Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) reported late-breaking Phase 2 JASMINE data showing nipocalimab met the primary endpoint in adults with moderate-to-severe systemic lupus erythematosus (SLE).

At 24 weeks, more patients on nipocalimab 15 mg/kg plus background therapy achieved an SRI-4 response than placebo. At 52 weeks, higher SRI-4 and LLDAS rates were maintained, especially in autoantibody-positive patients. The safety profile was consistent with prior studies, with no new safety signals. Nipocalimab has FDA Fast Track Designation in SLE and is being further evaluated in the ongoing Phase 3 GARDENIA study.

Positive

• Primary endpoint met: higher 24-week SRI-4 response with nipocalimab 15 mg/kg vs placebo (53.5% vs 46.7%)
• Week 52 SRI-4 response higher with nipocalimab vs placebo (53.6% vs 39.7%)
• Week 52 LLDAS rates higher with nipocalimab vs placebo (37.5% vs 20.5%)
• Stronger Week 52 responses in predefined autoantibody-positive population (SRI-4 58.2% vs 36.1%; LLDAS 38.9% vs 18.0%)
• No new safety signals; safety profile consistent with previous nipocalimab studies
• Nipocalimab received FDA Fast Track Designation for SLE and has an ongoing Phase 3 trial

Negative

• Nipocalimab is not FDA-approved for SLE and remains in clinical development
• Common adverse reactions in SLE patients on nipocalimab (≥10%) included nasopharyngitis, headache, urinary tract infection and nausea

News Market Reaction – JNJ

+0.16%

+0.16% Session close to close

In the Jun 3 session, JNJ gained 0.16%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details robust Phase 2 JASMINE results for nipocalimab in SLE, with higher SRI‑4 a...

Analysis

This announcement details robust Phase 2 JASMINE results for nipocalimab in SLE, with higher SRI‑4 and LLDAS responses at 24 and 52 weeks and no new safety signals. It extends earlier topline findings and follows an FDA Fast Track designation, while Phase 3 GARDENIA recruitment continues. Historically, JNJ’s clinical headlines produced small average moves of -0.38%, so investors may focus on confirmatory Phase 3 outcomes, regulatory interactions, and how these data integrate into the company’s broader immunology portfolio.

Key Figures

SRI-4 response Week 24: 53.5% vs 46.7% Autoantibody+ SRI-4: 58.2% vs 36.1% Autoantibody+ LLDAS: 38.9% vs 18.0% +5 more

8 metrics

SRI-4 response Week 24 53.5% vs 46.7% Nipocalimab 15 mg/kg vs placebo plus background medication

Autoantibody+ SRI-4 58.2% vs 36.1% Autoantibody-positive subgroup at Week 52 vs placebo

Autoantibody+ LLDAS 38.9% vs 18.0% LLDAS achievement at Week 52 vs placebo

Week 52 SRI-4 53.6% vs 39.7% Overall SRI-4 response at Week 52 vs placebo

Week 52 LLDAS 37.5% vs 20.5% LLDAS achievement at Week 52 vs placebo

Treatment duration 24 weeks and 52 weeks Primary endpoint at Week 24 with data through Week 52

Dose level 15 mg/kg Nipocalimab dose group with reported efficacy and safety

Autoantibody prevalence ~80% Estimated share of SLE patients who are autoantibody-positive

Previous Clinical trial Reports

5 past events · Latest: May 05 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 05	Robotic system study	Positive	+0.6%	OTTAVA robotic system met safety and performance endpoints in gastric bypass trial.
Apr 10	IOL clinical data	Positive	-1.2%	TECNIS PureSee IOL data showed strong vision outcomes and high satisfaction.
Mar 03	Nipocalimab Fast Track	Positive	-0.7%	Nipocalimab received FDA Fast Track designation for SLE based on Phase 2 data.
Jan 06	Nipocalimab topline SLE	Positive	+0.2%	Phase 2b JASMINE topline SLE results met primary and key secondary endpoints.
Dec 09	Myeloma Phase 3 data	Positive	-0.8%	MajesTEC-3 showed superior survival and responses vs standard RRMM regimens.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial headlines for JNJ have often seen mild downside reactions: across 5 tagged events the average move was -0.38%, with more divergences than alignments on positive data.

