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

BACKGROUND: 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. OBJECTIVES: To describe the effectiveness and safety of ocrelizumab treatment in MS patients in a real clinical setting. METHODS: 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. RESULTS: 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+1.22 vs. 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. CONCLUSION: 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.

A prospective observational longitudinal study with a two-year follow-up of multiple sclerosis patients on Cladribine.

BACKGROUND: Cladribine was approved for the treatment of multiple sclerosis (MS). Real-world data is very limited. OBJECTIVES: To study the effectiveness and the safety of Cladribine treatment in only one group of MS patients after treatment with Cladribine for two years. METHODS: This observational, longitudinal prospective study. Eligible subjects were relapsing remitting MS patients who had at least two-year follow-up after Cladribine treatment. The primary endpoint was the proportion of relapse free patients. Secondary endpoints were ARR, change in EDSS scores, the proportion of patients with CDP, MRI activity, and NEDA-3 status, also the rate of occurrence of AEs. Patients were assessed for primary and secondary endpoints at the end of two years of follow-up. RESULTS: Of a total of seventy-two patients, 59 (81.9 %) were females, mean age of 36.32 + 10.06 years old, mean disease duration 7.21 + 6.19. Most patients (n = 32; 44.4 %) were naïve to any treatment. Forty patients (55.6 %) completed two courses of treatment. The primary endpoint showed that most of our cohort was relapse free (85 % versus 25 %; P < 0.001), Secondary endpoints showed that ARR was significantly reduced 0.15 + 0.36 versus 0.85 + 0.53; P < 0.01). Most of the cohort 90 % have no progression of disability. Few subjects had new T2 lesions (7.5 % versus 70.8 %; P < 0.001 and gadolinium enhancement 5 % versus 66.7 %; P < 0.001) in MRI compared to baseline. No evidence of disease activity 3 (NEDA-3) was achieved in 30 (75 %) patients. It was achieved in 87.5 % of naive patients versus 66.7 % in patients who received prior disease modification drugs before Cladribine initiation. Infections 6 (n = 6; 8.4 %) lymphocytopenia (n = 3; 4.2 %), and elevated liver enzymes (n = 1; 1.4 %) were reported. CONCLUSION: Cladribine treatment reduced significantly relapse rate and MRI activity. It was safe and tolerable. Early initiation of cladribine is associated with favorable outcomes.

A real-life study of alemtuzumab in persons with multiple sclerosis: Kuwait's experience.

BACKGROUND: Alemtuzumab, a humanized anti-CD52 monoclonal antibody, has been approved as a treatment in persons with active relapsing-remitting multiple sclerosis (RRMS). Real-world data in middle east is very limited. We aimed to evaluate the effectiveness and safety of alemtuzumab in a real-world clinical setting. METHODS: This observational, registry based study assessed persons with multiple sclerosis (PwMS) who were treated with alemtuzumab and completed at least follow up one year after second course. Baseline clinical and radiological characteristics within one year prior to alemtuzumab initiation were collected. The relapse rate, disability measures, radiological activity and adverse events at last follow-up visits were assessed. RESULTS: Data of seventy-three persons with multiple sclerosis (MS) was analyzed, of which 53 (72.6%) were females. Mean age and mean disease duration were 34.25 ± 7.62 and 9.23 ± 6.20 years respectively. Alemtuzumab was started in 32 (43.8%) naïve patients due to highly active disease and in 25 (34.2%) (PwMS) who were on prior therapies and  in 16 (22%) patients due to adverse events on prior medications. Mean follow-up period was 4 ± 1.67 years. In the last follow-up visits, most of our cohort was relapse free (79.5% vs. 17.8%; p < 0.001) compared to baseline before alemtuzumab treatment while mean EDSS score was reduced (2.21 ± 2.15 vs. 2.41 ± 1.85; p < 0.059). The proportion of PwMS who had MRI activity (new T2/ Gd-enhancing) lesions were significantly reduced compared to baseline (15.1% vs. 82.2%; p < 0.001). NEDA-3 was achieved in 57.5% of (PwMS). NEDA-3 was significantly better in naïve patients (78% versus. 41.5%; p < 0.002) and in patients with disease duration < 5 years, (82.6% v 43.2%; p < 0.002). Several adverse events such as infusion reactions (75.3%), autoimmune thyroiditis (16.4%) and glomerulonephritis (2.7%) were reported. CONCLUSION: The effectiveness and safety profile of alemtuzumab in this cohort were consistent with data of clinical trials. Early initiation of Alemtuzumab is associated with favorable outcome.

