Friday, 7 July 2017

Natalizumab helps maintain quality of life

Foley JF, Nair KV, Vollmer T, Stephenson JJ, Niecko T, Agarwal SS, Watson C. Long-term natalizumab treatment is associated with sustained improvements in quality of life in patients with multiple sclerosis. Patient Prefer Adherence. 2017;11:1035-1048.

BACKGROUND:Multiple sclerosis (MS) patients experience lower health-related quality of life (HRQoL) than the general population. In clinical trials, natalizumab significantly improved HRQoL and reduced relapse rates and disability progression in patients with relapsing MS. In a 1-year analysis of patients included in the current study, HRQoL improvement occurred within 3 months of natalizumab initiation and continued for 1 year thereafter. However, natalizumab's long-term efficacy in improving HRQoL has not been studied.
METHODS:In this longitudinal, observational, single-arm US study, HRQoL and treatment satisfaction were evaluated in MS patients receiving intravenous natalizumab 300 mg every 4 weeks in clinical settings. Patients completed surveys at baseline and every 6 months for 3 years and reported the following measures: Short Form-12 Version 2 (SF-12v2), Multiple Sclerosis Impact Scale (MSIS-29), and Treatment Satisfaction Questionnaire for Medication.
RESULTS:In this study, 120 patients completed ≥3 years of natalizumab treatment. Significant HRQoL improvements were evident from baseline to year 3 by increases in SF-12v2 Physical Component Summary (PCS) and Mental Component Summary scores (P<0.01) and decreases in MSIS-29 physical and psychological scores (P<0.0001). Patients with less physical disability (baseline Disease Steps [DS] 0-2) had significant improvement from baseline to year 3 in SF-12v2 PCS (P<0.05) and MSIS-29 physical scores (P<0.05). Physical HRQoL outcomes in patients with baseline DS 3-6 remained stable over 3 years. Treatment satisfaction increased significantly from baseline to year 1 (P<0.0001) and was maintained in the following 2 years.
CONCLUSION: Patients reported physical and psychological HRQoL improvements over 3 years of natalizumab treatment, supporting the long-term efficacy of natalizumab in real-world settings. Lower baseline disease activity and earlier treatment were related to better outcomes, indicating the importance of starting natalizumab early in the disease course. Treatment satisfaction increased after natalizumab initiation and remained high over 3 years of treatment.

We all know that natalizumab can be a very good drug and this paper says if your disease is kept in check you feel that life is better, so this study says that natiluzumab is a useful therapy over a 3 year period.

CoI: None

16 comments:

  1. Nice picture.

    731 with PML up to now (June 6). Death rate increased to 24% for a first time. Total count: 731*24%= 175 people dead.

    556 survivors struggle with new disabilities.

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  2. In the beginning, there were 333 patients who remained on natalizumab for a year at least, but ...

    "...at 3 years, 155 patients had completed the survey, 120 of whom were still on natalizumab. Reasons for discontinuation of natalizumab were not collected in this study."

    This survey has selection bias written all over it.

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    Replies
    1. You can only use the data you're able to collect at 3 years. Hardly selection bias is it?

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    2. Whether intentional or not, it still is huge bias. Call it whatever you like.

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    3. I'd call it analysis of the available data but of course in your world that equates to "huge bias".
      Hey ho, whatever.

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    4. https://en.wikipedia.org/wiki/Selection_bias

      "Selection bias is the bias introduced by the selection of individuals, groups or data for analysis in such a way that proper randomization is not achieved, thereby ensuring that the sample obtained is not representative of the population intended to be analyzed."

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    5. Not applicable here. The point is they are analysing data from pwMS who have been on natilizumab for 3 years. You can't do that for those who were no longer taking it at 3 years. Therfore the sample analysed is representative of those who had taken natilizumab for 3 years. Clearly stated in the paper by the authors so they're not hiding anything.
      You have a case of chronic whataboutery.

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    6. The authors had available data from 155 patients. but only used 120 because only 120 had taken nataliz for 3 years.

      Available data from 35 patients were not analyzed, therefore the authors analyzed all available data. Skol!

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    7. But those 35 pwMS of 155 who had filled in a questionnaire were no longer taking natilizumab at 3 years so not included for obvious reasons.
      Are you being deliberately obtuse?
      Iechyd da!

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  3. ...Tysabri s a possible cause of melanoma thereby complicating Tysabri's treatment of MS.

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    1. "The multiple sclerosis therapy Tysabri (natalizumab) could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned.
      Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said."
      https://multiplesclerosisnewstoday.com/2017/06/30/report-says-ms-therapy-tysabri-could-be-linked-to-development-of-melanoma/

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    2. Good one MD2. I suppose any drug that blocks the immune system surveillance, specifically T-cells, would lead to an increase in skin cancer.

      I believe that the basis for the new immunotherapy anti-cancer agents (anti-pd1 therapies) is that it opens up tumours to your own immune system to then attack the tumour. I suppose anything that dampens this immune system would increase a patient's risk of many types of cancer, including skin.

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  4. Replies
    1. Death rate of people getting PML This is not the death rate of people taking natalizumab.

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  5. Shocking conclusion! What about reversing established disability? Don't we have enough DMDs? Improve function and watch QoL measures skyrocket. Push some research dollars into neurogenesis . It's chronic disability that destroys hope.

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