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

The influence of anti-CD20-directed B cell depletion across different agents on Epstein-Barr virus-specific humoral and cellular immunity in patients with multiple sclerosis. (PubMed, J Neuroinflammation) - "Unlike in treatment-naïve pwMS, BCDT is associated with selectively lower EBV-specific T-cell frequencies while EBV-specific and polyclonal T-cell functionality was largely preserved. In contrast, EBV-specific antibody levels were persistently higher despite treatment. Given the remarkably high clinical efficacy of BCDT in this cohort, the findings support a prominent role of EBV-specific cellular immunity in ongoing MS pathophysiology and suggest that reduced EBV-reactive T-cell responses may contribute to this potency. Differences between BCDT agents warrant further investigation."

Journal • CNS Disorders • Epstein-Barr Virus Infections • Multiple Sclerosis • CD4 • CD8 • IFNG • IL2

Anti-CD20 monoclonal antibody therapies in relapsing multiple sclerosis: A systematic review and meta-analysis of randomised controlled trials. (PubMed, Mult Scler Relat Disord) - "Anti-CD20 mAbs confer consistent, clinically meaningful reductions in relapse rate and MRI disease activity. In the only direct head-to-head RCT, rituximab was non-inferior to ocrelizumab for MRI disease activity in newly diagnosed relapsing MS. Heterogeneity for MRI outcomes is strongly associated with trial design and warrants cautious interpretation; with few trials per stratum this attribution is associative rather than definitive. These agents represent a high-efficacy treatment class for relapsing MS."

Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

TREAT-MS: Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (clinicaltrials.gov) - P=N/A | N=900 | Completed | Sponsor: Johns Hopkins University | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Combining Pembrolizumab and Ofatumumab in Triple-Negative Breast Cancer and Multiple Sclerosis: A Case Report. (PubMed, Surg Case Rep) - "This case demonstrates that pembrolizumab can be safely administered for triple-negative breast cancer in a patient receiving ofatumumab for MS, achieving a pathologic complete response."

Journal • Breast Cancer • CNS Disorders • Multiple Sclerosis • Oncology • Solid Tumor • Triple Negative Breast Cancer

Real-World Outcomes of Ocrelizumab and Ofatumumab Treatment in Pediatric-Onset Multiple Sclerosis. (PubMed, Paediatr Drugs) - "These results provide descriptive real-word data on the use of ocrelizumab and ofatumumab, especially when used as a first-line DMT in pediatric-onset multiple sclerosis. Although limited by a short follow-up period, our real-world findings provide safety and effectiveness data to inform DMT selection and shared decision making with families."

Journal • Real-world evidence • CNS Disorders • Infectious Disease • Multiple Sclerosis • Pediatrics

Spillover Effects of Medical Innovations: A Universal and Scalable Approach to Measure the Societal Value of Avoided Informal Care Time. (PubMed, Appl Health Econ Health Policy) - "The method incorporates the caregiver perspective into economic evaluations by linking patient utility gains to changes in caregiving demand and their societal consequences. The framework provides a transparent and transferable approximation for estimating caregiver productivity spillovers when direct caregiver data are unavailable."

Journal • CNS Disorders • Multiple Sclerosis

Predictors of high- versus low-intensity first-line multiple sclerosis treatments. (PubMed, Mult Scler J Exp Transl Clin) - "The first DMT filled was classified as either high- (natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine) or low-intensity (interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, diroximel fumarate, fingolimod, ponesimod, siponimod, ozanimod)...The minority of MS patients initiated high-intensity treatment although this proportion increased over time, and later years were predictive of high-intensity treatment. Providers had a significant role in the approach selected."

Journal • CNS Disorders • Multiple Sclerosis

Early switching to ofatumumab avoids a rebound effect after natalizumab cessation in multiple sclerosis patients. (PubMed, Mult Scler J Exp Transl Clin) - "After a mean follow-up of 2.4 years (range: 6 months to 4 years), none of the patients had experienced any clinical relapse or magnetic resonance imaging reactivation. We confirm that ofatumumab is likely an effective option, using a short washout period following natalizumab discontinuation."

Journal • CNS Disorders • Multiple Sclerosis

Ofatumumab in multiple sclerosis: 2-year immune profiling and clinical correlates. (PubMed, J Neurol) - "In this exploratory, descriptive, real-world cohort, ofatumumab was associated with sustained B-cell depletion (CD19+/CD20 +) and parallel increases in broad T-cell compartments. No associations with clinical or MRI outcomes were detected; these negative findings should be interpreted cautiously within the hypothesis-generating design, given the small sample size and low frequency of disease-activity events."

