Ocrelizumab In Multiple Sclerosis Research Articles

Extended interval dosing with ocrelizumab in multiple sclerosis

Background: This study investigates clinical and biomarker differences between standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab therapy in multiple sclerosis (MS). Methods: This is a prospective, double-arm, open-label, multi-center study in Denmark. Participants diagnosed with MS on ocrelizumab therapy >12 months were included (n = 184). Clinical, radiological, and blood-based biomarker outcomes were evaluated. MRI disease activity, relapses, worsening of neurostatus, and No Evidence of Disease Activity-3 (NEDA-3) were used as a combined endpoint. Results: Out of 184 participants, 107 participants received EID (58.2%), whereas 77 participants received SID (41.8%). The average extension was 9 weeks with a maximum of 78 weeks. When comparing EID to SID, we found higher levels of B-cells, lower serum concentrations of ocrelizumab, and similar levels of age-adjusted NFL and GFAP in the two groups. No difference in NEDA-3 between EID and SID was demonstrated (hazard ratio: 1.174, p = 0.69). Higher levels of NFL were identified in participants with disease activity. Body mass index correlated with levels of ocrelizumab and B-cells. Conclusion: Extending one treatment interval of ocrelizumab on average 9 weeks and up to 78 weeks did not result in clinical, radiological, or biomarker evidence of worsening compared with SID.

Real world study of ocrelizumab in multiple sclerosis: Kuwait experience.

Ocrelizumab is a humanized anti-CD20 antibody that has been approved for the treatment of patients with multiple sclerosis (MS). Real-world data in the Middle East is very limited. To describe the effectiveness and safety of ocrelizumab treatment in MS patients in a real clinical setting. This is an observational, registry-based study. MS patients who were treated with ocrelizumab and completed at least one-year follow-up post-treatment were included. Baseline clinical and radiological characteristics were collected before ocrelizumab initiation. The relapse rate, disability measures, magnetic resonance image (MRI) activity (new T2 lesions and/or GD+ enhancing T1 lesions), and adverse events (AE) at the last follow-up visits were assessed. Data from 447 patients were analyzed, of which 260 (58.2%) were females. The mean age and mean disease duration were 37.39±11.61 and 9.38±7.57 years respectively. Most of the cohort was of a relapsing form (74.3%; n=332), whereas active secondary and primary progressive forms represented 15.4% (n=69) and 10.3% (n=46) respectively. In the relapsing cohort, Ocrelizumab was prescribed in 162 (48.8%) patients due to highly active disease, and in 99 (29.8%) patients due to disease breakthrough while on prior therapies. In the last follow-up visits, most of the relapsing cohort was relapse-free (95.8% vs. 27.4%; p <0.001), had no evidence of MRI activity (3.6% vs. 67.5%; p <0.001) while EDSS score was stable (1.80+1.22vs. 1.87+1.16; p < 0.104) when compared to baseline. NEDA-3 was achieved in 302 (91%) of RRMS patients. Confirmed disability progression was 27.5% and 23.9% in SPMS and PPMS respectively. Adverse events were observed in 139 (31.1%); infusion reactions and infections represented the most. This study showed that ocrelizumab is an effective and safe treatment for MS patients in a real clinical setting similar to what was observed in clinical trials.

FRI432 An Interesting Case Of Primary Hypogonadism In A Patient With Multiple Sclerosis

