Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab - LARVOL DELTA

Bilateral acute retinal necrosis after ofatumumab masquerading as intermediate uveitis in a patient with multiple sclerosis. (PubMed, Am J Ophthalmol Case Rep) - "A 47-year-old female with multiple sclerosis was transitioned to ofatumumab (Arzerra/Kesimpta, Novartis, Cambridge, MA, USA) for better systemic control of her disease...This is a unique case of bilateral ARN after starting ofatumumab medication for multiple sclerosis. This case also highlights the importance of discerning between intermediate uveitis associated with multiple sclerosis and infectious uveitis in the setting of immunocompromise."

Journal • CNS Disorders • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Disease outcomes following lateral switch among different CD20-antibodies in active multiple sclerosis. (PubMed, Mult Scler) - "Lateral switching between BCT does not abate effectiveness in this matched real-world cohort. Our observation of increased loss of IgG warrants further validation, but may indicate niche-specific immunological effects of OFA and OCR."

Journal • CNS Disorders • Multiple Sclerosis

Real-world change in annualized relapse rate and healthcare resource utilization following initiation of ofatumumab in people with multiple sclerosis. (PubMed, Mult Scler Relat Disord) - "In a real-world sample of people with MS, ARR was reduced by 75 % following initiation of OMB. MS-related hospitalization, days of hospitalization, and OP visits also decreased significantly following OMB initiation. Results align with clinical trial evidence of OMB's efficacy in reducing relapse incidence in MS and suggest these benefits translate to reduced HCRU."

HEOR • Journal • Real-world evidence • CNS Disorders • Multiple Sclerosis • CD20

Novartis reports strong Q2 with double-digit sales growth and core margin expansion; raises FY 2025 core operating income guidance (Novartis Press Release) - "Q2 net sales grew +11% (cc, +12% USD) with core operating income up +21% (cc, +20% USD); Sales growth driven by continued strong performance from Kisqali (+64% cc), Entresto (+22% cc), Kesimpta (+33% cc), Scemblix (+79% cc), Leqvio (+61% cc) and Pluvicto (+30% cc); Core operating income margin reached 42.2%, +340 basis points (cc), mainly driven by higher net sales"

Commercial • Atherosclerosis • Castration-Resistant Prostate Cancer • Chronic Myeloid Leukemia • Dyslipidemia • Heart Failure • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Hormone Sensitive Prostate Cancer • Multiple Sclerosis

Case Report: Subcutaneous ofatumumab for patients with immunosuppressant-dependent or ineffective primary membranous nephropathy. (PubMed, Front Immunol) - "CD20 monoclonal antibodies (mAbs), particularly rituximab, have become a preferred treatment for many patients with phospholipase A2 receptor (PLA2R)-related membranous nephropathy (MN). No adverse reactions were reported during the observation period. In conclusion, this study highlights the efficacy and safety of subcutaneous ofatumumab in treating PMN, particularly in patients who have failed or relapsed after conventional therapies."

Journal • CNS Disorders • Glomerulonephritis • Multiple Sclerosis • Renal Disease

Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis. (PubMed, Neurol Ther) - P3 | "Ofatumumab has a favourable benefit-risk profile that is sustained up to 5 years."

Journal • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Oncology

WOE of Anti-CD20 Therapies (clinicaltrials.gov) - P=N/A | N=150 | Completed | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Delphi panel to understand the real-world occurrence and management of ofatumumab injection-related reactions among healthcare providers of people with relapsing multiple sclerosis. (PubMed, Mult Scler J Exp Transl Clin) - "Pre-/post-treatment of systemic IRRs was not uniformly required. This study gives health care providers insight into the potential occurrence and management of IRRs with ofatumumab in the clinical practice setting."

