1 Year risk-benefit of subcutaneous methotrexate for psoriasis

[Fred]

This study set out to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe chronic plaque psoriasis.

Quote:

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Aim:
Warren et al set out to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe chronic plaque psoriasis.

Setting and design:
This is a prospective, double-blind, randomised (3:1), placebo-controlled study, conducted across 16 centres in Germany, France, the Netherlands, and the UK.

Study exposure:
Methotrexate-naïve adults with a diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months before baseline were randomly assigned to receive weekly subcutaneous injections of either methotrexate at a starting dose of 17.5 mg, or placebo for 16 weeks (first phase).Dose escalation to 22.5 mg/week was implemented after 8 weeks if patients did not achieve PASI 50. Treatment was combined with folic acid 5 mg/week. The first phase of the study was followed by an open-label period from 16-52 weeks (second phase), in which both groups received weekly methotrexate injections. At week 24, dose escalation to 22.5 mg/week was possible in patients not achieving PASI 50.

Outcomes:
Psoriasis severity was measured using the PASI (Psoriasis Area and Severity Index). The authors also used two other psoriasis severity measures and two quality of life measures, looked at safety indices and performed a sub-study analysing paired skin biopsies at baseline and week 16 (histopathology, immunohistochemistry and expression of interleukin (IL)17A, interferon-γ and tumour necrosis factor-α).

Primary outcome measures:
The primary outcome was the proportion of patients reaching PASI 75 at week 16.

Results:
120 patients were included in this trial, most of whom were middle-aged white men with longstanding psoriasis and a mean BMI of 30.1 kg/m2. PASI 75 was achieved in 41% of patients receiving methotrexate vs. 10% of patients receiving placebo (RR 3.93, 95% CI 1.31–11.81; p=0.0026) at week 16. Subcutaneous methotrexate was generally well tolerated, with no serious adverse events related to this treatment over the 52-week study.

Conclusions:
Warren et al conclude that the 52-week risk-benefit profile of subcutaneous methotrexate is favourable in patients with psoriasis.

Source: onlinelibrary.wiley.com

*Early view funding unknown.

[Bill]

You know, Fred, the thing that utterly amazes me in studies like this is how 10% of people with moderate to severe disease achieve pasi 75 with a placebo. I would like to see an experiment where patients are given the same treatment but are divided into groups and given different pricing information. My guess is that the more expensive treatment would have better results.

Cheers

[Fred]

You know, Fred, the thing that utterly amazes me in studies like this is how 10% of people with moderate to severe disease achieve pasi 75 with a placebo. I would like to see an experiment where patients are given the same treatment but are divided into groups and given different pricing information. My guess is that the more expensive treatment would have better results.

Cheers

My thinking Bill is placebo will always work for some people and they have to judge a treatment against a placebo to see the benefits. Some studies do look at biosimilars which are lower in cost , but my guess is you would like to see a study comparing your treatment against something like Tecfidera.

I doubt that will ever happen for two reasons.

#1 Biogen wouldn't like to see it happening.

#2 I doubt you would find enough people using or willing to use your treatment to do a fair trial.

By the way well done on reaching 1000 post. [thread=5526]  

[Bill]

Thank you, Fred. There has been a study that found expensive placebos to be 10% more effective than cheap placebos, so I don't think it unreasonable that an expensive secukinumab would work better than a cheap secukinumab.

Cheers