Abstract Disclosure: S. Ahsun: None. P. Lekprasert: None. K.K. Win: None. Introduction: As per the recent data there is an association between low levels of testosterone in men and the risk for multiple sclerosis (MS). Most recent practice involves checking testosterone levels for male patients with newly developed MS and treating with testosterone supplementation if levels are low. CASE PRESENTATION: A 65-year-old male with medical history of multiple sclerosis, prediabetes, hypogonadism, squamous cell carcinoma of left ear, thyroid cancer (unknown type) status post total thyroidectomy and radioiodine therapy; presented to our endocrine office for an initial visit. Patient had been following with Endocrinologist at different state in the past and did not have much of his prior records since that practice closed. He has been on 150 mcg of levothyroxine and his TSH was stable at 1.2 (0.4-4.5 mIU/L). He also had a history of hypogonadism and had been on testosterone supplementation since the age around 50. Patient did not know the underlying cause for his hypogonadism. He has 3 biological children and the youngest one is 26 years old. He had been off of testosterone therapy for 3 months prior to our initial visit. We did some workup which showed total testosterone level of &amp;lt;20 (250-1100 ng/dL). Free testosterone 2.2 (46-224 pg/mL). FSH and LH levels were elevated at 27.1 (1.6-8 mIU/mL) and 17.3 (1.6-15.2 mIU/mL). Prolactin level was 5.1 (5.2-26.5) ng/mL. These labs were consistent with Primary hypogonadism. Repeat testing was done and the patient had redemonstration of very low testosterone levels. Further checking of the karyotype analysis revealed normal male karyotype testing. His physical exam showed normal sized testicles at 20 cc and no gynecomastia. Body hair distribution was normal but there was decreased shaving frequency with decreased muscle strength. Patient never had any chemotherapy or the radiation therapy to the pelvic area. No known history of chronic infection or trauma. Currently, he is on Ocrelizumab for Multiple Sclerosis. His testosterone level is now in the normal range with the testosterone therapy after the work up. CONCLUSION: As per the above case, our patient has an interesting presentation of primary hypogonadism with multiple sclerosis. He has no known reason for his primary testicular failure. We know that testosterone deficiency has been linked to development of MS and MS can lead to secondary hypogonadism. But Primary hypogonadism has not yet been seen with MS although autoimmunity can be postulated to lead to primary testicular failure in these patients, but more studies and investigation will need to be done to establish this cause and effect relationship. REFERENCE: Chitnis T. The role of testosterone in MS risk and course. Mult Scler. 2018 Jan;24(1):36-41. doi: 10.1177/1352458517737395. PMID: 29307293 Presentation: Friday, June 16, 2023

Impact of extended interval dosing of ocrelizumab on immunoglobulin levels in multiple sclerosis

Long-term B cell depletion with ocrelizumab in multiple sclerosis (MS) is associated with severe side effects such as hypogammaglobulinemia and infections. Our study therefore aimed to assess immunoglobulin levels under treatment with ocrelizumab and implement an extended interval dosing (EID) scheme. Immunoglobulin levels of 51 patients with ≥24months of treatment with ocrelizumab were analyzed. After ≥4 treatment cycles, patients chose to either continue on the standard interval dosing (SID) regimen (n= 14) or, in the case of clinically and radiologically stable disease, switch to B cell-adapted EID (n= 12, next dose at CD19+ Bcells >1% of peripheral blood lymphocytes). Levels of immunoglobulin M (IgM) declined rapidly under ocrelizumab treatment. Risk factors for IgM and IgA hypogammaglobulinemia were lower levels at baseline and more previous disease-modifying therapies. B cell-adapted EID of ocrelizumab increased the mean time until next infusion from 27.3 to 46.1weeks. Ig levels declined significantly in the SID group over 12months but not in the EID group. Previously stable patients remained stable under EID as measured by expanded disability status scale (EDSS), neurofilament light chain, timed 25-foot walk (T25-FW), 9-hole peg test (9-HPT), symbol digit modalities test (SDMT), and multiple sclerosis impact scale (MSIS-29). In our pilot study, B cell-adapted EID of ocrelizumab prevented the decline of Ig levels without affecting disease activity in previously stable patients with MS. Based on these findings, we propose a new algorithm for long-term ocrelizumab treatment. This study was supported by the Deutsche Forschungsgemeinschaft (SFB CRC-TR-128, SFB 1080, and SFB CRC-1292) and the Hertie Foundation.

Hailey Hailey Disease (Benign Familial Pemphigus) responsive to treatment with ocrelizumab for multiple sclerosis.

