Retrospective Evaluation of Attacks, EDSS Scores, and MRI Changes Before the Start of Treatment and One Year After the Start of Treatment in Patients Followed by a Diagnosis of Multiple Sclerosis and Using Ocrelizumab in Our Clinic
Abstract
Objective: Depletion of B cells by anti-CD20 monoclonal antibodies has been proven to reduce relapsing remitting multiple sclerosis (RRMS) activity and progression of primary progressive MS (PPMS). In our study, we aimed to retrospectively present our clinical experience and contribute to real-life data after the use of Ocrelizumab.
Material and Methods: Patients aged 18-55 years using Ocrelizumab and diagnosed with MS by McDonald's 2017 criteria were included. Neurological examination findings and EDSS findings available in our file records were used to evaluate the level of disability. Patients with MRI lesions consistent with their clinical complaint lasting more than 24 hours were evaluated as an attack. Patients' ages, MS diagnosis times, and previous immune modulatory treatments were recorded. The number of T2, FLAIR sequence MRI lesions, EDSS before ocrelizumab, and the number of T2, FLAIR sequence MRI lesions 1 year after receiving ocrelizumab were recorded. After 1 year of follow-up, the absence of attacks, no increase in the number of lesions in MRI, and no progress in EDSS were accepted as NEDA 3.
Results: Our cases in this study include 30 MS patients. Patients were 26.7% relapsing remitting MS (RRMS), 26.7% primary progressive MS (PPMS), and 46.7% secondary progressive MS (SPMS). There was no attack in 87.5% of the RRMS patient group. In the SPMS patient group, no attacks were observed after ocrelizumab in the cases with attacks. In our study, the rate of patients who did not develop new T2 lesions and whose lesions disappeared was 62.5% in the RRMS patient group, 78.5% in the SPMS patient group, and 75% in the PPMS patient group. In the total patient group, the rate of patients without EDSS increase was 93% (28 patients).
Conclusion: In our study, it was determined that ocrelizumab was effective by reducing the attack rates, preserving the EDSS scores and preventing the increase in the lesion burden. Our findings are consistent with real-life data.
Keywords
References
- Sorensen PS, Blinkenberg M. The potential role for ocrelizumab in the treatment of multiple sclerosis: Current evidence and future prospects. Ther Adv Neurol Disord. 2016;9(1):44–52
- Barkhof F, Kappos L, Wolinsky J. S, Li D. K, Bar-Or A, Hartung H. P Hauser S. L. Onset of clinical and MRI efficacy of ocrelizumab in relapsing multiple sclerosis. Neurology, 2019: 93(19), e1778-e1786
- Rojas JI, Patrucco L, Fruns M, Hornung G, Flores J, Contenttı EC, et al. Real-world experience of ocrelizumab in multiple sclerosis patients in latin america. Arq Neuropsiquiatr. 2021;79(4):305–9
- Ellwardt E, Rolfes L, Klein J, Pape K, Ruck T, Wiendl H, et al. Ocrelizumab initiation in patients with MS: A multicenter observational study. Neurol Neuroimmunol neuroinflammation. 2020;7(4):1–9
- Fernandez-Diaz E, Perez-Vicente JA, Villaverde-Gonzalez R, Berenguer-Ruiz L, Candeliere Merlicco A, Martinez-Navarro ML, et al. Real-world experience of ocrelizumab in multiple sclerosis in a Spanish population. Ann Clin Transl Neurol. 2021;8(2):385–94
- Moss Brandon et al “Real-World Experience with Ocrelizumab (P6.356).” Neurology 90.15 Supplement (2018): P6.356. Web. 01 Sept2022
- Garcia-Cañibano B, Ouanes S, Ganesan GS, Yousuf W, Humos B, Baig T, et al. Real-world experience of ocrelizumab in multiple sclerosis in an Arab population. J Drug Assess [Internet]. 2021;10(1):106–13
- Weinstock-Guttman B, Bermel R, Cutter G, Freedman MS, Leist TP, Ma X, et al. Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous disease-modifying therapy: A nonrandomized controlled trial. Mult Scler J. 2022;28(5):790–800
- Koc E, Saridas F, Ceylan D, Turan O, Ozkaya G. Real-world experience of ocrelizumab in MS in the Turkish population: A singlecenter study . European Journal of Neurology 2022; 29:792
- Bolling J, Vasquez M, Eduardo VSC, Carlson A, Gyang T. Real-world Experience with Ocrelizumab - A Safety Analysis (4199) Neurology Apr 2020;94(15 Supplement):4199
- López Ruiz R, Eichau S, Guerra Hiraldo J. D, Dotor García-Soto J, Ruiz De Arcos M, Ruiz-Peña J. L. Real world data on the use of ocrelizumab. Incidence of lymphopenia, B-cell and immunoglobulins evolution. Multiple Sclerosis Journal 2021;631-631.
Kliniğimizde Multiple Skleroz Tanısı ile Takip Edilen ve Ocrelizumab Kullanan Hastaların Tedavi Başlangıcından Önce ve Bir Yıl Sonraki Atak, EDSS Skoru ve MR Değişikliklerinin Retrospektif Değerlendirilmesi
Abstract
Amaç: Anti-CD20 monoklonal antikorlar tarafından B hücrelerinin tüketilmesinin, relapsing remitting Multiple Skleroz (RRMS) aktivitesini ve primer progresif MS'nin (PPMS) ilerlemesini azalttığı kanıtlanmıştır. Biz araştırmamızda Ocrelizumab kullanımı sonrasında retrospektif olarak klinik tecrübemizi ortaya koymayı, gerçek yaşam verilerine katkı sağlamayı hedefledik.
