Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study.

INTRODUCTION: Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing-remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. METHODS: This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. RESULTS: A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14-0.21) from the baseline of 0.42 (95% CI 0.38-0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12-24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. CONCLUSION: Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression.

Síndrome de Foix-Chavany-Marie como forma de presentación de esclerosis múltiple / Foix-Chavany-Marie syndrome presenting as multiple sclerosis

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Síndrome meníngeo y síndrome de Guillain-Barrè en un paciente con artritis reumatoide tratado con adalimumab / Meningeal and Guillain-Barrè syndrome in a patient with rheumatoid arthritis receiving adalimumab therapy

Adalimumab es un anticuerpo monoclonal recombinante humano que bloquea el efecto del factor de necrosis tumoral alfa. Actualmente se emplea como tratamiento para la artritis reumatoide, siendo la desmielinización un potencial efecto adverso. Nuestro caso trata de un varón de 31 años con artritis reumatoide seropositiva que presentó un cuadro diarreico después de la segunda dosis de adalimumab. Tras tratamiento con ciprofloxacino el paciente desarrolló un síndrome de Guillain-Barrè confirmado por electromiografía. El estudio del líquido cefalorraquídeo sugirió un síndrome meníngeo o una posible meningitis bacteriana decapitada. El tratamiento con adalimumab puede asociarse con el desarrollo de enfermedades desmielinizantes e infecciosas y afectar simultáneamente al sistema nervioso central y al periférico (AU)

Adalimumab is a recombinant human monoclonal antibody that blocks the effects of tumor necrosis factor-alpha, and is presently used for treatment of rheumatoid arthritis, with demyelination being a potential adverse effect. A 31 year-old male with seropositive rheumatoid arthritis presented with diarrhea after the second injection of adalimumab. He was treated with ciprofloxacin. In a few days he developed a Guillain-Barrè syndrome confirmed by electromyography, and his cerebrospinal fluid was compatible with meningeal syndrome or partially treated bacterial meningitis. Adalimumab may be associated with the development of demyelination and infectious diseases. Moreover, both the central nervous system and the peripheral nervous system can be affected (AU)

[Meningeal and Guillain-Barrè syndrome in a patient with rheumatoid arthritis receiving adalimumab therapy]. / Síndrome meníngeo y síndrome de Guillain-Barrè en un paciente con artritis reumatoide tratado con adalimumab.

Adalimumab is a recombinant human monoclonal antibody that blocks the effects of tumor necrosis factor-alpha, and is presently used for treatment of rheumatoid arthritis, with demyelination being a potential adverse effect. A 31 year-old male with seropositive rheumatoid arthritis presented with diarrhea after the second injection of adalimumab. He was treated with ciprofloxacin. In a few days he developed a Guillain-Barrè syndrome confirmed by electromyography, and his cerebrospinal fluid was compatible with meningeal syndrome or partially treated bacterial meningitis. Adalimumab may be associated with the development of demyelination and infectious diseases. Moreover, both the central nervous system and the peripheral nervous system can be affected.