Lemtrada (alemtuzumab) / Sanofi, Bayer - LARVOL DELTA

Alemtuzumab-associated accommodative spasm in a kidney transplant recipient: a rare neuro-ophthalmic complication (UKKW 2026) - "Implication Transplant clinicians should consider accommodative spasm in patients with unexplained blurred vision and request cycloplegic refraction before attributing symptoms to metabolic derangements or drug toxicity. Next step Systematic incorporation of ophthalmic surveillance into transplant pharmacovigilance, registry-based adverse event reporting, and cross-specialty awareness in both nephrology and ophthalmology guidelines are needed to clarify incidence, mechanisms, and long-term outcomes of this rare complication."

Clinical • CNS Disorders • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Multiple Sclerosis • Nephrology • Ocular Inflammation • Ophthalmology • Optic Neuritis • Retinal Disorders • Transplantation

Analysis of herpes zoster cases in multiple sclerosis patients treated with disease-modifying drugs: insights from the EudraVigilance database. (PubMed, Neurol Neurochir Pol) - "While treating MS patient with DMTs the risk of adverse HZ should be evaluated. Vaccination against HZ should be recommended for patients to benefit the most from the available treatment."

Journal • CNS Disorders • Herpes Zoster • Infectious Disease • Multiple Sclerosis • Neuralgia • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Varicella Zoster

Comparative Efficacy of 35 Disease-modifying Therapies in Relapsing-remitting MS: A Network Meta-analysis Identifying Top Performers for Relapse, MRI Activity, and Disability Progression (AAN 2026) - "At 6 months, SC IFNbeta-1b (RR 0.14) and SC Ofatumumab (RR 0.33) were associated with the lowest disability progression... Alemtuzumab and the Ocrelizumab formulations were highly effective for relapse prevention, while Ponesimod + DMF and Natalizumab formulations reduced MRI lesions. Mitoxantrone was associated with long-term prevention of disability progression."

Retrospective data • CNS Disorders • Multiple Sclerosis

The Exit Strategy: Clinical Outcomes and Safety of De-escalating High-efficacy Therapies in Multiple Sclerosis (AAN 2026) - ""Stable" PwMS transitioned from natalizumab (50%), ocrelizumab (49%) or alemtuzumab (1%). Most PwMS were de-escalated to cladribine (49%) or a fumarate (41%)... These findings suggest that age may be an influential factor in determining stability after de-escalation and de-escalation from ocrelizumab appears to be safer than from natalizumab. Therefore, the decision to de-escalate should be based on individual patients' characteristics."

Clinical • Clinical data • CNS Disorders • Multiple Sclerosis

Urinary Tract Infections and Urosepsis in Multiple Sclerosis: Insights from FDA Pharmacovigilance Data (AAN 2026) - "Ocrelizumab had the greatest association with UTI, and natalizumab, alemtuzumab, and interferon-beta-1a exhibited safety signals for both outcomes across all sex and age subgroups. This real-world pharmacovigilance analysis identifies disproportionate reporting of UTI and urosepsis across several MS DMTs, underscoring their contribution to morbidity and mortality. These associations likely reflect both therapy-related immunologic effects and disease-intrinsic factors, particularly neurogenic bladder dysfunction. These findings highlight the need for vigilant infection surveillance, proactive bladder management, and individualized risk assessment in MS care."

Adverse events • CNS Disorders • Immunology • Infectious Disease • Multiple Sclerosis • Nephrology • Urology

Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system. (PubMed, Mult Scler Relat Disord) - "Patient counseling on early appendicitis warning signs and indications for urgent evaluation may be warranted for people with MS on DMTs."

Adverse events • Journal • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Multiple Sclerosis

Real-world Utilization of a Novel Multi-analyte Blood-based Biomarker Panel, the Octave® Multiple Sclerosis Disease Activity (MSDA) Test in Clinical Practice Across the United States (AAN 2026) - "Baseline demographics include mean age of 52.0 years, 77.0% female, 76.8% White, 14.7% Black, and 4.4% Hispanic.Among patients with DMT data, 44.4% were on high-efficacy DMTs (anti-CD20s, natalizumab, cladribine, alemtuzumab) at their latest test; 34.2% were not on a DMT. This report highlights the growing use of the MSDA Test in US clinical practice and its clinical utility for tracking meaningful change. Ongoing research is essential to fully realize the Octave® MSDA test's impact and ensure smooth integration into clinical workflows."