Benign familial pemphigus, also known as Hailey–Hailey disease (HHD), is a rare autosomal-dominant genetic skin disorder characterized by symmetrical, well-demarcated, erythematous, painful erosive and crusted plaques in the intertrigous regions. Treatment options are limited and aimed at control and limiting complications. Ocrelizumab, an anti-CD20 antibody, was given to treat our patient’s multiple sclerosis, and incidentally found to have cleared her HHD, thus offering a potential effective treatment option.

Effectiveness of ocrelizumab on clinical and MRI outcome measures in multiple sclerosis across black and white cohorts: A single-center retrospective study.

To examine differences in the therapeutic response to ocrelizumab in multiple sclerosis (MS) patients who self-identified as either White or Black, assessed longitudinally by expanded disability status scale (EDSS) progression and MRI brain volume loss. MS subjects treated with ocrelizumab were retrospectively identified. Clinical data were available for 229 subjects (White 146; Black 83) and MRI data from for 48 subjects (White 31; Black 17). Outcome measures were changes in the EDSS and brain volume over time. EDSS were analyzed as raw scores, ambulatory (EDSS <5.0) vs. ambulatory with assistance (5.5 ≤ EDSS ≤ 6.5) status, and EDSS severity (< 3.0, 3.0-5.0, and > 5.5 ≤ 6.5). General linear mixed model was used for statistical analysis. FreeSurfer was used for volumetric analysis. The Black cohort had overrepresentation of females (78% vs. 62%, p=0.013), lower age (median, 45 (IQR 39-51) vs. 49 (38-58), p=0.08), lower Vitamin D levels (33 (21-45) vs. 40 (29-52), p=0.002), and higher EDSS (4 (2-6) vs. 2.5 (1-6), p=0.019). There was no progression of EDSS scores over the 2-year observation period. The covariates with significant influence on the baseline EDSS scores were older age, race, longer disease duration, prior MS treatment, and lower vitamin D levels. No differences were observed between the racial groups over time in the cortical, thalamic, caudate, putamen, and brainstem gray matter volumes nor in the cortical thickness or total lesion volume. In this real-world clinical and radiological study, ocrelizumab treatment was highly effective in stabilizing clinical and MRI measures of disease progression in Blacks and Whites, despite higher baseline disability in the Black cohort.

034 Updated safety analysis of ocrelizumab in multiple sclerosis

BackgroundOngoing safety reporting is crucial to understanding the long-term benefit-risk profile of ocrelizumab in multiple sclerosis (MS). Safety/efficacy of ocrelizumab have been characterised in Phase II (NCT00676715) and III (NCT01247324/NCT01412333/NCT01194570) trials in relapsing-remitting MS, relapsing MS (RMS) and primary progressive MS (PPMS). Here, we report safety evaluations from ocrelizumab clinical trials and open-label extensions up to January 2019, and selected post-marketing data.MethodsSafety outcomes are reported for the ocrelizumab all-exposure population in Phase II/III and ongoing Phase IIIb trials. To account for different exposure lengths, rates per 100 patient years (PY) are presented.ResultsIn clinical trials, 4,611 patients with MS received ocrelizumab (14,329 PY exposure). Reported rates per 100 PY (95% confidence interval) were: adverse events (AEs), 252 (249–254); serious AEs, 7.33(6.89–7.79); infections, 76.7 (75.3–78.2); serious infections, 1.99 (1.77–2.23); malignancies, 0.46 (0.35–0.58); and AEs leading to discontinuation, 1.08 (0.92–1.27). Updated ocrelizumab all-exposure population data and selected post-marketing data will be presented.ConclusionsReported event rates in the ocrelizumab all-exposure clinical trial population and post-mar- keting settings remain generally consistent with the controlled treatment period in RMS/PPMS populations. Regular reporting of long-term safety data will continue.k.schmierer@qmul.ac.uk

Ocrelizumab for multiple sclerosis.