Journal • Real-world evidence • CNS Disorders • Multiple Sclerosis

Exacerbation of Psoriasis During Treatment With Ofatumumab for Multiple Sclerosis. (PubMed, J Dermatol) - No abstract available

Journal • CNS Disorders • Dermatology • Immunology • Multiple Sclerosis • Psoriasis

Neutropenia Associated With B Cell-Depleting Therapies in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "This study is comprehensive and reflects a large cohort, examining incidence rates of neutropenia with BCDT in MS and NMOSD. Overall, neutropenia was still rare, occurring at a rate of 0.66 per 100 person-years, and infections were associated triggers in some patients. Yet, of relevance to clinicians, neutropenia was not benign: half required hospitalization and 35% experienced recurrence, which is higher than what was reported in clinical trials."

Journal • Retrospective data • CNS Disorders • Hematological Disorders • Infectious Disease • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Neutropenia • Rare Diseases

Effectiveness of anti-CD20 therapies following natalizumab discontinuation: insights from a cohort study. (PubMed, Mult Scler Relat Disord) - "Anti-CD20 therapies appear to be a safe option after NTZ discontinuation, with no rebound disease and stable EDSS. PIRA was the main driver for disability progression, emphasizing the need to control smoldering disease."

Journal • CNS Disorders • Multiple Sclerosis • Rare Diseases

Real-life experience with the second-generation anti-CD20 antibodies for treatment of immune-mediated glomerular diseases (ERA 2025) - "The indications for the new anti-CD20 therapy were: 4 (66%) for refractory disease, 1 (16.7%) for recurrent flares, and 1 (16.7%) due to an anaphylactic reaction to rituximab. The new anti-CD20 therapies used were: obinutuzumab in 4 (66%) patients and ofatumumab in 2 (33%)... The use of new anti-CD20 therapies for the treatment of immune-mediated glomerular diseases appears to be more effective than Rtx in inducing remission of glomerulopathy in refractory cases. New anti-CD120 achieved CD19 depletion in all cases and with an adequate safety profile. Further research and clinical trials should be conducted to confirm these positive results."

Clinical • Chronic Kidney Disease • Complement-mediated Rare Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Lupus Nephritis • Nephrology • Renal Disease

Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab (clinicaltrials.gov) - P=N/A | N=75 | Enrolling by invitation | Sponsor: Johns Hopkins University | Trial completion date: Jun 2025 ➔ Mar 2027 | Trial primary completion date: Jun 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis • Ophthalmology

The Italian Multiple Sclerosis Register Experience With Cladribine: Impact on Relapses, PIRA, and Treatment Sequencing Strategies Evaluation. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "For patients with RMS, both naïve and switchers, as well as younger and older patients, cladribine is an effective treatment in reducing relapses and PIRA. Different therapeutic strategies after cladribine are currently reported."

Journal • Retrospective data • CNS Disorders • Multiple Sclerosis

A disproportionality analysis of nervous system adverse events associated with disease-modifying therapies in multiple sclerosis: insights from the FDA adverse event reporting system (FAERS). (PubMed, J Neurol) - "This study highlights significant differences in the nervous system AEs profiles of DMTs, with SI, NA, FI, and TE showing higher risks of nervous system AEs. These findings underscore the importance of vigilant monitoring and personalized treatment strategies to mitigate nervous system risks in MS patients. Further research is needed to confirm these associations and investigate the mechanisms that underlie them."

Adverse events • Journal • CNS Disorders • Cognitive Disorders • Developmental Disorders • Multiple Sclerosis

Alvotech and Advanz Pharma Extend Strategic Partnership to Commercialize Three Additional Biosimilars in Europe (GlobeNewswire) - "Alvotech...and Advanz Pharm...announced that the companies have entered into an agreement to expand their commercial partnership to cover three additional biosimilar candidates...The new agreement covers the supply and commercialization in Europe of biosimilar candidates to Ilaris (canakinumab), a human antibody interleukin-1β blocker indicated for the treatment of various inflammatory diseases, and Kesimpta (ofatumumab), a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis, in addition to a third undisclosed biosimilar candidate. Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for registration and commercialization in Europe. The agreement includes development and commercial milestones for the three products, totaling up to US$180 million at current exchange rates (EUR 160 million). In addition, the partners will participate in a revenue share."