Biomarker • Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis

Herpes Zoster Reports in Multiple Sclerosis Patients Treated With Disease Modifying Drugs – An Analysis of EudraVigilance Database (AAN 2026) - "Values form 0.2% (glatiramer acetate), to 3.9% (cladribine) of all adverse reports, mark HZ as a relevant complication during MS treatment. The highest ROR values were noted for fingolimod (4,09), cladribine (3,33) and alemtuzumab (2,27), followed by siponimod (1,97). The lowest RORs were calculated for glatiramer acetate (0,17), interferons (≈0,21) and teriflunomide (0,35)... Our study shows that some DMTs used in MS might be linked with significant increase in the risk of HZ infection development. While treating MS patient with DMTs, clinicians should always carefully evaluate the risk of adverse HZ. Moreover, vaccination against HZ should be recommended, to reduce the risk of HZ infection, enabling patients to benefit fully form the available MS treatment."

Clinical • CNS Disorders • Herpes Zoster • Infectious Disease • Multiple Sclerosis • Neuralgia • Ophthalmology • Varicella Zoster

Disparities in Geographic Access to Infusion Centers Does not Impact the Use of High Efficacy Infusion Disease Modifying Therapies in Multiple Sclerosis (AAN 2026) - "A multivariable logistic regression model was used to evaluate the association between geographic access to infusion centers and the use of infusion DMTs (CD20 monoclonal antibodies, natalizumab, alemtuzumab, cyclophosphamide) adjusting for age, sex, race, ethnicity, education, MS disease duration, MS course, patient determined disease steps (PDDS), area deprivation index (ADI), and rural-urban commuting code (RUCA). Disparities to geographic access to infusion centers exist but distance did not impact the use of high efficacy infusion DMTs for patients. These results suggest that geographic barriers to resources can be mitigated to deliver highly effective treatments."

Clinical • CNS Disorders • Multiple Sclerosis

ADAs to Alemtuzumab (clinicaltrials.gov) - P=N/A | N=15 | Completed | Sponsor: Queen Mary University of London | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Association Between Disease-modifying Therapies for Multiple Sclerosis and Cancer Reporting: A Disproportionality Analysis Using the U.S. Food and Drug Administration Adverse Event Reporting System Database (AAN 2026) - "Subgroup analyses identified positive safety signals for specific malignancy subgroups with ROR (95% confidence intervals) values as follows: for alemtuzumab, non-Hodgkin B-cell lymphoma 6.49 (2.67–15.81), endocrine neoplasms malignant and unspecified (NMU) 3.63 (2.09–6.28), and skin NMU 2.99 (2.00–4.49); for fingolimod, skin NMU 4.33 (4.02–4.66) and non-Hodgkin T-cell lymphoma 2.15 (1.57–2.97); for cladribine, leukemias 2.43 (1.43–4.13) and renal and urinary tract NMU 2.18 (1.23–3.86); for rituximab, gastrointestinal NMU 3.13 (1.93–5.06); for other S1P modulators, skin NMU 2.04 (1.54–2.68); for interferon beta-1a, nervous system NMU 2.82 (2.56–3.10) and endocrine NMU 2.45 (2.23–2.69); and for interferon beta-1b, endocrine NMU 2.30 (1.78–2.98). No association was found between DMTs and overall cancer reporting. However, several subgroup analyses demonstrated positive safety signals, underscoring the need for population-based studies to provide more definitive evidence."

Adverse events • B Cell Lymphoma • CNS Disorders • Endocrine Cancer • Lymphoma • Multiple Sclerosis • Oncology • T Cell Non-Hodgkin Lymphoma

Treatment outcomes of high-efficacy disease-modifying therapies in patients with relapsing-remitting multiple sclerosis: A longitudinal observational study. (PubMed, Mult Scler Relat Disord) - "Early initiation of HE-DMTs in RRMS patients had a significant clinical impact on disease activity and disability. Treatment effectiveness parameters were lower with later lines of therapy, highlighting the importance of early therapeutic intervention. High tolerability varied among DMTs, demonstrating the need for individualized treatment decisions."

Clinical • Journal • Observational data • CNS Disorders • Multiple Sclerosis

Post-Marketing Skin Cancer Safety Concerns with Fingolimod in MS (ACTRIMS Forum 2026) - "For each skin cancer-related adverse event (all skin cancer as well as by subtype for cutaneous melanoma, cutaneous basal cell carcinoma, and cutaneous squamous cell carcinoma), the proportional reporting ratio (PRR), information component (IC), reporting odds ratio (ROR), and adjusted ROR (aROR) were computed using natalizumab and alemtuzumab as the active comparator reference group. Fingolimod was associated with disproportionate reporting of skin cancer, with the strongest association observed for cutaneous basal cell carcinoma. These findings support the need for dermatologic monitoring and warrant evaluation in future prospective cohort studies. The application of active-comparator restricted disproportionality analysis may help improve signal detection study design in future pharmacovigilance studies."