Ocrelizumab is a humanised anti-CD20 monoclonal antibody developed for the treatment of multiple sclerosis (MS). It was approved by the Food and Drug Administration (FDA) in March 2017 for using in adults with relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). Ocrelizumab is the only disease-modifying therapy (DMT) approved for PPMS. In November 2017, the European Medicines Agency (EMA) also approved ocrelizumab as the first drug for people with early PPMS. Therefore, it is important to evaluate the benefits, harms, and tolerability of ocrelizumab in people with MS. To assess the benefits, harms, and tolerability of ocrelizumab in people with RRMS and PPMS. We searched MEDLINE, Embase, CENTRAL, and two trials registers on 8 October 2021. We screened reference lists, contacted experts, and contacted the main authors of studies. All randomised controlled trials (RCTs) involving adults diagnosed with RRMS or PPMS according to the McDonald criteria, comparing ocrelizumab alone or associated with other medications, at the approved dose of 600 mg every 24 weeks for any duration, versus placebo or any other active drug therapy. We used standard methodological procedures expected by Cochrane. Four RCTs met our selection criteria. The overall population included 2551 participants; 1370 treated with ocrelizumab 600 mg and 1181 controls. Among the controls, 298 participants received placebo and 883 received interferon beta-1a. The treatment duration was 24 weeks in one study, 96 weeks in two studies, and at least 120 weeks in one study. One study was at high risk of allocation concealment and blinding of participants and personnel; all four studies were at high risk of bias for incomplete outcome data. For RRMS, compared with interferon beta-1a, ocrelizumab was associated with: 1. lower relapse rate (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.52 to 0.73; 2 studies, 1656 participants; moderate-certainty evidence); 2. a lower number of participants with disability progression (hazard ratio (HR) 0.60, 95% CI 0.43 to 0.84; 2 studies, 1656 participants; low-certainty evidence); 3. little to no difference in the number of participants with any adverse event (RR 1.00, 95% CI 0.96 to 1.04; 2 studies, 1651 participants; moderate-certainty evidence); 4. little to no difference in the number of participants with any serious adverse event (RR 0.79, 95% CI 0.57 to 1.11; 2 studies, 1651 participants; low-certainty evidence); 5. a lower number of participants experiencing treatment discontinuation caused by adverse events (RR 0.58, 95% CI 0.37 to 0.91; 2 studies, 1651 participants; low-certainty evidence); 6. a lower number of participants with gadolinium-enhancing T1 lesions on magnetic resonance imaging (MRI) (RR 0.27, 95% CI 0.22 to 0.35; 2 studies, 1656 participants; low-certainty evidence); 7. a lower number of participants with new or enlarging T2-hyperintense lesions on MRI (RR 0.63, 95% CI 0.57 to 0.69; 2 studies, 1656 participants; low-certainty evidence) at 96 weeks. For PPMS, compared with placebo, ocrelizumab was associated with: 1. a lower number of participants with disability progression (HR 0.75, 95% CI 0.58 to 0.98; 1 study, 731 participants; low-certainty evidence); 2. a higher number of participants with any adverse events (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 725 participants; moderate-certainty evidence); 3. little to no difference in the number of participants with any serious adverse event (RR 0.92, 95% CI 0.68 to 1.23; 1 study, 725 participants; low-certainty evidence); 4. little to no difference in the number of participants experiencing treatment discontinuation caused by adverse events (RR 1.23, 95% CI 0.55 to 2.75; 1 study, 725 participants; low-certainty evidence) for at least 120 weeks. There were no data for number of participants with gadolinium-enhancing T1 lesions on MRI and number of participants with new or enlarging T2-hyperintense lesions on MRI. For people with RRMS, ocrelizumab probably results in a large reduction in relapse rate and little to no difference in adverse events when compared with interferon beta-1a at 96 weeks (moderate-certainty evidence). Ocrelizumab may result in a large reduction in disability progression, treatment discontinuation caused by adverse events, number of participants with gadolinium-enhancing T1 lesions on MRI, and number of participants with new or enlarging T2-hyperintense lesions on MRI, and may result in little to no difference in serious adverse events (low-certainty evidence). For people with PPMS, ocrelizumab probably results in a higher rate of adverse events when compared with placebo for at least 120 weeks (moderate-certainty evidence). Ocrelizumab may result in a reduction in disability progression and little to no difference in serious adverse events and treatment discontinuation caused by adverse events (low-certainty evidence). Ocrelizumab was well tolerated clinically; the most common adverse events were infusion-related reactions and nasopharyngitis, and urinary tract and upper respiratory tract infections.

