Fumaderm (dimethyl fumarate) / Biogen - LARVOL DELTA

Proteomic Cysteine Profiling Links DMI and DMF to Antiviral Activity. (PubMed, Proteomics) - "Our findings nominate RIG-I as a shared candidate target of DMI and DMF and associate altered cysteine reactivity with the dampening of antiviral and inflammatory signaling. This work provides new mechanistic insights into the immunosuppressive actions of these electrophiles and highlights their potential as chemical probes and therapeutic leads for modulating innate immunity."

Journal • DDX58

Infection and Relapse Outcomes In People with MS Transitioning from Standard Interval Dosed Anti-CD20 Therapies to Fumarates or to Extended Interval Dosed Anti-CD20s (CMSC 2026) - " PwMS (age 18-64 y) were identified retrospectively from 01 Jan 2017 to 31 Dec 2023 in the Komodo Health claims database who had initiated FUM (dimethyl fumarate or diroximel fumarate) or EID anti-CD20 (ocrelizumab [OCR) or ofatumumab (OFA)... Annualized infection rates were significantly lower for PwMS transitioning from anti-CD20 to FUM compared with PwMS transitioning from SID to EID anti-CD20s. Transitioning from anti-CD20s to FUM was also associated with a lower ARR compared to extending the dosing interval with the anti-CD20; this finding warrants further investigation but does suggest that transitioning to FUM may have at least similar effectiveness as anti-CD20 EID in controlling relapses. Study Support: Biogen"

CNS Disorders • Multiple Sclerosis

Comparative Effectiveness of Diroximel Fumarate Versus Dimethyl Fumarate In Persons with Multiple Sclerosis: A US Claims Analysis of Relapse Outcomes (CMSC 2026) - "The results of this real-world analysis indicate DRF may be more effective than DMF in reducing relapses over 1 and 2 years of treatment in pwMS. These findings warrant further investigation but suggest the improved tolerability profile of DRF versus DMF may contribute to improved real-world effectiveness for pwMS. Study Support: Biogen."

HEOR • Late-breaking abstract • CNS Disorders • Multiple Sclerosis

Comparative Effectiveness of Diroximel Fumarate vs. Dimethyl Fumarate in Persons with Multiple Sclerosis: A US Claims Analysis of Relapse Outcomes. (PubMed, Adv Ther) - "The results of this real-world analysis indicate DRF may be more effective than DMF in reducing relapses over 1 and 2 years of treatment in pwMS."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

The use of baseline risk in cost-effectiveness modelling of competing interventions. (PubMed, Value Health) - "Our findings show that integrating baseline risk modelling with NMA and cost-effectiveness analysis provides more informative decision-making than relying on average effects. Treatment value can vary substantially across the risk spectrum, indicating that optimal therapy selection is strongly dependent on individual patient risk."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

A Comparative Effectiveness Analysis of Fumarates versus Cladribine in People With MS Transitioning From Anti-CD20 Therapies (AAN 2026) - "Strategies to mitigate risks with anti-CD20s include switching to oral DMTs such as FUM (dimethyl fumarate; diroximel fumarate) or oral CLAD...Additional results will be presented. Conclusions These results indicate that relapse rates were comparable between FUM and CLAD and suggest FUM may be as effective as CLAD in controlling disease activity in PwMS transitioning from anti-CD20 therapies."

HEOR • CNS Disorders • Infectious Disease • Multiple Sclerosis

A Comparative Effectiveness Analysis of Fumarates versus Cladribine in People with MS Transitioning from Anti-CD20 Therapies (ACTRIMS Forum 2026) - "Strategies to mitigate risks with anti-CD20 include switching to oral DMTs such as a fumarate (FUM; dimethyl fumarate; diroximel fumarate) or oral cladribine (CLAD)... These results indicate that relapse rates were comparable between FUM and CLAD and suggest FUM may be as effective as CLAD in controlling disease activity in PwMS transitioning from anti-CD20 therapies.Study Supported by: Biogen"

HEOR • CNS Disorders • Infectious Disease • Multiple Sclerosis

Safety and efficacy of opicinumab in participants with relapsing multiple sclerosis (AFFINITY Part 1): A randomized, controlled, phase 2 trial. (PubMed, Mult Scler) - P2 | "Although the AFFINITY study did not show significant difference in mean ODRS between opicinumab and placebo groups, data from AFFINITY interpreted with the previous SYNERGY study may inform the design of future remyelination trials."

Journal • P2 data • CNS Disorders • Inflammation • Multiple Sclerosis • Solid Tumor

Effect of diroximel fumarate on gut dysbiosis and autoimmunity in the central nervous system. (PubMed, Int Immunopharmacol) - "Furthermore, DRF reduced the production of CCL22, a chemokine derived from macrophages. Overall, our findings suggest that DRF can reduce neuroinflammation by lowering the production of IL-17, inhibiting the development of α4β1 + CD4+ T cells and α4β7 + CD4+ T cells in the lymph nodes, and alleviating dysfunction associated with gut dysbiosis and intestinal permeability."

Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • CCL2 • CCL22 • CD4 • IL17A • LCN2

Patient and healthcare provider experience of diroximel fumarate: considerations for selecting disease-modifying therapy. (PubMed, Neurodegener Dis Manag) - "A real-world, patient-focused survey on MS treatment suggested DRF was well tolerated and associated with patient-reported physical benefits. HCP-reported reasons for selecting DRF included efficacy and tolerability issues with prior DMT."

Journal • CNS Disorders • Multiple Sclerosis

Long-Term Treatment with Fumarates versus Anti-CD20 Monoclonal Antibodies and Infection-related Outcomes in Patients with Multiple Sclerosis (ECTRIMS 2025) - " The study included 1956 PS-matched PwMS, with 652 FUM initiators (614 dimethyl fumarate, 38 diroximel fumarate) and 1304 anti-CD20 initiators (1296 ocrelizumab, 8 ofatumumab)... PwMS treated with FUM experienced significantly lower long-term infection-related HCRU compared with those on anti-CD20s, with similar relapse outcomes. The difference in infection risk between FUM and anti-CD20 therapies increased with treatment duration, consistent with prior evidence that infection risk rises with long term B-cell depletion. These findings underscore the long-term risk-benefit considerations when selecting or maintaining DMTs in MS management."

Clinical • CNS Disorders • Infectious Disease • Multiple Sclerosis

Prospective De-Escalation from B-cell Depletion to Fumarates: Interim 1-year results (ECTRIMS 2025) - "Half were on ocrelizumab, 40% on rituximab, and 10% on ofatumumab. Eight patients transitioned to diroximel fumarate (DRF) and 2 to dimethyl fumarate (DMF)... De-escalating from B-cell depleting therapies to fumarates appears to maintain efficacy early in this transition. This is a two-year study that is ongoing to better evaluate efficacy and safety of this treatment switch."

Clinical • CNS Disorders • Infectious Disease • Multiple Sclerosis

cutaneous lymphoid hyperplasia-grey case (EADV 2025) - "These included methotrexate, intralesional steroid, interferon-alpha, cyclosporine, Fumaderm, Intralesional and Intravenous Rituximab. This case demonstrates how challenging the diagnosis and treatment of idiopathic CLH can be. Dupilumab cleared effectively both eczema and CLH lesions. This case highlights a future potential role of targeted biologics and the need to explore immunomodulatory strategies in similar cases."

Clinical • Atopic Dermatitis • Dermatology • Eosinophilia • Hematological Malignancies • Infectious Disease • Inflammation • Inflammatory Arthritis • Langerhans Cell Histiocytosis • Lupus • Lyme Disease • Lymphoma • IL13 • IL4 • STAT6

Comparative Effectiveness of Fumarates Versus Sphingosine-1-Phosphate Receptor Modulators in Black Patients with Multiple Sclerosis. (PubMed, Neurol Ther) - "This real-world, claims-based analysis demonstrates that fumarates and S1P receptor modulators have similar effectiveness in reducing relapses among Black PwMS, with > 72% of patients in both treatment groups remaining relapse-free at 24 months. Given the underrepresentation of Black patients in MS clinical trials, these results provide valuable real-world evidence to guide treatment decisions for this population."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

Real-World Treatment Outcomes in Black, Hispanic, Asian, and White People with Multiple Sclerosis Treated with Fumarates in the USA. (PubMed, Neurol Ther) - "Consistent with prior studies, these results demonstrate the effectiveness of fumarates across racial and ethnic MS subgroups. This is the largest analysis to date of the treatment effects of any individual class of DMT in Black and Hispanic PwMS. Infographic available for this article."

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

Real-World Treatment Outcomes in People with Multiple Sclerosis who Switched From Teriflunomide to Fumarates (ACTRIMS Forum 2025) - "There is limited understanding of the real-world clinical disease activity and healthcare resource utilization (HRU) and healthcare costs (HCC) among pwMS who switch from teriflunomide (TERI) to fumarate (FUM; either dimethyl fumarate [DMF] or diroximel fumarate [DRF]) therapies.Objectives: To estimate pre- and post-switch annualized relapse rate (ARR), time to relapse, 1-yr pre-index vs post-index MS-related HRU and HCC in pwMS who switched from TERI to FUM. This retrospective analysis of the Komodo Health claims database included pwMS with ≥1 claim for TERI and MS diagnosis (ICD-10 code G35) between 1 Jan 2016 and 31 May 2022... ARRs decreased after switching from TERI to FUM, but was not statistically significant; however, patients had lower MS-related HRU and HCC after switching from TERI to FUM. Our results suggest FUM may be a reasonable and a cost-effective option for pwMS on prior TERI treatment.Study Supported by: Biogen"

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

Real-world Treatment Outcomes in Black, Hispanic, Asian, and White People with Multiple Sclerosis Treated with Fumarates (P4-6.005). (PubMed, Neurology) - "Dimethyl fumarate (DMF) and diroximel fumarate (DRF) are disease-modifying therapies for relapsing MS...Dr. Shankar has stock in Biogen."

