leflunomide / Generic mfg. - LARVOL DELTA

When the Treatment Mimics the Disease: Methotrexate-Associated Terminal Ileitis (ACG 2026) - "Case Description/ A 68-year-old woman with seropositive RA was transitioned from leflunomide to adalimumab 40 mg every other week for inadequate disease control and was later started on MTX 15 mg weekly for additional disease control. Figure: Image 1. Colonoscopy findings"

Crohn's disease • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Rheumatoid Arthritis • Thrombocytopenia • DHFR

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: NYU Langone Health | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2027 ➔ Jan 2028 | Initiation date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2027 ➔ Jan 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Orthopedics • Psoriatic Arthritis • Rheumatology

Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis after failure of biologic or targeted synthetic therapy: a systematic review and network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "We found high-certainty evidence that nine therapies and moderate-certainty evidence that two therapies provide a clinically important benefit in improving disease activity compared to placebo for people with rheumatoid arthritis after failure of b/ts DMARD therapy. There was significant uncertainty surrounding treatment-related harms, with the evidence having been downgraded for serious or extremely serious imprecision. Pair-wise comparisons showed no significant differences among therapies, although the certainty of evidence was low. The lack of clarity regarding safety and comparative efficacy suggests that treatment decisions should be guided by individual patient characteristics and preferences."

Clinical • Journal • Retrospective data • Review • Fatigue • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Pain • Rheumatoid Arthritis • Rheumatology • IL6

Long-Term Cardiovascular Event Risk with Methotrexate versus Leflunomide in Seronegative Rheumatoid Arthritis: A Real-World Analysis (ACR Convergence 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Cardiovascular • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Risk of Tuberculosis Reactivation in Patients Treated with Leflunomide: A Systematic Review and Meta-Analysis (ACR Convergence 2026) - No abstract available

Retrospective data • Review • Infectious Disease • Respiratory Diseases • Tuberculosis

Seeing an Alternative: The Role of Leflunomide in Autoimmune Eye Disease (ACR Convergence 2026) - No abstract available

Immunology • Ophthalmology

The Sjögren's Tool for Assessing Response (STAR) demonstrates its ability to accurately detect treatment efficacy in 17 recent RCTs in Sjögren's disease (ACR Convergence 2026) - P1/2, P2, P2/3, P3 | " The following data were used to assess the performance of 20 STAR candidate options: Data from 9 clinical trials used for STAR development: abatacept (NCT02915159), leflunomide + hydroxychloroquine (REPURPSS-I, EudraCT 2020-001933-11), rituximab (TEARS NCT0074094, TRACTISS ISRCTN65360827), hydroxychloroquine (JOQUER NCT00632866), tocilizumab (NCT01782235), baminercept (NCT01552681), and phase II trials of iscalimab (NCT02291029) and ianalumab (NCT02962895). Data from 7 independent clinical trial datasets (external validation set): belimumab ± rituximab (NCT02631538), abatacept (NCT02915159), anti-IL-7 therapy (NCT04605978), remibrutinib (NCT04035668), iscalimab (NCT03905525, cohorts 1 and 2), leflunomide + hydroxychloroquine (EudraCT 2020-001933-11), and dazodalibep (NCT04129164)... This large number of new trials provided a large amount of data for informing the selection of the final STAR responder index. The STAR 3AV1 where response rely on..."

Clinical • Sjogren's Syndrome • IL7

Early Post-Vaccination Antibody Levels, One-year Follow-up and Breakthrough Herpes Zoster After Recombinant Zoster Vaccination in a Large Autoimmune Rheumatic Diseases Cohort (ACR Convergence 2026) - "Among ARD patients, older age (p< 0.001), female sex (p=0.015), prednisone ≥ 7.5mg/day (p=0.004), combined therapy (p=0.032), methotrexate (p=0.043), and rituximab (p< 0.001) were associated to reduced antibody levels at T12M, while black ethnicity (p< 0.001) and leflunomide (p< 0.001) were associated to higher titers at T12M (Figure 2). In this large prospective ARD cohort, antibody levels after RZV waned over 12 months in both ARD patients and controls and remained significantly lower among ARD patients. Despite lower antibody levels, post-vaccination HZ incidence was similar to controls. Importantly, lower early post-vaccination antibody titers at 3 months, together with prednisone exposure, were associated with breakthrough HZ, suggesting that early antibody response may help to identify vaccinated ARD patients who warrant closer follow-up."

