoid use.²⁶ Severe fatigue is the most widely reported and debilitating symptom of SLE, affecting up to 80% of people with SLE.²⁷ SLE is the most common form of lupus, affecting 3 to 5 million people worldwide, approximately 70% of lupus cases.^28,29It is estimated that 450,000 people in the United States are affected by SLE.³⁰

About warm autoimmune hemolytic anemia (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia.³¹ Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.^32,33 This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.^33,34 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.³⁵

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 cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate TREMFYA 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 and children six years and older who also weigh at least 40 kg 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 and children six years and older who also weigh at least 40 kg with active psoriatic arthritis.
• adults with moderately to severely active ulcerative colitis.
• adults with moderately to severely active Crohn’s disease.

TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn’s disease and adults with moderate-to-severe ulcerative colitis.

The legal manufacturer for TREMFYA is Janssen Biotech, Inc.

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA. For more information, visit: www.tremfya.com.

About ICOTYDE (icotrokinra)
ICOTYDE (icotrokinra) is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO.^36,37,38 ICOTYDE binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.³⁹ Clinical significance of these findings is unknown.

ICOTYDE is currently approved in the U.S. for the treatment of moderate-to-severe plaque PsO in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once daily upon waking with water on an empty stomach, at least 30 minutes before eating.⁴⁰

ICOTYDE is also approved in Europe, Japan and China for the treatment of adults and adolescents with psoriasis.

ICOTYDE was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop ICOTYDE in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.^41,42,43

ICOTYDE is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.^44,45,46,47

About IMAAVY (nipocalimab-aahu)
IMAAVY^® is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving B-cell function based on in vitro and/or in vivo studies.^48,49 IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.[l] IMAAVY is also approved for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.⁵⁰

Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus. ^{51,52,53,54,55,56,57,58}

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

• EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025
• U.S. FDA Fast Track designation in HDFN, and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren’s disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026
• U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
• U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024
• U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026

The legal manufacturer for IMAAVY is Janssen Biotech, Inc.

TREMFYA IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TREMFYA?

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:

· Liver problems. With the treatment of Crohn’s disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA. Your healthcare provider may stop treatment with TREMFYA if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:

Do not use 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. Children should be brought up to date with all vaccines before starting 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 www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. 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, stomach pain,bronchitis feeling very tired (fatigue), fever (pyrexia), and skin rash.
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 www.fda.gov/medwatch, or call 1-800-FDA-1088.

Dosage Forms and Strengths: TREMFYA is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.

ICOTYDE INDICATION AND IMPORTANT SAFETY INFORMATION
WHAT IS ICOTYDE (icotrokinra)?
ICOTYDE 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ICOTYDE?

· Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE 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 ICOTYDE.
Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including:

Before taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection that does not go away or that keeps coming back.
• have tuberculosis (TB) or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.

Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com.
· are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE.

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 ICOTYDE?

ICOTYDE may cause serious side effects. See “What is the most important information I should know about ICOTYDE?”

The most common side effects of ICOTYDE include:

These are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

How should I take ICOTYDE?

• Take ICOTYDE exactly as your healthcare provider tells you to take it.
• Take ICOTYDE 1 time a day when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.
• If you have difficulty swallowing tablets, ICOTYDE can be dispersed in water. For more information, please read the Medication Guide.
• If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day.

Please read the full Prescribing Information, including Medication Guide, for ICOTYDE and discuss any questions that you have with your doctor.
cp-564097v2

IMAAVY IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IMAAVY?

IMAAVY is a prescription medicine that may cause serious side effects, including:

· Infections. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you have any of the following infection symptoms:

· Allergic (hypersensitivity) reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:

· Infusion-related reactions. Tell your healthcare provider right away if you get any of these symptoms during or within a few days after your IMAAVY infusion:

Do not receive IMAAVY if you have a history of a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis. Refer to the Patient Information section of the Prescribing Information for a complete list of ingredients in IMAAVY.

