Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with a suboptimal response to previous disease-modifying therapies (1-year interim results)

paroxysmal neurological changes, and from the authors' knowledge a rare diagnosis of these patients.

doi:10.1016/j.jns.2019.10.1403

WCN19-1883

Journal of the Neurological Sciences 405S (2019) 105066 Poster Session 3

Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with a suboptimal response to previous disease-modifying therapies (1‑year interim results) P. Vermerscha, J.P. Eralinnab, R. Nicholasc, C. Oreja-Guevarad, A. Sivae, B. Van Wijmeerschf_{, H. Wiendl}g_{, R. Buffels}h_{, R. Kuhelj}h_{, W. Wei}h_{, G.}

Comii

a_{University of Lille, Department of Neurology, Lille, France} b_{NEO Research, Department of Neurology, Turku, Finland}

c_{Imperial College Healthcare NHS Trust and Imperial College London,}

Department of Neurology, London, United Kingdom

d

Hospital Clinico San Carlos, Department of Neurology, Madrid, Spain

e_{Istanbul University, Cerrahpasa Faculty of Medicine, Cerrahpasa, Turkey} f_{University Hasselt and Rehabilitation & MS-Centre, Department of}

Neurology, Overpelt, Belgium

g_{University of Münster, Department of Neurology, Münster, Germany} h_{F. Hoffmann-La Roche Ltd, na, Basel, Switzerland}

i

Vita-Salute San Raffaele University, Department of Neurology, Milan, Italy Background

The aim of the prospective, multicentre, single-arm Phase IIIb CASTING study (NCT02861014) is to assess the efficacy/safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS) with a prior suboptimal response to disease-modifying therapy (DMT).

Objective

To report 1-year interim analyses of no evidence of disease activity (NEDA) in CASTING.

Methods

Patients (Expanded Disability Status Scale [EDSS] score ≤4.0; disease duration≤10 years; discontinued prior DMT of ≥6 months’ duration due to suboptimal disease control) received intravenous ocrelizumab 600 mg/24 weeks for 96 weeks. NEDA (absence of: protocol-defined relapses [PDR], 24-week confirmed disability progression [24W-CDP], T1 gadolinium-enhancing or new/enlarging T2 lesions [rebaselined at Week 8]) was assessed every 24 weeks in the modified intent-to-treat population (mITT; patients receiving any dose who discontinued early without a protocol-defined event were imputed as having an event if treatment discontinuation was for lack of efficacy/death; others were excluded).

Results

A total of 680 patients (female, 64%; mean [SD] baseline EDSS score, 2.1 [1.1]; disease duration, 5.0 [2.7] years; pretreated with one DMT, n=411 [60.5%]; pretreated with two DMTs, n=265 [39.5%]) were included in the interim mITT population. At Week 48, most patients had NEDA (n/N=586/674 [86.9%]). Rates of 24W-CDP (4.8%), PDR (4.2%), T1 gadolinium-enhancing (2.8%) and new/ enlarging T2 lesions (6.2%) were low. The adjusted annualised relapse rate was 0.048. Safety outcomes will be reported.

Conclusions

Most patients in CASTING had NEDA. Future CASTING data will describe additional ef_{ficacy/safety results of ocrelizumab treatment} in patients who had ongoing disease activity while receiving another DMT.

doi:10.1016/j.jns.2019.10.1404

WCN19-1884

Journal of the Neurological Sciences 405S (2019) 105067 Poster Session 3

Vitamin 25(OH) D and cognitive function in parkinson’s disease M. Barichellaa_{, C. Bolliri}a_{, G. Pinelli}b_{, L. Iorio}a_{, V. Ferri}a_{, E. Cassani}a_{, A.}

Gianaa_{, S. Caronni}a_{, C. Pusani}a_{, F. Del Sorbo}a_{, R. Cilia}a_{, E. Quacci}a_{, G.}

Riboldazzic_{, S. Lanfranchi}c_{, E. Cereda}d_{, G. Pezzoli}a

a_{Parkinson Institute- ASST G.Pini-CTO, ASST G.Pini-CTO, Milan, Italy} b_{Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del}

Movimento- Ospedale Classificato Moriggia Pelascini- Gravedona, Milan, Italy

c_{U.S. Riabilitazione Parkinson- Fondazione Gaetano e Piera Borghi di}

Brebbia, Fondazione Gaetano e Piera Borghi, Brebbia, Italy

d

Clinical Nutrition and Dietetics Unit- Fondazione IRCCS Policlinico San Matteo- Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy Objective

The role of vitamin D is gaining attention in neurodegenerative diseases, as low serum concentrations have been consistently found in both Alzheimer’s and Parkinson’s disease (PD). This study aims to correlate 25(OH) D plasma levels with global cognitive function and severity of motor function in PD.

Methods

350 patients with idiopathic PD (66% male, mean age 70.5 yr (range 60-87), mean disease duration 9.9±5.7 yr) were consecu-tively recruited at a tertiary referral clinic during an 8-month period. We correlated plasma 25(OH) D levels with demographic and clinical data, including PD severity (Hoehn & Yahr stage) and global cognitive function (Mini Mental State Examination, MMSE) . In addition, Plasma 25(OH) D levels were correlated with sun exposure (hours/day).

Results

Overall, PD patients showed 25(OH) D deficiency (mean level 17.1 ± 8.34 ng/ml). Using simple linear correlation analysis, we found a direct association between 25(OH) D and MMSE score (p=0.03) and an inverse association between 25(OH) D and age (pb0.01) and the Hoehn & Yahr stage (p=0.01). Plasma 25(OH) D levels positively correlated with solar exposure (p = 0.04). Conclusion

In a large PD cohort, low 25(OH) D levels correlated with older age and with worse global cognitive function and disease severity. Daily time of sun exposure greatly increased 25(OH) D levels. We strongly recommend screening PD patients for 25(OH) D plasma levels and -in case of deficiency- ensuring oral supplementation to reduce the risk of cognitive dysfunction and motor disability. doi:10.1016/j.jns.2019.10.1405

Abstracts / Journal of the Neurological Sciences 405S (2019) 116542 310