Recent Company History

Recent clinical news for Johnson & Johnson has focused on devices, ophthalmology and immunology. In January 2026, topline Phase 2b JASMINE data for nipocalimab in SLE met its primary endpoint and supported a Phase 3 program, followed by a March 3, 2026 Fast Track designation for SLE. Additional positive clinical updates for OTTAVA and TECNIS PureSee, and strong MajesTEC-3 multiple myeloma data, produced a mixed trading record. Today’s detailed 52‑week JASMINE results extend that SLE narrative with longer-term efficacy and safety.

Key Terms

neonatal Fc receptor (FcRn), immunoglobulin G (IgG), SLE Responder Index 4 (SRI-4), Lupus Low Disease Activity State (LLDAS), +4 more

8 terms

neonatal Fc receptor (FcRn) medical

"Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied..."

Neonatal Fc receptor (FcRn) is a protein in the body that binds and protects certain antibodies from being broken down, effectively acting like a recycling center that extends their lifespan and helps move them between tissues. For investors, FcRn matters because medicines that target or use this receptor can change how long antibody drugs last or reduce harmful antibodies in autoimmune diseases, affecting dosing, effectiveness, safety and commercial value.

immunoglobulin G (IgG) medical

"...designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated..."

Immunoglobulin G (IgG) is the most abundant antibody the body makes to spot and neutralize germs and to remember past infections; think of it as the immune system’s long-term security cameras and memory cards. For investors, IgG matters because tests that measure IgG, medicines built from or mimicking IgG, and engineered IgG therapies are common products in diagnostics, vaccines and biopharma pipelines, influencing clinical results, regulatory decisions and potential revenues.

SLE Responder Index 4 (SRI-4) medical

"met the primary endpoint...as measured by SLE Responder Index 4 (SRI-4)..."

SLE Responder Index 4 (SRI‑4) is a composite clinical measure used in lupus trials that signals meaningful patient improvement by combining three checks: a drop in disease activity of at least four points on a symptom score, no major new organ problems, and no overall worsening by the treating physician. For investors it matters because meeting the SRI‑4 in a clinical trial is often used to demonstrate a drug’s effectiveness, influencing regulatory approval chances and commercial prospects—like clearing key checkpoints on a product’s path to market.

Lupus Low Disease Activity State (LLDAS) medical

"...through 52 weeks...as measured by both SRI-4 and Lupus Low Disease Activity State (LLDAS)."

Lupus low disease activity state (LLDAS) is a recognized treatment goal and clinical trial endpoint for people with systemic lupus erythematosus that describes when the disease is controlled at a low, stable level without major flares or heavy medication use. For investors, LLDAS matters because achieving it in clinical studies signals meaningful patient benefit and can drive regulatory approval, prescribing uptake and the commercial value of therapies—think of it as a measurable ‘good health’ milestone that shows a drug is doing its job.

SELENA-SLE Disease Activity Index (SELENA-SLEDAI) medical

"It comprises criteria from three different internationally validated indices, SELENA-SLE Disease Activity Index (SELENA-SLEDAI)..."

A standardized clinical score that measures how active systemic lupus erythematosus (SLE) is by adding up specific symptoms and test results to produce a single number. Think of it as a medical report card: higher scores mean more disease activity, lower scores mean improvement. Investors watch SELENA-SLEDAI results from drug trials because changes in the score indicate whether a treatment is working, which affects regulatory approval, clinical value and market potential.

Physician Global Assessment (PGA) medical

"...SELENA-SLEDAI), Physician Global Assessment (PGA) and the British Isles Lupus Assessment Group..."

A physician global assessment (PGA) is a doctor’s overall rating of a patient’s illness severity or improvement, usually recorded on a simple numerical or verbal scale after examining symptoms and signs. Think of it as a single summary score a coach gives a player after watching a game: it captures overall performance at a glance. Investors care because PGA scores are often used in clinical trials to show whether a treatment visibly helps patients, which can affect regulatory approval, market acceptance and commercial value.

British Isles Lupus Assessment Group (BILAG) 2004 medical

"...Assessment (PGA) and the British Isles Lupus Assessment Group (BILAG) 2004."