Licensing / partnership • Immunology • Inflammation • Multiple Sclerosis

MS-PEKOS: Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2025 ➔ Aug 2025 | Trial primary completion date: Jan 2025 ➔ Aug 2025

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Ofatumumab Associated Legionella Pneumonia in a Young Multiple Sclerosis Patient (ATS 2025) - "Treatment with ceftriaxone and azithromycin was initiated. Overnight, he developed a high fever to 40.3 Celsius and treatment was broadened to piperacillin-tazobactam...He was treated with levofloxacin for a five-day course with improvement and discharged breathing room air...While some biologics are associated with Legionellosis such as alemtuzumab, this is less common among anti-CD20 therapies like rituximab...Serogroup 1 accounts for 50 to 80 % of Legionella infections and 8% of patients with Legionnaire's disease excrete no antigen in their urine. This first report demonstrates that in patients immunosuppressed with anti-CD20 therapies presenting with pneumonia, Legionellosis must be considered until definitively ruled out by bronchoscopy, even when urine antigen testing is negative."

Clinical • CNS Disorders • Cough • Infectious Disease • Multiple Sclerosis • Musculoskeletal Pain • Pain • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Real-world observational study of infections in people treated with ocrelizumab for multiple sclerosis. (PubMed, J Neurol) - "Real-world observational studies complement open label extensions of clinical trials, often by having a more representative cohort and more complete follow-up. Our data suggest that while serious infections are rare in people on ocrelizumab, non-serious infections become increasingly burdensome. We offer practical suggestions on mitigating the risk of infection on ocrelizumab and other anti-CD20 medications."

Journal • Observational data • Real-world evidence • CNS Disorders • Infectious Disease • Influenza • Multiple Sclerosis • Respiratory Diseases

Cost-Effectiveness of Ofatumumab for the Management of Multiple Sclerosis from the Perspective of Saudi Healthcare Payers: A 10-Year Markov Cohort Study (ISPOR 2025) - "Compared to teriflunomide, ofatumumab is more cost-effective for the management of RRMS from the perspective of Saudi payers. Additional research should investigate the long-term cost-effectiveness of ofatumumab for a period exceeding ten years."

Cost effectiveness • HEOR • CNS Disorders • Multiple Sclerosis

Seronegative spondyloarthritis as a complication of anti-CD20 monoclonal antibody treatment in multiple sclerosis. (PubMed, Mult Scler Relat Disord) - "There is a significant association between anti-CD20 mAb treatment and SpA in people with MS. The incidence of SpA in this group is over nine times greater than the highest estimates for the general population. MS patients may be at greater risk of this autoimmune complication due to overlap in genetic risk. More research is required to determine optimal treatment strategies, with anti-IL17A mAbs of particular interest given their safety, and potential benefit, in MS."

Journal • Ankylosing Spondylitis • CNS Disorders • Immunology • Multiple Sclerosis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Financial Performance First Quarter of 2025 (GlobeNewswire) - "Revenue was $715 million for the first three months of 2025 compared to $603 million for the first three months of 2024. The increase of $112 million, or 19%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and EPKINLY net product sales; Royalty revenue was $589 million in the first three months of 2025 compared to $452 million in the first three months of 2024, an increase of $137 million, or 30%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta; Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.) by J&J were $3,237 million in the first three months of 2025 compared to $2,692 million in the first three months of 2024, an increase of $545 million or 20%."

Sales • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • High-grade B-cell lymphoma • Indolent Lymphoma • Multiple Myeloma • Multiple Sclerosis • Non-Hodgkin’s Lymphoma

A study of 10 cases of atypical multiple sclerosis treated with ofatumumab (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Multiple Sclerosis

A study on the changes in serum immunoglobulin concentrations in patients with multiple sclerosis after administration of ofatumumab (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Multiple Sclerosis

Three cases of multiple sclerosis presenting with palmoplantar pustulosis while receiving ofatumumab (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Immunology • Multiple Sclerosis • Psoriasis