Vulvovaginal Pyoderma Gangrenosum in a Patient Treated With Ocrelizumab for Multiple Sclerosis.

Vulvovaginal Pyoderma Gangrenosum in a Patient Treated With Ocrelizumab for Multiple Sclerosis.

IBD MIMICS PRESENTED AT IBD LIVE: WHEN IT IS NOT INFLAMMATORY BOWEL DISEASE

Abstract BACKGROUND A group of Inflammatory Bowel Disease (IBD) specialists have been utilizing a weekly live video conference “IBD Live” to discuss multidisciplinary management of challenging cases. Since 2009 the conference has featured robust interactive case discussions among 150-200 gastroenterologists and colorectal surgeons from multiple academic institutions. Although the majority of cases presented are IBD, there have been a number of cases where IBD was not the ultimate diagnosis. Hence, we sought to characterize these “IBD mimics” to provide a structure for differential diagnosis. METHODS All 106 hours of case conferences recorded and archived between May 2018 and June 2021 were reviewed. A total of 183 of the 215 cases discussed had an IBD diagnosis including 124 Crohn’s disease (CD), 54 ulcerative colitis (UC) and 5 IBD unclassified. RESULTS Many of the remaining 32 (14.9%) cases (Table 1) were referred to a specialist with a prior diagnosis of IBD. There were 10 cases of colonic inflammation initially diagnosed as UC. Etiologies included drug-induced colitis secondary to checkpoint inhibitors for cancers, ocrelizumab for multiple sclerosis, and nintedanib for pulmonary fibrosis. There were cases of ischemic colitis, idiopathic myointimal hyperplasia of mesenteric veins, segmental colitis associated with diverticulosis, and diversion colitis. There were 8 cases of systemic diseases, diagnosed as Common Variable Immunodeficiency, sarcoidosis and vasculitis, including cases of Henoch–Schönlein purpura and CTLA4 haploinsufficiency with autoimmune infiltrates. There were 5 cases of ileal disorders, ultimately diagnosed as lymphoma, tuberculosis, Meckel’s diverticulum, and appendiceal carcinoid all previously thought to be CD. There were small bowel mucosal disorders including collagenous sprue and autoimmune enteropathy, and 2 polyposis cases secondary to Cronkhite-Canada and juvenile polyposis syndromes. There were also cases thought to be penetrating complications of CD, including a case of abdominal actinomyces infection. Finally, there were 3 cases where no consensus diagnosis was made, with broad differential diagnoses including cryptogenic multifocal ulcerous stenosis enteritis. CONCLUSIONS IBD mimics were found in 15% of cases presented at a global IBD webinar in a 3-year period. Clinicians should have a high level of suspicion and actively pursue alternative etiologies when patients do not respond as anticipated to IBD therapy and/or when the disease characteristics are not completely consistent with IBD. These non-IBD diagnoses will lead to a significant change in medical, surgical and pharmacological treatment approaches, which will impact total cost, unplanned care and quality. Our IBD Live conference has positively impacted the care of our patients, and magnified the importance of considering a broad differential for IBD "mimics."

Pregnancy outcome following exposure to ocrelizumab in multiple sclerosis.

BackgroundOcrelizumab is a monoclonal antibody targeting CD20-expressing B cells used in the treatment of multiple sclerosis (MS). Currently, there is limited safety data in pregnancy.ObjectivesTo report the pregnancy outcome following exposure to ocrelizumab in MS.MethodsWe retrospectively identified 14 pregnancies of 12 MS patients who had been exposed to ocrelizumab within 6 months prior to conception or during pregnancy from a specialty clinic in Western Australia.Results13 of 14 pregnancies resulted in live births. One pregnancy was electively terminated following detection of a chromosomal defect. One pregnancy was complicated with placental insufficiency and the infant developed hyaline membrane disease which was complicated by sepsis. There were no observed major congenital anomalies, preterm births, stillbirths or low birthweight. We did not observe any serious maternal infections. All patients were relapse-free despite a mean ocrelizumab-free interval of 65.1 weeks.ConclusionsWe did not identify any major safety signals among the patients who received ocrelizumab prior to conception or during the first trimester of pregnancy. Our patients appeared to have a stable disease course despite a prolonged period of treatment interruption during pregnancy.