A standardized clinical scoring system used to measure how active lupus (systemic lupus erythematosus) is in different organs and body systems; the 2004 version is an updated format of that tool. Investors care because it is commonly used as an endpoint in drug trials and regulatory evaluations—think of it as a multi-section report card that regulators and doctors use to judge whether a treatment is truly improving patients, which directly affects a therapy’s approval and market potential.

treat-to-target medical

"LLDAS, a key exploratory endpoint that enables a treat-to-target approach..."

A treat-to-target strategy sets a specific health goal—like a lab value or symptom level—and adjusts treatments until that goal is reached and maintained, much like aiming for a set temperature on a thermostat and changing the heater until the room is steady. Investors care because it creates clear, measurable criteria for using a therapy, which can make clinical adoption, prescribing patterns, reimbursement decisions and long-term sales more predictable.

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• Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune function
• Results demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg/kg group^a
• The ongoing Phase 3 study of nipocalimab is currently recruiting people living with systemic lupus erythematosus – a debilitating autoantibody-driven disease which can lead to systemic organ damage

LONDON, June 3, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SLE Responder Index 4 (SRI-4)^b and continued to demonstrate sustained reduction in disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE)^a through 52 weeks in the Phase 2 JASMINE study as measured by both SRI-4^b and Lupus Low Disease Activity State (LLDAS).^c In addition, the study results showed greater response versus placebo plus background medication^d in participants who tested positive for lupus-associated autoantibodies, which represents the vast majority (~80%) of people living with SLE.^e,1 These findings will be featured in a late-breaking presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London and are among the 38 abstracts the Company is presenting across its Rheumatology portfolio. 

Nipocalimab is designed to selectively block the neonatal Fc receptor (FcRn), reducing levels of circulating pathogenic immunoglobulin (IgG) autoantibodies and immune complexes associated with inflammation in SLE.^2,3 By reducing circulating IgG, including autoantibodies, nipocalimab is designed to target the underlying cause of disease while preserving critical immune functions.⁴ JASMINE is the first clinical study to demonstrate efficacy of FcRn blockade in SLE and provides clinical, biomarker and pharmacodynamic evidence supporting the continued investigation of nipocalimab as a potential treatment option for this disease.⁵

A healthcare professional's perspective
"The consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus," said Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell.^f "These 52-week findings support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage."

JASMINE Phase 2 clinical findings
The Phase 2 JASMINE study is the first proof-of-concept for a FcRn-blocker in SLE and demonstrates the potential of nipocalimab to reduce disease activity, with greater responses observed in autoantibody-positive patients.^1,5

• The study met its primary endpoint at Week 24, with a greater proportion of patients receiving nipocalimab 15 mg/kg plus background medication achieving an SRI-4^b response compared with placebo plus background medication (53.5% vs 46.7%). 
• In a predefined autoantibody-positive patient population^e, greater SRI-4 response rates were observed (58.2% vs. 36.1%) and greater achievement of LLDAS (38.9% vs. 18.0%) compared with placebo plus background medication at Week 52.
• At Week 52, a key secondary endpoint, 53.6% of patients receiving nipocalimab 15 mg/kg achieved an SRI-4^b response, compared with 39.7% for placebo plus background medication.
• More patients receiving nipocalimab 15 mg/kg also achieved LLDAS^c, a key exploratory endpoint that enables a treat-to-target^g approach, compared with placebo plus background medication (37.5% vs. 20.5%) at Week 52.

Nipocalimab had a safety profile consistent with previous studies of nipocalimab and no new safety signals were identified. The most common adverse reactions in patients with SLE treated with nipocalimab (≥10%) were nasopharyngitis, headache, urinary tract infection and nausea.⁵

"The JASMINE results provide important new insights into the potential of nipocalimab for adults with moderate-to-severe systemic lupus erythematosus as we continue advancing this program," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "We are especially encouraged by the responses observed in autoantibody-positive study participants. These findings support the potential of nipocalimab as a targeted, immunoselective treatment designed to address underlying drivers of systemic lupus erythematosus." 

Nipocalimab received Fast Track Designation in SLE by the U.S. Food and Drug Administration (FDA) earlier this year. The ongoing Phase 3 GARDENIA study is currently recruiting.