Before receiving IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:
· have had an allergic reaction to IMAAVY.
· have or had any recent infections or symptoms of infection.
· have or had shingles (herpes zoster) or mono (mononucleosis caused by Epstein-Barr virus).
· have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.
· are pregnant or plan to become pregnant. It is not known if IMAAVY will harm your unborn baby.
Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY. If IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY, your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736.
· are breastfeeding or plan to breastfeed. IMAAVY can pass into your breast milk. It is not known if IMAAVY will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with IMAAVY.

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 IMAAVY?

IMAAVY may cause serious side effects. See “What is the most important information I should know about IMAAVY?”

The most common side effects in people with gMG treated with IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.

The most common side effects in people with wAIHA treated with IMAAVY include: peripheral edema (swelling in your hands, ankles, or feet), diarrhea, and pyrexia (fever).

These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for IMAAVY and discuss any questions you have with your doctor.

Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.

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 https://www.jnj.com/ or at www.innovativemedicine.jnj.com

Follow us at @JNJInnovMed.

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to nipocalimab, ICOTYDE and 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 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 most recent Annual Report on Form 10-K, 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 www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES:

¹National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed October 2026.
² National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed October 2026.
³ National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed October 2026.
⁴ National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed October 2026.
⁵ National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed October 2026.
⁶ Donvito T., CreakyJoints: What Is Dactylitis? The ‘Sausage Finger’ Swelling You Should Know About. Accessed October 2026.
⁷ Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed.ncbi.nlm.nih.gov/31102105/. Accessed October 2026.
⁸ Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed October 2026.
⁹ National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed October 2026.
¹⁰Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed October 2026.
¹¹ Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed October 2026.
¹² ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: https://clinicaltrials.gov/study/NCT04882098. Accessed October 2026.
¹³ Huang H, et al. Mortality in patients with primary Sjögren’s syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038. doi: 10.1093/rheumatology/keab364. PMID: 33878179
¹⁴ Beydon, M., et al. Epidemiology of Sjögren syndrome. Nat Rev Rheumatol. 2024 Mar;20(3):158-169. doi: 10.1038/s41584-023-01057-6.
¹⁵ Meudec L, Nocturne G, Mariette X. Update on the Aetiopathogenesis of Sjögren Disease: From Interferon Signaling to Epithelial Dysfunction. J Clin Med. 2026 Mar 4;15(5):1945. doi: 10.3390/jcm15051945
¹⁶ Mayo Clinic. Sjogren’s syndrome. Available at: https://www.mayoclinic.org/diseases-conditions/sjogrens-syndrome/symptoms-causes/syc-20353216. Last accessed: October 2026.
¹⁷ Lim ZFS, et al. Regulatory T cell therapy for Sjögren’s disease: From pathogenesis to targeted treatment. J Transl Autoimmun. 2025 Aug 26;11:100311. doi: 10.1016/j.jtauto.2025.100311.
¹⁸ Carsons SE, Patel BC. Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431049/
¹⁹Hackett KL, et al. Impaired functional status in primary Sjögren’s syndrome. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1760-4.
²⁰ Meijer JM, et al. Health-related quality of life, employment and disability in patients with Sjogren’s syndrome. Rheumatology (Oxford). 2009 Sep;48(9):1077-82. doi: 10.1093/rheumatology/kep141. Epub 2009 Jun 24. PMID: 19553376.
²¹ Lupus Foundation of America. Understanding Lupus https://www.lupus.org/understanding-lupus. Last accessed: October 2026.
²²Kawka L, et al. Fatigue in Systemic Lupus Erythematosus: An Update on Its Impact, Determinants and Therapeutic Management. J Clin Med. 2021 Sep