Comparative effectiveness of natalizumab versus ocrelizumab in multiple sclerosis: a real-world propensity score-matched study.

For treatment of relapsing-remitting multiple sclerosis (RRMS), a broad range of disease-modifying therapies (DMT) is available. However, few comparative effectiveness studies between different drugs have been performed. This study aimed to compare the efficacy and treatment continuation of natalizumab and ocrelizumab in a real-world cohort of patients with relapsing-remitting multiple sclerosis (RRMS) from two German university hospitals. We performed a retrospective analysis of RRMS patients who initiated treatment with natalizumab or ocrelizumab between January 2016 and April 2019 at the German university hospitals of Mainz and Düsseldorf. Bayesian propensity score matching was conducted to correct for differences in baseline characteristics. Our primary outcome was no evidence of disease activity [NEDA-3: no relapses, no confirmed disability progression, and no magnetic resonance imaging (MRI) activity] and its subcomponents. Secondary outcomes included measurement of neurofilament light chain (NfL) in serum, analysis of premature discontinuation, and evidence of rebound activity in patients switching from natalizumab to ocrelizumab. We identified 63 patients starting treatment with natalizumab and 76 patients starting with ocrelizumab. Binary logistic regression showed that treatment with natalizumab or a higher number of relapses in the previous year were independently associated with a higher risk for relapses. Patients receiving natalizumab had a higher probability of premature discontinuation of therapy (p = 0.002). After propensity score matching of the two treatment arms, 55 patients remained per group. NEDA-3 after 30 months of follow-up was reached by 53.1% in the ocrelizumab group and 36.1% in the natalizumab group (p = 0.177). Ocrelizumab was superior to natalizumab concerning the occurrence of relapses in log-rank test (p = 0.019). NfL levels in serum were low under both treatments. Patients who switched from natalizumab to ocrelizumab showed no increased rebound activity. This study provides class IV evidence that treatment of RRMS patients with ocrelizumab and natalizumab show comparable effectiveness in combined endpoints, while ocrelizumab might be more effective in preventing the occurrence of relapses.

Robust T-Cell Responses in Anti-CD20-Treated Patients Following COVID-19 Vaccination: A Prospective Cohort Study.

BackgroundPatients treated with anti-CD20 therapy are particularly at risk of developing severe COVID-19, however little is known regarding COVID-19 vaccine effectiveness in this population.MethodsThis prospective observational cohort study assesses humoral and T-cell responses after vaccination with 2 doses of mRNA-based COVID-19 vaccines in patients treated with rituximab for rheumatic diseases or ocrelizumab for multiple sclerosis (n=37), compared to immunocompetent individuals (n=22).ResultsSARS-CoV-2-specific antibodies were detectable in only 69.4% of patients and at levels that were significantly lower compared to controls who all seroconverted. In contrast to antibodies, Spike (S)-specific CD4+ T cells were equally detected in immunocompetent and anti-CD20 treated patients (85-90%) and mostly of a Th1 phenotype. Response rates of S-specific CD8 + T cells were higher in ocrelizumab (96.2%) and rituximab-treated patients (81.8%) as compared to controls (66.7%). S-specific CD4 + and CD8 + T cells were polyfunctional but expressed more activation markers in patients than in controls. During follow-up, three MS patients without SARS-CoV-2-specific antibody response had a mild breakthrough infection. One of them had no detectable S-specific T cells after vaccination.ConclusionsOur study suggests that patients on anti-CD20 treatment are able to mount potent T-cell responses to mRNA COVID-19 vaccines, despite impaired humoral responses. This could play an important role in the reduction of complications of severe COVID-19.