Clinical • P4 data • Basal Cell Carcinoma • CNS Disorders • Cutaneous Melanoma • Genetic Disorders • Melanoma • Multiple Sclerosis • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Real-World Experience with Cladribine Tablets in a Relapsing Multiple Sclerosis Cohort from Puerto Rico (ACTRIMS Forum 2026) - "The objective of this study is to report demographics and clinical and safety outcomes with CladT in a real-world cohort of people with relapsing multiple sclerosis (PwRMS), including a subgroup of patients who switched to CladT from an infusion therapy (ocrelizumab, natalizumab, or alemtuzumab). This single-center, retrospective study evaluated PwRMS aged ≥18 years treated with ≥1 course of CladT from May 2020 to May 2025 at the San Juan MS Center, Guaynabo, Puerto Rico. Clinical outcomes with CladT in this RWE cohort demonstrated sustained efficacy up to Year 5. Lymphocyte count dynamics, grades of lymphopenia, and AEs were consistent with those from randomized clinical trials. Outcomes in PwRMS transitioning from an infusion therapy did not differ from the overall cohort."

Clinical • Real-world • Real-world evidence • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease

Effectiveness and Safety of Switching to Cladribine Tablets in US Patients with RMS Experiencing High Disease Activity or Disease Breakthrough Despite Current DMT Use (ACTRIMS Forum 2026) - "Real-world data on the effectiveness of switching to cladribine tablets (CladT), a short-course HE DMT approved in the United States (US) for RMS, in patients with high disease activity (HDA) or disease breakthrough remain limited. Real-world, retrospective, and prospective study across 17 US centers in 61 pwRMS who switched to CladT (on/before January 31, 2022) from moderate- or HE DMTs (fumarates [n=9], sphingosine-1-phosphate receptor modulators [n=11], natalizumab [n=12], alemtuzumab [n=12], and anti-CD20s [n=17]) due to HDA/disease breakthrough. These US real-world findings support the use of CladT as an effective and safe switching option for pwRMS experiencing HDA/disease breakthrough despite moderate- or HE DMT use."

Clinical • CNS Disorders • Multiple Sclerosis

Real-world Utilization of a Novel Multi-Analyte Blood-Based Biomarker Panel, the Octave® Multiple Sclerosis Disease Activity (MSDA) Test in Clinical Practice Across the United States (ACTRIMS Forum 2026) - "Baseline demographics include mean age 52.0 years, disease duration 13.8 years, 77.0% female, 76.8% White, 14.7% Black, and 4.4% Hispanic.Among patients with available DMT data, 44.4% were on high-efficacy DMTs (anti-CD20s, natalizumab, cladribine, alemtuzumab) at their latest test, while 34.2% reported as not on a DMT. This report highlights the growing use of the MSDA in US clinical practice and the test's clinical utility for tracking meaningful improvement/decline. Ongoing research is essential to fully realize the Octave® MSDA's impact and ensure its smooth integration into clinical workflows."

Biomarker • Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis

[Translated article] Alemtuzumab in relapsing-remitting multiple sclerosis in clinical practice: Annual NEDA-3 follow-up for up to 4 years. (PubMed, Farm Hosp) - "Alemtuzumab has proven to be effective, over 4 years, in clinical practice in patients with RRMS according to the different parameters of the NEDA-3 concept."

Journal • CNS Disorders • Multiple Sclerosis

B-cell-driven relapse and anti-CD20 rescue therapy after Alemtuzumab in RRMS: case report and literature review. (PubMed, Front Immunol) - "Early ocrelizumab switch resulted in rapid clinical and radiological recovery and sustained stability...Prior exposure to fingolimod has been observed in several cases, but does not uniformly account for the observed phenotype...Lymphocyte subtyping should be performed, and a predominance of CD19+ B cells can guide a timely therapeutic switch to anti-CD20 therapy. Further studies are needed to define whether this represents a distinct post-IRT immunopathological entity."

Journal • Review • CNS Disorders • Inflammation • Multiple Sclerosis

Real-world COVID-19 immunity in multiple sclerosis (CoVaR-MS): A longitudinal follow up study. (PubMed, Mult Scler Relat Disord) - "We conducted a real-world longitudinal study (n = 235) including PwMS (n = 205; Alemtuzumab, Dimethyl fumarate, Fingolimod, Interferon, Natalizumab, Ocrelizumab, no-DMT) and Healthy volunteers (HV) (n = 30)...Ocrelizumab lowered serological but maintained cellular immunity; whilst Fingolimod lowered both. Data support boosters in PwMS, more so on Ocrelizumab and Fingolimod."