Editor's Notes: 

a. Nipocalimab is not FDA-approved for SLE. 

b. The SRI-4 is a composite measure used to assess treatment response in patients with SLE during clinical studies. It comprises criteria from three different internationally validated indices, SELENA-SLE Disease Activity Index (SELENA-SLEDAI), Physician Global Assessment (PGA) and the British Isles Lupus Assessment Group (BILAG) 2004.

c. LLDAS definition: (1) SLE Disease Activity Index (SLEDAI)-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) ≤1; (4) a current prednisolone (or equivalent) dose ≤7.5 mg daily; and (5) well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. 

d. Protocol-permitted background medications include oral corticosteroids, antimalarials and no more than two of the following immunomodulatory drugs: azathioprine, mycophenolate mofetil, mycophenolic acid, oral methotrexate.

e. The autoantibody-positive population was defined as participants who met ≥1 of the following during screening: (1) positive anti-double-stranded DNA (anti-dsDNA), (2) positive anti-Smith, (3) positive antinuclear antibodies (ANA) and positive for anti-Ro, anti-RNP or had a history of anti-dsDNA.

f. Dr. Richard Furie has provided consulting, advisory and speaking services to Johnson & Johnson. He has not been paid for any media work.

g. Treat-to-target in SLE is a therapeutic strategy in which treatment is guided by regular assessment of disease activity and adjusted to achieve a predefined target – primarily remission, or low disease activity if remission is not attainable – to improve long-term outcomes and prevent organ damage.⁶

ABOUT JASMINE
JASMINE (NCT04882878) is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate nipocalimab in 228 adult participants with active systemic lupus erythematosus (SLE). Adults aged 18-65 years with moderate-to-severe SLE, defined by established measures of disease activity, who were positive for antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA), and/or anti-Smith antibodies, and had not responded to at least one standard-of-care treatment were enrolled. Participants were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through Week 52, in addition to protocol-permitted background medications. The primary endpoint was the SLE Responder Index-4 (SRI-4) composite response at Week 24. Pharmacodynamic effects and safety, including adverse events, were assessed through Week 58.⁵

ABOUT SYSTEMIC LUPUS ERYTHEMATOSUS
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that occurs when the body's immune system mistakenly attacks its own healthy tissues.^7,8 This can lead to inflammation and damage in many parts of the body, including the skin, joints, heart, lungs, kidneys and brain.³ SLE affects nine times more women than men, often striking initially between the ages of 15-44.⁹ 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.³ 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.¹⁰ Severe fatigue is the most widely reported and debilitating symptom of SLE, affecting up to 80% of people with SLE.¹¹ SLE is the most common form of lupus, affecting 3 to 5 million people worldwide, approximately 70% of lupus cases.^12,13 It is estimated that 450,000 people in the United States are affected by SLE.¹⁴

ABOUT NIPOCALIMAB 
Nipocalimab is an investigational immunoselective treatment designed to target, bind with high affinity, and block neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions.^2,3 Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic disease, Rare Autoantibody diseases and Maternal Fetal diseases mediated by maternal alloantibodies in which blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus. ^{5,15,16,17,18,19,20,21,22,23}

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, generalized myasthenia gravis (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 in wAIHA in Q2 2026 

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. 

Janssen Biotech, Inc. is a Johnson & Johnson company.  

Cautions Concerning Forward-Looking Statements 

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. 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 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. 