Herpes Zoster • Immunology • Rheumatology • Varicella Zoster

Leflunomide Exposure Duration and Dose Are Not Associated with Incident or Progressive Interstitial Lung Disease in Rheumatoid Arthritis: A Longitudinal CT Study (ACR Convergence 2026) - No abstract available

Longitudinal study • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Pyrimidine Metabolism Drives Cystic Fibrosis Lung Disease (NACFC 2026) - "DNPPS was inhibited using siRNA targeting DHODH (DNPPS rate-limiting enzyme) and pharmacological inhibitors (leflunomide, teriflunomide, brequinar, and gemcitabine). CFTR correction was achieved using elexacaftor/tezacaftor/ivacaftor (ETI)... We show that airway remodeling and P. aeruginosa infection in the CF lung are tightly linked via altered pyrimidine signaling, a metabolic configuration promoted by CFTR mutations and mitochondrial impairment. We also reveal that this adverse environment is correctable, opening new therapeutic targets to improve CF patients' health."

Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • CFTR

Presence of Antinuclear Antibodies in the Cerebrospinal Fluid and in the Serum in a Patient With Sjögren's Syndrome and Systemic Lupus: A Case Report. (PubMed, Case Reports Immunol) - "Hydroxychloroquine (HCQ) had been discontinued 4 months prior due to HCQ-related optic neuropathy confirmed on optical coherence tomography (OCT)...The patient received intravenous methylprednisolone (500 mg/day × 3 days) followed by oral corticosteroids, with leflunomide added as an immunomodulatory agent given the overlap syndrome context, resulting in a favourable clinical outcome. The absence of intrathecal immunoglobulin synthesis and oligoclonal bands supports blood-brain barrier dysfunction rather than a primary demyelinating process, highlighting the diagnostic challenge in SLE-SS overlap. ANA detection in CSF may serve as a supportive marker for neuropsychiatric lupus (NPSLE) in overlap syndromes."

Journal • Bronchiectasis • Immunology • Inflammatory Arthritis • Lupus • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Psychiatry • Pulmonary Disease • Respiratory Diseases • Sjogren's Syndrome • Systemic Lupus Erythematosus

A Rare Case of Hemophagocytic Lymphohistiocytosis in an Older Adult With Multi-Organ Failure Leading to Heart Failure With Preserved Ejection Fraction (SOHO 2026) - "Case Presentation: A 59-year-old man with hypertension and rheumatoid arthritis on chronic leflunomide therapy presented with fever, tachycardia, and syncope after a recent dental procedure complicated by suspected bacteremia...High-dose corticosteroids and etoposide were initiated for presumed secondary HLH triggered by infection... This case highlights the importance of considering HLH in adults with persistent systemic inflammation and cytopenias unresponsive to standard infection management. Prompt diagnosis and initiation of HLH-directed therapy are critical to reducing morbidity and mortality."

Clinical • Oncology

Beyond the Prevention of Anti-drug Antibody Formation with Uricase Therapy: Mechanistic Roles of DMARDs in Modifying Gout Flare Risk. (PubMed, BioDrugs) - "In this hypothesis-generating narrative review, we have synthesized mechanistic data investigating the effects of the DMARDs methotrexate, mycophenolate mofetil, azathioprine, leflunomide, and sirolimus on mechanisms involved in gout flare such as NACHT, LRR, and PYD domain-containing protein 3 (NLRP3) inflammasome activation. Therefore, the inflammatory consequences of combining DMARDs with uricase therapy are likely to be specific to the individual agent. Understanding the mechanistic profile of each DMARD is key to optimizing both immunogenicity management and flare outcomes in patients receiving uricase therapy for uncontrolled gout."