Journal • Real-world evidence • CNS Disorders • Immunology • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Respiratory Diseases

Highly active multiple sclerosis - An important, yet inaccurate concept. (PubMed, Mult Scler Relat Disord) - "Brazilian neurologists show substantial agreement in identifying clinical and radiological signs of HA-MS and favor early, high-efficacy treatment strategies. These findings highlight the need for clear, standardized criteria to guide consistent diagnosis and timely therapeutic intervention, ultimately improving patient care in MS."

Journal • CNS Disorders • Multiple Sclerosis

Management of alemtuzumab-induced Graves' disease in pregnancy: a case report and literature review. (PubMed, Front Immunol) - "She was treated with methimazole (MMI), with multiple dose adjustments throughout pregnancy to maintain euthyroidism. The present case adds to the limited literature on ALZ-induced GD in pregnancy, providing further insight into the variability of disease onset, progression, and neonatal outcomes. It underscores the importance of close monitoring and a multidisciplinary approach to ensure optimal maternal and fetal health."

Journal • Review • CNS Disorders • Endocrine Disorders • Grave’s Disease • Immunology • Multiple Sclerosis

B cell tolerance checkpoint function in multiple sclerosis and transient CD52 depletion. (PubMed, J Neuroimmunol) - "In BCR repertoire analysis, alemtuzumab-treated patients showed lower mean naïve complementarity-determining region 3 (CDR3) net charge compared to HDs (P = 0.0036), an interesting yet isolated finding warranting further investigation. Overall, transient CD52 depletion did not seem to affect major changes in peripheral B cell tolerance checkpoint function as assessed with naïve B cell cloning and BCR NGS, while observations in the described setting may also apply to other immune reconstitution therapies."

Journal • CNS Disorders • Multiple Sclerosis • CD52

MIGRA-MS: A case series on chronic migraine and multiple sclerosis (EHF-EHC 2025) - "Prior treatments included interferons and glatiramer acetate; current therapies consisted of ocrelizumab, natalizumab, alemtuzumab, teriflunomide, or dimethyl fumarate...All received a median of three classic preventives (amitriptyline in all cases) and onabotulinumtoxinA (PREEMPT, 155 IU) with only one responder; two patients received an extended dose (195 IU) without benefit and later CGRP monoclonal antibodies (galcanezumab, erenumab, eptinezumab) with no response, and atogepant with only transient or partial benefit... Migraine is more prevalent in MS patients than in the general population, and their coexistence represents a therapeutic challenge. In this case series of relapsing–remitting MS with chronic resistant migraine, response to onabotulinumtoxinA and antiCGRP therapies was limited, with no drug interactions or adverse effects observed. An individualized approach and further studies are needed to assess emerging treatments in this subgroup."

Clinical • CNS Disorders • Migraine • Multiple Sclerosis • Pain

Secondary Autoimmune Dermatological Disorders Induced by Multiple Sclerosis Biological Immunotherapy Agents: A Systematic Review of Case Reports. (PubMed, Iran J Pharm Res) - "The search strategy employed combinations of keywords such as "multiple sclerosis" with specific biological agents ("Natalizumab" OR "Ocrelizumab" OR "Rituximab" OR "Alemtuzumab" OR "Ofatumumab" OR "Ublituximab") and "case report", incorporating relevant Medical Subject Headings (MeSH) terms...The employed injectable MS immunotherapies demonstrate various autoimmune adverse reactions that have been documented across numerous case reports. This review examines different categories of secondary autoimmune complications and explores the theoretical mechanisms underlying their development."

Journal • CNS Disorders • Immunology • Multiple Sclerosis

Case Reports of Teprotumumab as Treatment for Monoclonal Antibody-Induced Thyroid Orbitopathy. (PubMed, Reports (MDPI)) - "Background and Clinical Significance: Targeted biologic therapies, especially monoclonal antibodies (mAbs) such as nivolumab and alemtuzumab, have revolutionized treatment for malignancies and autoimmune conditions but can cause rare immune-related adverse events (IRAEs), including orbitopathy. Clinicians should maintain an awareness of orbital complications in patients receiving mAbs to enable prompt diagnosis and intervention, minimizing visual morbidity. Further studies are needed to clarify the pathogenesis of mAb-associated orbitopathy and to establish evidence-based treatment protocols for these rare but impactful complications."

Journal • CNS Disorders • Immunology • Melanoma • Multiple Sclerosis • Oncology • Ophthalmology • Solid Tumor • Thyroid Eye Disease