Gereç ve Yöntemler: McDonald 2017 kriterlerine göre değerlendirilerek MS tanısı almış Ocrelizumab kullanan 18-55 yaş aralığındaki hastalar dahil edildi. Engellilik düzeyinin değerlendirilmesinde dosya kayıtlarımızda mevcut olan nörolojik muayene bulguları ve EDSS bulguları kullanıldı. 24 saatten fazla süren klinik yakınması ile uyumlu MRG lezyonları olan hastaları atak olarak değerlendirildi. Hastaların yaşları, MS tanı süreleri, daha önce kullandıkları immun modülatör tedaviler kaydedildi. Ocrelizumab öncesi T2, FLAIR sekans MR lezyon sayısı, EDSS ve ocrelizumab aldıktan bir yıl sonraki T2, FLAIR sekans MR lezyon sayısı, EDSS kaydedildi. Hastaların bir yıllık takibi sonrasında atak olmaması, MRG’da lezyon sayısında artış olmaması ve EDSS’de ilerleme olmaması NEDA 3 olarak kabul edildi.
Bulgular: Bu çalışmadaki olgularımız 30 MS hastasını içermektedir. Hastaların %26,7’si relapsing remitting MS (RRMS), %26.7 primer progresif MS (PPMS) ve %46.7’si sekonder progresif MS (SPMS) hastasıydı. Olguların %10’u naif hasta idi ve %90’ı daha önce bir veya iki DMT ile tedavi edilmişti. RRMS hasta grubunda %87.5 atak görülmedi. SPMS hasta grubunda ataklı seyreden olgularda ocrelizumab sonrası ataklar gözlenmedi. Çalışmamızda yeni T2 lezyon geliştirmeyen ve lezyonlarda kaybolma görünen hasta oranı RRMS hasta grubunda %62.5, SPMS hasta grubunda %78.5, PPMS hasta grubunda %75 olarak saptanmıştır. Total hasta grubunda EDSS artışı olmayan hasta oranı %93 (28 hasta) olarak saptanmıştır.
Sonuç: Çalışmamızda ocrelizumabın atak oranlarını azaltarak, EDSS puanlarını koruyarak ve lezyon yükünde artışı önleyerek etkili olduğu saptanmıştır. Bulgularımız gerçek yaşam verileri ile uyumluluk göstermektedir.
References
- Sorensen PS, Blinkenberg M. The potential role for ocrelizumab in the treatment of multiple sclerosis: Current evidence and future prospects. Ther Adv Neurol Disord. 2016;9(1):44–52
- Barkhof F, Kappos L, Wolinsky J. S, Li D. K, Bar-Or A, Hartung H. P Hauser S. L. Onset of clinical and MRI efficacy of ocrelizumab in relapsing multiple sclerosis. Neurology, 2019: 93(19), e1778-e1786
- Rojas JI, Patrucco L, Fruns M, Hornung G, Flores J, Contenttı EC, et al. Real-world experience of ocrelizumab in multiple sclerosis patients in latin america. Arq Neuropsiquiatr. 2021;79(4):305–9
- Ellwardt E, Rolfes L, Klein J, Pape K, Ruck T, Wiendl H, et al. Ocrelizumab initiation in patients with MS: A multicenter observational study. Neurol Neuroimmunol neuroinflammation. 2020;7(4):1–9
- Fernandez-Diaz E, Perez-Vicente JA, Villaverde-Gonzalez R, Berenguer-Ruiz L, Candeliere Merlicco A, Martinez-Navarro ML, et al. Real-world experience of ocrelizumab in multiple sclerosis in a Spanish population. Ann Clin Transl Neurol. 2021;8(2):385–94
- Moss Brandon et al “Real-World Experience with Ocrelizumab (P6.356).” Neurology 90.15 Supplement (2018): P6.356. Web. 01 Sept2022
- Garcia-Cañibano B, Ouanes S, Ganesan GS, Yousuf W, Humos B, Baig T, et al. Real-world experience of ocrelizumab in multiple sclerosis in an Arab population. J Drug Assess [Internet]. 2021;10(1):106–13
- Weinstock-Guttman B, Bermel R, Cutter G, Freedman MS, Leist TP, Ma X, et al. Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous disease-modifying therapy: A nonrandomized controlled trial. Mult Scler J. 2022;28(5):790–800
- Koc E, Saridas F, Ceylan D, Turan O, Ozkaya G. Real-world experience of ocrelizumab in MS in the Turkish population: A singlecenter study . European Journal of Neurology 2022; 29:792
- Bolling J, Vasquez M, Eduardo VSC, Carlson A, Gyang T. Real-world Experience with Ocrelizumab - A Safety Analysis (4199) Neurology Apr 2020;94(15 Supplement):4199
- López Ruiz R, Eichau S, Guerra Hiraldo J. D, Dotor García-Soto J, Ruiz De Arcos M, Ruiz-Peña J. L. Real world data on the use of ocrelizumab. Incidence of lymphopenia, B-cell and immunoglobulins evolution. Multiple Sclerosis Journal 2021;631-631.
Details
| Primary Language | English |
|---|---|
| Subjects | Health Care Administration |
| Journal Section | Araştırma Makaleleri |
| Authors | |
| Early Pub Date | March 28, 2024 |
| Publication Date | March 28, 2024 |
| Submission Date | December 1, 2022 |
| Acceptance Date | January 11, 2023 |
| Published in Issue | Year 2024 Volume: 19 Issue: 1 |