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¹ Richard A Furie, Ronald van Vollenhoven, Rafał Wojciechowski, Eric Morand, Guillermo J. Pons-Estel, George A Karpouzas, Bart van Hartingsveldt, Robert W Hoffman, Terence Rooney, Sheng Gao, Robert Gordon, Kim Hung Lo, Jocelyn H. Leu, Federico Zazzetti, Stanley J. Marciniak, Steven Leonardo, Keying Ma, Kathy Sivils, Leonard Dragone, Loqmane Seridi, Linda Okonkwo, Erika Noss, Fang Liu-Walsh, Michelle Petri. Nipocalimab in SLE: First-in-class efficacy and safety results demonstrating proof of concept for FcRn blockade from the Phase 2 JASMINE-SLE study. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.
² 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.
³ National Institute of Arthritis and Musculoskeletal and Skin Disease. (2022) Systemic Lupus Erythematosus (Lupus). https://www.niams.nih.gov/health-topics/lupus. Last accessed: April 2026.
⁴ Cossu 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.
⁵ ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026
⁶ Bracalenti M, Iaccarino L, Doria A. Remission and low disease activity in systemic lupus erythematosus. Rare Dis Orphan Drugs J. 2025;4:28. https://dx.doi.org/10.20517/rdodj.2025.10
⁷ Lupus Foundation of America. Understanding Lupus https://www.lupus.org/understanding-lupus. Last accessed: June 2026.
⁸ Kawka L, et al. Fatigue in Systemic Lupus Erythematosus: An Update on Its Impact, Determinants and Therapeutic Management. J Clin Med. 2021 Sep 3;10(17):3996. doi: 10.3390/jcm10173996. PMID: 34501444; PMCID: PMC8432566.
⁹ 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.
¹⁰ Centers for Disease Control and Prevention. (2024). Symptoms of lupus. https://www.cdc.gov/lupus/signs-symptoms/. Last accessed: June 2026.
¹¹ Lupus Foundation of America. Understanding the Invisible Impact of Lupus. Available at: https://www.lupus.org/resources/understanding-the-invisible-impact-of-lupus. Last accessed: June 2026.
¹² 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
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Media contact: Bridget Kimmel BKimmel@ITS.JNJ.com

Investor contact: Jess Margevich Investor-relations@its.jnj.com

 

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SOURCE Johnson & Johnson

FAQ

What did Johnson & Johnson (JNJ) announce about nipocalimab in SLE on June 3, 2026?

Johnson & Johnson announced that nipocalimab met the primary endpoint in the Phase 2 JASMINE study in systemic lupus erythematosus. According to Johnson & Johnson, the drug reduced disease activity at 24 weeks and sustained benefits through 52 weeks, particularly in autoantibody-positive adults.

How effective was nipocalimab in the Phase 2 JASMINE trial for SLE (JNJ)?

Nipocalimab showed higher SRI-4 response rates than placebo at 24 and 52 weeks in JASMINE. According to Johnson & Johnson, 53.5% vs 46.7% achieved SRI-4 at week 24 and 53.6% vs 39.7% at week 52 with nipocalimab 15 mg/kg versus placebo.

What were the results in autoantibody-positive SLE patients treated with nipocalimab (JNJ)?

In predefined autoantibody-positive patients, nipocalimab produced higher response rates than placebo at 52 weeks. According to Johnson & Johnson, SRI-4 responses were 58.2% vs 36.1% and LLDAS achievement was 38.9% vs 18.0% for nipocalimab versus placebo plus background medication.

What safety profile did nipocalimab show in the JASMINE Phase 2 SLE study?

Nipocalimab’s safety profile in JASMINE was consistent with previous studies, with no new safety signals observed. According to Johnson & Johnson, common adverse reactions (≥10%) in SLE patients included nasopharyngitis, headache, urinary tract infection and nausea during treatment.

Is nipocalimab approved for systemic lupus erythematosus and what are the next steps (JNJ)?

Nipocalimab is not yet FDA-approved for systemic lupus erythematosus and remains investigational. According to Johnson & Johnson, it has FDA Fast Track Designation in SLE and is being further studied in the ongoing Phase 3 GARDENIA trial, which is currently recruiting.

What is the SLE Responder Index 4 (SRI-4) used in Johnson & Johnson’s nipocalimab trial?

The SRI-4 is a composite measure to assess treatment response in SLE clinical studies. According to Johnson & Johnson, it combines criteria from SELENA-SLEDAI, Physician Global Assessment and BILAG 2004 indices to quantify changes in disease activity over time.

What is Lupus Low Disease Activity State (LLDAS) and how did nipocalimab affect it in SLE (JNJ)?

LLDAS reflects low disease activity based on strict clinical and treatment criteria in SLE. According to Johnson & Johnson, more patients on nipocalimab 15 mg/kg achieved LLDAS at week 52 than placebo (37.5% vs 20.5%), with higher rates also seen in autoantibody-positive patients.