Real-world experience of ocrelizumab in multiple sclerosis in an Arab population

Objective Pivotal clinical trials revealed good clinical efficiency of ocrelizumab while having a good safety profile in the management of multiple sclerosis (MS). However, real-world data of ocrelizumab in daily clinical practice remain scarce. The aim of this study was to evaluate the preliminary safety profile and effectiveness of ocrelizumab treatment for MS in an Arab population in a real-world clinical setting. Methods In this retrospective single-center observational study in Qatar, we reviewed the medical records and analyzed the clinical and MRI data of all patients with relapsing-remitting MS (RRMS) and active secondary progressive MS (aSPMS)—between October 2017 through December 2020—who had received at least one infusion of ocrelizumab (Q-OCRE). Results A total of 60 MS patients were included (57 with RRMS, three SPMS). The Median follow-up period was 19 months (range, 1–32). The most common reason for switching to ocrelizumab was increased disease activity and three-quarters of the patients were on a previous disease-modifying drug (DMD). No evidence of disease activity (NEDA) status at year 1 was achieved in 73% of the cohort. Mild infusion-related reactions (IRR) and infections were reported (mainly upper respiratory tract infections followed by urinary tract infection) with a declining percentage over the follow-up applications. No severe side effects were observed. Conclusion Our real-world experience confirms good efficacy, tolerability, and safety of ocrelizumab in our Arab population.

Long-Term Safety of Ocrelizumab in Multiple Sclerosis

Ocrelizumab was approved for relapsing multiple sclerosis (RMS) and primary progressive (PP) MS in 2017. Investigators have now evaluated safety from

Recurrent MRI Activity After Treatment with Ocrelizumab for Multiple Sclerosis (2533)

Recurrent MRI Activity After Treatment with Ocrelizumab for Multiple Sclerosis (2533)

Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients With Relapsing and Primary Progressive Multiple Sclerosis (1812)

Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients With Relapsing and Primary Progressive Multiple Sclerosis (1812)

Ocrelizumab in Multiple Sclerosis: A Real-World Study From Spain.

Objectives: The aim of this study was to describe the tolerability, safety, and effectiveness of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting.Methods: In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. Patients involved in any ocrelizumab trial and those patients with a follow-up shorter than 6 months were excluded.Results: The cohort included 70 patients (42 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients' mean age was 47.1 years in the PPMS group and 39.2 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 13.6 months. The median number of treatment cycles was three. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 57% of the patients; by the first MRI control at 4–6 months, all patients except one were free of T1 Gd-enhancing lesions (69/70, 98.6% P < 0.001). The proportion of patients with NEDA was 94% in the group of RMS patients who were followed for at least 1 year. Ocrelizumab was generally well-tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious.Conclusions: Our real-world study supports the tolerability, safety, and effectiveness of ocrelizumab in clinical practice.

Real-world experience of ocrelizumab in multiple sclerosis in a Spanish population.

ObjectivePivotal trial have shown that patients with multiple sclerosis (MS) receiving ocrelizumab had better outcomes. However, data on ocrelizumab in clinical practice are limited. The aim of this study was to evaluate the preliminary safety profile and effectiveness of ocrelizumab treatment for multiple sclerosis (MS) in a real‐world clinical setting.MethodsWe conducted a retrospective study including consecutive patients from nine public hospitals in south‐eastern Spain who received ocrelizumab after it was approved.ResultsA total of 228 MS patients were included (144 with relapsing–remitting MS [RRMS], 25 secondary progressive MS [SPMS], and 59 primary progressive MS [PPMS]). Median follow‐up period was 12 months (range, 1‐32). No evidence of disease activity (NEDA) status at year 1 was achieved in 91.2% of the relapsing MS (RMS) population, while disability progression was detected in 37.5% of the PPMS patients (median follow‐up period, 19 months). The most common adverse events reported were infusion‐related reactions and infections, with the most common infections being urinary tract infections followed by upper respiratory infections and COVID‐19.InterpretationThe preliminary results in our real‐world setting show that ocrelizumab presented excellent results in suppressing disease activity with a favorable and consistent safety profile.

Socioeconomic benefits of ocrelizumab for multiple sclerosis

Socioeconomic benefits of ocrelizumab for multiple sclerosis