Journal • Review • Gout • Inflammatory Arthritis • Rheumatology • NLRP3

Predictors of intramuscular glucocorticoid bridge therapy failure in rheumatoid arthritis: a real-world observational study. (PubMed, Ther Adv Musculoskelet Dis) - "High disease activity and concurrent leflunomide use at GCs initiation independently predict failure of intramuscular GCs bridge therapy in RA. Early risk stratification may optimize induction therapy selection and potentially improve bridge therapy success rates."

Journal • Observational data • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Retrospective evaluation of outcomes in dogs with non-associative immune-mediated haemolytic anaemia treated with rivaroxaban as a sole or adjunctive thromboprophylaxis agent: 34 cases (2018-2024). (PubMed, J Small Anim Pract) - "This represents one of the largest UK-based cohorts of dogs with non-associative immune-mediated haemolytic anaemia treated with rivaroxaban, demonstrating acceptable survival and remission rates with this thromboprophylaxis protocol. The occurrence of clinically significant gastrointestinal bleeding exclusively in dogs receiving concurrent corticosteroids, mycophenolate mofetil and rivaroxaban represents an important safety signal that warrants consideration and further study."

Journal • Retrospective data • Anemia • Cardiovascular • Gastroenterology • Hematological Disorders

ACUTE WORSENING OF RHEUMATOID ARTHRITIS-ASSOCIATED INTERSTITIAL LUNG DISEASE: A DIAGNOSTIC DILEMMA INCLUDING POSSIBLE LEFLUNOMIDE-ASSOCIATED LUNG INJURY (CHEST 2026) - No abstract available

Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

The Effect of Nicorandil on Rheumatoid Arthritis Patients (clinicaltrials.gov) - P2/3 | N=70 | Recruiting | Sponsor: Ain Shams University | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Rheumatoid Pleuropulmonary Disease Mimicking Refractory Empyema: A Diagnostic Challenge With Trapped Lung. (PubMed, Cureus) - "Because the lung remained trapped by a fibrous peel, staged thoracotomy with decortication and parietal pleurectomy was performed, and immunosuppression was escalated from leflunomide to rituximab. This case illustrates that in a patient with established RA, an exudative, culture-negative, purulent-appearing pleural effusion should raise suspicion of rheumatoid pleuritis before empyema. Early recognition, alongside continued exclusion of infection, may reduce diagnostic delay and the need for extensive thoracic surgery."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Rheumatoid Arthritis in Adults: A Review. (PubMed, JAMA) - "The European Alliance of Associations for Rheumatology recommends starting treatment with methotrexate, 7.5 mg to 10 mg orally weekly, increasing to 20 mg to 25 mg weekly within 4 to 8 weeks, and considering addition of short-term glucocorticoids (eg, prednisone, 5-7.5 mg/d), tapered and discontinued within 3 months, or 1 intramuscular injection of 80 mg to 160 mg depot methylprednisolone. For patients with contraindications to methotrexate, sulfasalazine (2-4 g/d) or leflunomide (20 mg/d) is recommended...First-line initial therapy is methotrexate, with consideration of glucocorticoids as additive therapy. For patients who do not achieve remission with this initial treatment, adding biological DMARDs or JAK inhibitors increases overall remission or low disease activity rates to 80%."

Journal • Cardiovascular • Immunology • Inflammatory Arthritis • Oncology • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Vasculitis • CRP

Leflunomide-Induced Severe Cutaneous Adverse Reaction, Severe Drug-Induced Liver Injury With Hepatic Encephalopathy, and Hemophagocytic Lymphohistiocytosis: A Case Report. (PubMed, Cureus) - "This case not only exemplifies the potential severe complications associated with leflunomide but also illustrates the life-saving potential of early diagnosis and treatment in cases of drug-induced HLH and DRESS syndrome. This case contributes to the literature by underscoring the complexities of managing rare but severe side effects of commonly used medications."