²³ National Institute of Arthritis and Musculoskeletal and Skin Disease. (2022) Systemic Lupus Erythematosus (Lupus). https://www.niams.nih.gov/health-topics/lupus. Last accessed: October 2026.
²⁴ Guéry JC. Why Is Systemic Lupus Erythematosus More Common in Women? Joint Bone Spine. 2019 May;86(3):297-299. doi: 10.1016/j.jbspin.2018.12.004. Epub 2018 Dec 22. PMID: 30584922.
²⁵ Lupus Foundation of America. Lupus facts and statistics. https://www.lupus.org/resources/lupus-facts-and-statistics. Last accessed: October 2026.
²⁶Centers for Disease Control and Prevention. (2024). Symptoms of lupus. https://www.cdc.gov/lupus/signs-symptoms/. Last accessed: October 2026.
²⁷Lupus Foundation of America. Understanding the Invisible Impact of Lupus. Available at: https://www.lupus.org/resources/understanding-the-invisible-impact-of-lupus. Last accessed: October 2026.
²⁸ Tian, J., Zhang, D., Yao, X., Huang, Y., & Lu, Q. (2023). Global epidemiology of systemic lupus erythematosus: A comprehensive systematic analysis and modelling study. Annals of the Rheumatic Diseases, 82(3), 351–356. https://doi.org/10.1136/ard-2022-223035
²⁹Lupus Foundation of America. Lupus facts and statistics. https://www.lupus.org/resources/lupus-facts-and-statistics. Last accessed: October 2026.
³⁰ Wang, Y., Hester, L. L., Lofland, J., Rose, S., Karyekar, C.S., Kern, D.M., Blacketer, M., Davis, K., & Shields-Tuttle, K. (2022). Update on the prevalence of diagnosed systemic lupus erythematosus (SLE) by major health insurance types in the US in 2016. BMC Research Notes, 15, 5. https://doi.org/10.1186/s13104-021-05877-1
³¹ National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: October 2026.
³² National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: October 2026.
³³ Tranekær S, Hansen DL, Frederiksen H. Epidemiology of Secondary Warm Autoimmune Haemolytic Anaemia-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Mar 17;10(6):1244. doi: 10.3390/jcm10061244. PMID: 33802848; PMCID: PMC8002719.
³⁴ Cherif, H., Cai, Q., Crivera, C., Leon, A., Rahman, I., Leval, A., Noel, W. and Kjellander, C. (2024), Overall Survival and Treatment Patterns Among Patients With Warm Autoimmune Hemolytic Anemia in Sweden: A Nationwide Population-based Study. Eur J Haematol. https://doi.org/10.1111/ejh.14311.
³⁵ Fattizzo B, Barcellini W. New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfusion Medical Reviews, Vol. 36, Issue 4. October 2022 https://doi.org/10.1016/j.tmrv.2022.08.001.
³⁶ Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.
³⁷ Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
³⁸ Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.
³⁹ Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.
⁴⁰ICOTYDE™ prescribing information.
⁴¹ Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed October 2026.
⁴² Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed October 2026.
⁴³Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed October 2026.
⁴⁴ Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. https://clinicaltrials.gov/study/NCT06878404. Accessed October 2026.
⁴⁵ A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. https://clinicaltrials.gov/study/NCT06807424. Accessed October 2026.
⁴⁶ Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748.
⁴⁷ Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn’s Disease (ICONIC-CD). Identifier NCT07196722. https://clinicaltrials.gov/study/NCT07196722. Accessed October 2026.
⁴⁸ Ling LE., et al. M281, an anti‐fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first‐in‐human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
⁴⁹Cossu M et al. A randomized, open-label study on the effect of nipocalimab vaccine response in healthy participants. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
⁵⁰ IMAAVY^® U.S. Prescribing Information.
⁵¹ ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: October 2026.
⁵² ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: October 2026.
⁵³ ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: October 2026.
⁵⁴ ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: October 2026.
⁵⁵ ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: October 2026.
⁵⁶ ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: October 2026.
⁵⁷ ClinicalTrials.gov Identifier: NCT06741969 Available at: https://clinicaltrials.gov/study/NCT06741969 Last accessed: October 2026.
⁵⁸ ClinicalTrials.gov Identifier: NCT07438496 Available at: https://clinicaltrials.gov/study/NCT07438496 Last accessed: October 2026.