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

LymphoTEC: a Retrospective Real-World Study on Lymphocyte Reconstitution After Lymphopenia in Patients with Multiple Sclerosis Treated with Dimethyl Fumarate in France. (PubMed, Adv Ther) - P=N/A | "LymphoTEC confirms previous reports on DMF-induced lymphopenia; the benefit-risk profile of DMF remains favorable. Most cases of lymphopenia were not severe and ALC reconstitution typically occurred within 4 months of DMF discontinuation. Patients with shorter and milder lymphopenia had faster ALC reconstitution."

Clinical • Journal • Real-world evidence • Retrospective data • CNS Disorders • Diabetes • Infectious Disease • Metabolic Disorders • Multiple Sclerosis • Rare Diseases

Chemoproteomic Profiling of Clickable Fumarate Probes for Target Identification and Mechanism of Action Studies. (PubMed, ACS Chem Biol) - "To better understand the mechanism of action of DMF and its active metabolite, monomethyl fumarate (MMF), we designed and utilized clickable probes to visualize and enrich probe-modified proteins. We further perform quantitative chemoproteomics analysis for proteome-wide target identification and validate several unique and shared targets of DMF and MMF, which provide insight into the reactivity, selectivity, and target engagement of fumarates."

Journal • CNS Disorders • Multiple Sclerosis

Long-Term Safety and Effectiveness of Dimethyl Fumarate in Patients with Multiple Sclerosis Treated in Routine Medical Practice: Final Analysis of the ESTEEM Study. (PubMed, Neurol Ther) - P=N/A | "DMF demonstrated a safety profile in real-world clinical practice consistent with the known profile of DMF. Relapse rates were low and both ARR and PROs remained stable over time."

Journal • CNS Disorders • Fatigue • Gastrointestinal Disorder • Infectious Disease • Multiple Sclerosis

Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients. (PubMed, Adv Ther) - P=N/A, P3 | "ESTEEM found no unexpected safety signals in older patients and annualized relapse rates (ARRs) were significantly reduced in both age groups. Both studies indicated that DMF is efficacious and has a favorable safety profile in patients with RRMS aged ≥ 50 years."

Journal • P3 data • P4 data • Real-world • Real-world evidence • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Multiple Sclerosis • CD4 • CD8

Patient-reported disability progression outcomes among patients with multiple sclerosis: Results of an outcomes-based agreement. (PubMed, J Manag Care Spec Pharm) - "Of the remaining 184 eligible patients (107 on dimethyl fumarate and 77 on interferon β-1a), 21 (11%) patients had confirmed disability progression (6 on dimethyl fumarate [5.6%] and 15 on interferon β-1a [19.5%]). Our findings suggest that meaningful patient-reported outcomes, such as disability progression, can be operationalized in an innovative OBA."

Journal • CNS Disorders • Multiple Sclerosis • IFNB1

A case of cutaneous and osteosarcoidosis successfully treated with Tofacitinib (EADV 2024) - "Since diagnosis in 2001 via skin biopsy; treatment had been unsuccessful, provided short lived benefit or was poorly tolerated (due to recurrent infections) with Certolizumab, Adalimumab, Infliximab, Hydroxychloroquine, Leflunomide, Methotrexate, Mycophenolate mofetil, Minocycline, Azathioprine, Fumaderm, Thalidomide, Phototherapy (PUVA) and Pentoxifylline. Tofacitinib is a JAKi approved for the treatment of inflammatory arthropathies and ulcerative colitis. JAK proteins are associated with cell surface cytokine receptors, and so are early mediators of cell response to inflammation whereby STAT driven transcription is initiated. In sarcoidosis, it is predominantly Type 1 inflammatory cytokines and interferon gamma that bind to JAK associated cytokine receptors1."

Clinical • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Rheumatology • Sarcoidosis • Ulcerative Colitis • IFNG

A 2-stage model of heterogenous treatment effects for brain atrophy in multiple sclerosis utilizing the MS PATHS research network. (PubMed, Mult Scler Relat Disord) - "The relative benefit of selecting higher efficacy treatments may vary depending on patients' baseline brain atrophy risk. Poor outcomes are predicted in individuals with high baseline risk who are treated with low-efficacy DMTs."

Journal • CNS Disorders • Multiple Sclerosis

Clinical Characteristics and Treatment Outcomes in Patients With Multiple Sclerosis Treated With Natalizumab Who Switched to Moderate-Efficacy Oral Disease-Modifying Therapies (CMSC 2024) - "OBJECTIVES: This analysis estimated annualized relapse rate (ARR), time to first relapse, health care encounters (HCEs), and health care costs (HCCs) in patients with stable MS who switched from NTZ to FUM (dimethyl fumarate/diroximel fumarate) vs those who switched from NTZ to S1Ps (fingolimod/siponimod/ponesimod/ ozanimod)... These data provide real-world clinical characteristics as well as treatment outcomes of patients with stable MS who switched from NTZ to FUM or S1Ps; after PS matching, no significant differences were observed in relapse outcomes, HCEs, or HCCs."

Clinical • Late-breaking abstract • CNS Disorders • Multiple Sclerosis