Complications Post Abdominoplasty After Surgical Versus Non-surgical Massive Weight Loss: a Comparative Study.

PURPOSE: This study aims to investigate the rate of short- and long-term complications as well as the need for operative revisions after abdominoplasty for patients following surgical versus non-surgical weight loss methods. METHODS: This is a retrospective chart review that enrolled consecutive patients undergoing abdominoplasty across a 5-year period, aged 18 years and above, opting for abdominoplasty after weight loss achieved through bariatric surgery or diet and exercise alone. RESULTS: A total of 364 patients lost weight through bariatric surgery and 106 by diet and exercise alone. There were no significant differences in comorbidity status, but past body mass index (BMI) was higher for the surgical weight loss (SW) group (47.6 ± 10.2 and 40.4 ± 8.6, respectively; p value < 0.0001). Percent excess weight loss (EWL) was 68 ± 14.5 for the SW group and 55.7 ± 19.4 for the NSW group, p value < 0.0001. Pre- and postoperative blood hemoglobin levels were significantly lower in the SW group (p < 0.05). Neither short-term complications (thromboembolic events, wound complications, or infections) nor long-term complications (umbilical deformity, delayed wound healing, or infection) and operative revisions were significantly different across both groups (p > .05). CONCLUSION: Bariatric surgery does not increase the risk of short- or long-term complications or the need for operative revision after abdominoplasty.

COVID-19 vaccination in people with multiple sclerosis, real-life experience.

BACKGROUND: Vaccination against the severe acute respiratory syndrome coronavirus type-2 (SARS-CoV-2) virus is recommended in multiple sclerosis (MS) to reduce the risk of complications from Coronavirus disease 2019 (COVID-19) infection. These vaccines were not investigated in people with MS (PWMS). OBJECTIVE: This study aimed to report the short-term safety of the COVID-19 vaccines among PWMS. METHODS: Pfizer-BioNTech mRNA (BNT162b2) vaccine and Oxford-Astra Zenecaa chimpanzee adenovirus-vectored (ChAdOx1 nCoV-19) vaccine have been approved to be used in Kuwait since December 2021. PWMS registered in Kuwait national registry were contacted by phone, WhatsApp, or through face-to-face interviews and were invited to complete our questionnaire. Demographic, clinical data, symptoms following the vaccine, worsening of pre-existing MS symptoms, and occurrence of relapse were recorded. RESULTS: Of the 820 PWMS, 647 completed the questionnaire. Between January 2021 and 31 August 2021, 383 (59.28%) PWMS received at least one dose of the approved vaccinations versus 63.4% of the general population on the same date. Their mean age was 36.82 + 8.80, and most of them, 247 (64.3%), were females. A total of 356 vaccinated cohorts (92.6%) were treated with disease-modifying therapies. Adverse events were reported by 261 (68.15%) subjects. One case of COVID-19 infection was encountered after the first dose of the BNT162b2 vaccine. Twenty-one (5.48%) cases reported worsening of pre-existing MS symptoms after the vaccine. Five patients (1.31%) reported relapse after the COVID-19 vaccine. The most common adverse events of the COVID-19 vaccine were pain at the injection site, fatigue, low-grade fever, and body ache; and resolved within one week. There was no significant association between use of disease modifying therapy (DMT) and COVID-19 vaccine adverse events. CONCLUSION: BNT162b2 and ChAdOx1 nCoV-19 are safe for PWMS. No increased risk of relapse activity or worsening of pre-existing MS symptoms.