Journal • Observational data • CNS Disorders • Multiple Sclerosis • CD27 • CD4 • CD8 • NCAM1

Ocrelizumab versus ofatumumab efficacy and safety after natalizumab discontinuation in multiple sclerosis: a retrospective real-world comparison. (PubMed, J Neurol) - No abstract available

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

Pregnancy Exposure to Anti-CD20 Monoclonal Antibodies in Patients With Multiple Sclerosis: Results From an Italian Multicenter Registry Study. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "In conclusion, a good control of disease activity was observed without an increased risk of MCA or perinatal infections. Percentages of SA were overall in line with those of general population, although with a higher proportion in the "exposed" group. These findings support the use of anti-CD20 therapies in wwMS planning pregnancy, although further data are needed to better define their safety profile in this setting."

Journal • Observational data • CNS Disorders • Infectious Disease • Multiple Sclerosis

A Study Comparing Effectiveness of Kesimpta (Ofatumumab) Versus Ocrevus (Ocrelizumab) in Real-world Practice (clinicaltrials.gov) - P=N/A | N=7466 | Recruiting | Sponsor: Novartis Pharmaceuticals

HEOR • New trial • Real-world evidence • CNS Disorders • Multiple Sclerosis

Ofatumumab Treatment for Refractory Generalized Myasthenia Gravis Post-Lung Adenocarcinoma Resection: A Case Report and Mechanistic Insight. (PubMed, Immun Inflamm Dis) - "This case highlights ofatumumab's potential efficacy and safety in managing refractory gMG post-cancer resection, possibly via robust B-cell depletion and reduced immunogenicity. These findings advocate for targeted B-cell therapies as a viable strategy in complex, refractory MG cases, particularly where conventional immunosuppressants pose oncological concerns."

Journal • CNS Disorders • Immunology • Lung Adenocarcinoma • Lung Cancer • Myasthenia Gravis • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Establishing humoral immunity to rabies in a person with multiple sclerosis through booster vaccination: A case report. (PubMed, Mult Scler J Exp Transl Clin) - "Despite completing the standard rabies vaccination series per the World Health Organization recommendations, he did not establish humoral immunity until he received two additional booster vaccinations. This case highlights novel aspects of humoral immunity to rabies in a person taking ofatumumab."

Journal • CNS Disorders • Multiple Sclerosis

Continuous ofatumumab treatment until the early third trimester in multiple sclerosis with preserved neonatal immunity. (PubMed, Mult Scler J Exp Transl Clin) - "Although neonatal immune status at birth was unavailable, her infant showed normal B-cell counts during follow-up and completed routine vaccinations, including live vaccines, without complications. This case provides clinically relevant longitudinal neonatal immune and vaccination data following late-gestation ofatumumab exposure."

Journal • CNS Disorders • Multiple Sclerosis

Comparative effectiveness of ofatumumab and ocrelizumab in relapsing multiple sclerosis: a target trial emulation using multinational registry data. (PubMed, J Neurol Neurosurg Psychiatry) - "Both therapies were highly effective in a large cohort of patients with RRMS, with very low relapse or CDP rates. Ofatumumab was associated with slightly greater disability control, while ocrelizumab more effectively suppressed relapses. These differences were modest, and their clinical relevance requires further evidence and should be interpreted with caution."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

A Case of Crohn's Disease Requiring Surgical Resection During Treatment with Ofatumumab for Multiple Sclerosis (AOCC-IMKASID 2026) - "Background / Aim: Anti-CD20 antibodies, such as rituximab, have been reported to increase the risk of developing inflammatory bowel disease (IBD)... Although only one case of OFA-associated CD has been previously reported, this case highlights the potential association between anti-CD20 therapy and the development of CD requiring surgical intervention. Clinicians should be aware of this rare but important complication during OFA treatment. Keywords: Crohn's Disease, Anti-CD20, Ustekinumab"

Clinical • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Ulcerative Colitis

Genmab Announces Financial Results for the First Half of 2026 (GlobeNewswire) - "Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX and Kesimpta royalties and higher EPKINLY net product sales....Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%. Global net sales of EPKINLY/TEPKINLY were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%."

Commercial • Sales • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Multiple Myeloma • Multiple Sclerosis

Real-world adherence to and persistence with ofatumumab, infusion, oral, and other self-injectable disease-modifying therapies in patients with multiple sclerosis. (PubMed, Mult Scler J Exp Transl Clin) - "Similar patterns were observed for persistence between the groups. These findings suggest OMB is a convenient, effective, self-administered alternative to infusion therapies."