Journal • CNS Disorders • Eosinophilia • Hemophagocytic lymphohistiocytosis • Hepatic Encephalopathy • Hepatology • Immunology • Inflammatory Arthritis • Liver Failure • Rare Diseases • Rheumatoid Arthritis • Rheumatology

Weight change patterns in rheumatoid arthritis patients treated with leflunomide: A real-world comparative study. (PubMed, Reumatol Clin (Engl Ed)) - "Leflunomide is independently associated with clinically meaningful and often progressive weight loss in patients with RA. These findings support routine weight monitoring in leflunomide-treated patients and underscore the importance of distinguishing drug-related weight reduction from other causes to avoid unnecessary diagnostic investigations and optimise patient counselling."

Clinical • Journal • Observational data • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Characterizing Regional Variation of PFAS Profiles in Human Serum from China by Integrated Target and Nontarget Analysis with Machine Learning. (PubMed, Environ Sci Technol) - "Nontarget analysis identified 49 PFASs, among which bis(trifluoromethane)sulfonimide (Ntf2), C8 per- and polyfluoroalkyl ether carboxylic acid, C12 hydrogen-substituted polyfluoroalkyl (linear) carboxylic acid, 8:2 fluorotelomer unsaturated carboxylic acid, 1-hydroxy-6:2 fluorotelomer sulfonic acid, haloxyfop, and leflunomide were reported in human serum for the first time...Furthermore, PFNA, Ntf2, PFOA, and 6:2 Cl-PFESA were identified as distinctive exposure biomarkers for SX, GD, HeB, and HuB, respectively, each being closely associated with local industrial activities. Overall, this study elucidates the region-specific characteristics of human PFAS exposure in China, providing a scientific basis for regionally tailored health risk assessment and pollution control strategies."

Journal

Impact of renal function on the safety of biologic and synthetic DMARDs in rheumatoid arthritis: A retrospective cohort study from a Turkish tertiary center. (PubMed, Medicine (Baltimore)) - "Use of nephrotoxic csDMARDs (methotrexate, leflunomide) and nonsteroidal anti-inflammatory drugs (NSAIDs) decreased with advancing CKD, whereas glucocorticoid use increased. In multivariable analysis, younger age, longer RA disease duration, higher baseline estimated glomerular filtration rate, and higher baseline Disease Activity Score 28-erythrocyte sedimentation rate were independently associated with the occurrence of any adverse event. While csDMARD and NSAID toxicity increase progressively with renal impairment, biologic and targeted synthetic agents maintain a stable safety profile across CKD stages."

Journal • Retrospective data • Cardiovascular • Chronic Kidney Disease • Diabetes • Hypertension • Immunology • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Renal Disease • Rheumatoid Arthritis • Rheumatology

Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study. (PubMed, Health Technol Assess) - P | "There was high-quality evidence for elevated liver enzymes and folate non-supplementation being prognostic for methotrexate hepatotoxicity, mercaptopurine being prognostic for thiopurine hepatotoxicity and myelotoxicity; poor thiopurine metabolizer being prognostic for cytopenia; and elevated liver enzymes being prognostic for hepatotoxicity due to anti-tumour necrosis factor-alpha...The calibration slope (95% confidence interval) in validation cohort was 0.94 (0.85 to 1.02) for methotrexate, 1.10 (0.84 to 1.36) for thiopurines, 0.91 (0.74 to 1.07) for leflunomide, 1.19 (0.96 to 1.43) for sulfasalazine, and 0.90 (0.61 to 1.19) for 5-aminosalicylates...64. See the NIHR Funding and Awards website for further award information."

Journal • Hematological Disorders • Oncology

Concurrent Caudal Occipital Malformation Syndrome-Associated Syringomyelia and Presumptive Meningoencephalomyelitis of Unknown Origin Managed with Combined Surgical Decompression and Immunosuppressive Therapy in a Dog. (PubMed, Vet Sci) - "Combined surgical decompression and immunosuppressive therapy using leflunomide and mycophenolate mofetil were subsequently initiated. This case highlights the importance of repeat MRI evaluation in neurologic patients exhibiting progressive deterioration despite previous treatment, even when an established structural diagnosis is present. Recognition of MRI findings suggestive of concurrent inflammatory disease may substantially influence diagnostic interpretation and therapeutic decision-making in selected patients."

Journal • CNS Disorders • Inflammation • Ventriculomegaly