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Trigeminal neuralgia and its management

2007; BMJ; Volume: 334; Issue: 7586 Linguagem: Inglês

10.1136/bmj.39085.614792.be

0959-8138

Luke Bennetto, Nikunj K. Patel, Geraint Fuller,

Facial Nerve Paralysis Treatment and Research

Objective: To assess the efficacy and safety of ocrelizumab over 3 years in patients with relapsing-remitting multiple sclerosis (RRMS) who rolled over from CASTING (NCT02861014) to LIBERTO (NCT03599245). Background: The Phase IIIb CASTING study evaluated the efficacy and safety of ocrelizumab in patients with RRMS with a suboptimal response to ≥6 months treatment with one or two prior disease-modifying therapies (DMTs). LIBERTO is a long-term extension study, in which eligible CASTING patients from participating countries could enroll. Design/Methods: Patients deemed by the treating neurologist as having a positive benefit-risk ratio at the end of the CASTING 96-week treatment period rolled over to LIBERTO and continued intravenous ocrelizumab 600mg every 24 weeks. Efficacy endpoints included no evidence of disease activity (NEDA; absence of protocol-defined relapses, 24-week confirmed disability progression, contrast-enhancing T1-weighted and new/enlarging T2-weighted lesions), with MRI rebaselining at CASTING Week 8. Safety outcomes included incidence/nature of adverse events (AEs). Results: As of October 12, 2020, 439/680 CASTING patients rolled over to LIBERTO. NEDA was observed in 82.6% of patients from baseline to Year 1 (n/N=549/665), 87.0% of patients from Year 1 to Year 2 (n/N=571/656) and 82.5% of patients from Year 2 to Year 3 (n/N=235/285). Over the 3-year period, 59.4% of patients had NEDA (n/N=190/320). Mean (SD) Expanded Disability Status Scale score was 2.09 (1.06) at CASTING baseline and 2.16 (1.48) at Year 3. Annualized relapse rate remained low (Year 1, 0.07; Year 2, 0.05; Year 3, 0.05). Overall, 92.3% of patients reported AEs (n/N=405/439) and 8.4% of patients reported serious AEs (n/N=37/439). Four patients from LIBERTO discontinued due to AEs (0.9%); one death occurred in CASTING. Conclusions: Patients with a suboptimal response to one or two prior DMTs who switched to ocrelizumab responded consistently well to ocrelizumab treatment over 3 years, based on clinical and MRI measures. No new safety signals were observed. Disclosure: Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for La revue des microbiotes. The institution of Patrick Vermersch has received research support from Roche. The institution of Patrick Vermersch has received research support from Sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for novartis. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for alexion. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene/Bristol Myers Group. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen Pharmaceutics. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. The institution of Prof. Van Wijmeersch has received research support from Merck. The institution of Prof. Van Wijmeersch has received research support from Roche. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristows. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi-Aventis. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Argenx. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for IGES. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Immunovant. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson&Johnson. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PSI CRO Deutschland GmbH. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Aventis. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Dr. Wiendl has received research support from Biogen. The institution of Dr. Wiendl has received research support from Merck. The institution of Dr. Wiendl has received research support from Novartis. The institution of Dr. Wiendl has received research support from Hoffmann LaRoche. The institution of Dr. Wiendl has received research support from Deutsche Forschungsgemeinschaft. The institution of Dr. Wiendl has received research support from Federal Government of Germany. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wuerfel has received personal compensation for serving as an employee of MIAC AG. The institution of Dr. Wuerfel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Actelion. The institution of Dr. Wuerfel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. The institution of Dr. Wuerfel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Buffels has nothing to disclose. Petra Dirks has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd . Thomas Kunzel has received personal compensation for serving as an employee of Roche. Karen Kadner has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Rewind.