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

Possible Contribution of Multiple Sclerosis Pathology to Treatment-Resistant Schizophrenia: A Case Study. (PubMed, Neuropsychopharmacol Rep) - "Owing to persistent psychiatric symptoms, clozapine was administered, which showed partial effectiveness...In addition, postmortem studies, including our previous and current observations, provide hypothesis-generating support for partially overlapping MS-like changes in some patients with schizophrenia. Clinicians should consider the possibility of comorbid MS in patients with treatment-resistant schizophrenia, particularly when atypical clinical or neurological features are present."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Multiple Sclerosis • Psychiatry • Schizophrenia

B-cell repopulation and postpartum MS disease activity following ofatumumab cessation for pregnancy in women with multiple sclerosis. (PubMed, Mult Scler) - "B-cell depletion persisted into the third trimester following ofatumumab cessation for pregnancy with low postpartum MS activity, although limited by small sample."

Journal • CNS Disorders • Multiple Sclerosis

Individualized repetitive intravenous immunoglobulin therapy for a 79-year-old patient with GlyR antibody-positive PERM: a case report and literature review. (PubMed, Front Immunol) - "The patient received three sequential courses of IVIg; in addition, a single 20-mg subcutaneous dose of ofatumumab was administered as individualized off-label sequential/salvage immunotherapy...These findings also suggest that repeated IVIg courses may represent a feasible salvage strategy when conventional immunotherapies are limited, but the independent therapeutic contribution of ofatumumab remains uncertain. Serial GlyR1 antibody titers may be useful for monitoring the treatment response, although this result requires confirmation in larger studies."

Journal • Review • CNS Disorders • Critical care • Immunology • Infectious Disease • Movement Disorders • Respiratory Diseases • GLYR1

Treatment Outcomes of Advanced Combination Therapy in Multiple Sclerosis-Inflammatory Bowel Disease Overlap: Single-centre study. (CNSF 2026) - "MS DMTs were ofatumumab (n=5), cladribine (n=3), siponimod (n=1)...Outcomes included IBD remission with MS clinical/radiologic stability in seven patients, a Crohn's flare on fingolimod resolving after switch to cladribine (n=1), and concurrent MS and Crohn's flares five years post-cladribine requiring dual immunotherapy initiation (n=1). Two patients had simple infections.ConclusionsUp to three quarter of patients achieved MS-IBD stability with newer DMTs, either as monotherapy or dual therapy, underscoring the feasibility of individualized, multidisciplinary care in this rare overlap population."

Clinical • Combination therapy • Metastases • CNS Disorders

Anti-CD20 Therapies in Pediatric Acquired Demyelinating Syndromes: Evidence Across MS, AQP4-IgG-Positive NMOSD and MOGAD. (PubMed, CNS Drugs) - "Ocrelizumab has the most advanced pediatric evidence among approved anti-CD20 agents, including dose-selection data from OPERETTA I and comparative Phase 3 data from OPERETTA II, where it reduced MRI activity compared with fingolimod and showed sustained B-cell depletion...Upcoming trials of ofatumumab, ublituximab, and rituximab-based strategies in MOGAD will be critical to refine pediatric dosing, define biomarkers of treatment durability, and establish age-specific safety surveillance for the developing immune system. This review summarizes knowledge on B-cell maturation in early life and anti-CD20 treatment outcomes in pediatric patients with these conditions. Safety and tolerability considerations, optimal timing of therapy, and remaining gaps in evidence are also explored, highlighting the need for age-specific biomarkers and prospective studies to better define individualized treatment strategies and to clarify long-term consequences of B-cell-depleting therapies..."

Journal • Review • CNS Disorders • Hematological Disorders • Infectious Disease • Leukopenia • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Neutropenia • Pediatrics • Rare Diseases • Solid Tumor

Novartis delivered sales growth in Q2… (Novartis Press Release) - "Net sales grew +1% (cc, +3% USD), with core operating income flat (cc and USD); Sales growth driven by priority brands including Kisqali (+43% cc), Kesimpta (+32% cc), Scemblix (+89% cc), Pluvicto (+43% cc) and Leqvio (+59% cc); Core operating income margin1 was 41.2%, -70 basis points (cc)."

Sales • Castration-Resistant Prostate Cancer • Dyslipidemia • Estrogen Receptor Positive Breast Cancer • Familial Hypercholesterolemia • HER2 Negative Breast Cancer • Heterozygous Familial Hypercholesterolemia • Hormone Receptor Positive Breast Cancer • Immunology • Multiple Sclerosis • Philadelphia Chromosome Positive CML • Urothelial Cancer