Methotrexate injection for psoriasis 52 week study

[Fred]

This study may interest those of you using methotrexate for psoriasis.

Quote:

---

Background:
Methotrexate is one of the most commonly used systemic drugs for the treatment of moderate to severe psoriasis; however, high-quality evidence for its use is sparse and limited to use of oral dosing. We aimed to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis.

Methods:
We did this prospective, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (METOP) at 16 sites in Germany, France, the Netherlands, and the UK. Eligible patients were aged 18 years or older, had a diagnosis of chronic plaque psoriasis for at least 6 months before baseline, had currently moderate to severe disease, and were methotrexate treatment-naive. Participants were randomly assigned (3:1), via a computer-generated random number sequence integrated into an electronic data capture system, to receive either methotrexate at a starting dose of 17·5 mg/week or placebo for the first 16 weeks, followed by methotrexate treatment of all patients up to 52 weeks (methotrexate–methotrexate vs placebo–methotrexate groups). Dose escalation to 22·5 mg/week was allowed after 8 weeks of methotrexate treatment if patients had not achieved at least a 50% reduction in baseline Psoriasis Area and Severity Index score (PASI), with corresponding volume increases in placebo injections. Treatment was combined with folic acid 5 mg/week. Group allocation was concealed from participants and investigators from the time of randomisation until an interim database lock at week 16, and was open label from week 16 onwards, with no masking of participants or investigators. The primary efficacy endpoint was a 75% reduction in PASI score (PASI 75) from baseline to week 16. We did analysis by modified intention to treat, with non-responder imputation. This study is registered with EudraCT, number 2012-002716-10.

Findings:
Between Feb 22, 2013, and May 13, 2015, we randomly assigned 120 patients to receive methotrexate (n=91) or placebo (n=29). At week 16, a PASI 75 response was achieved in 37 (41%) patients in the methotrexate group compared with three (10%) patients in the placebo group (relative risk 3·93, 95% CI 1·31–11·81; p=0·0026). Subcutaneous methotrexate was generally well tolerated; no patients died or had serious infections, malignancies, or major adverse cardiovascular events. Serious adverse events were recorded in three (3%) patients who received methotrexate for the full 52 week treatment period.

Interpretation:
Our findings show a favourable 52 week risk–benefit profile of subcutaneous methotrexate in patients with psoriasis. The route of administration and the intensified dosing schedule should be considered when methotrexate is used in this patient group.

Source: thelancet.com

*Funding: Medac.

[jiml]

An interesting study which shows the effectiveness of methotrexate as a treatment ...but it was a small study of 120 people.. and it would be interesting to see if there was any drop out and the reasons to drop out after the 52week trial..It would be interesting to know what the adverse effects were on the 3% were and were there any other common side effects

I have no doubt methotrexate works well, but my experience on it would not allow me to try it again even by injection

[Fred]

An interesting study which shows the effectiveness of methotrexate as a treatment ...but it was a small study of 120 people.. and it would be interesting to see if there was any drop out and the reasons to drop out after the 52week trial..It would be interesting to know what the adverse effects were on the 3% were and were there any other common side effects

I have no doubt methotrexate works well, but my experience on it would not allow me to try it again even by injection

No I would never use it again, and to be honest I think it was time it was dropped from the list for psoriasis.

But that's just my personal opinion.

[pingu]

This is the first study report I have read and although I do not understand much of it I am astonished by the comment.

Subcutaneous methotrexate was generally well tolerated; no patients died or had serious infections, malignancies, or major adverse cardiovascular events. Serious adverse events were recorded in three (3%) patients who received methotrexate for the full 52 week treatment period.

OK nobody died! Was that a potential outcome!

I have just started on subcut MTX and will give it a few months to see how it improves things.

My consultant suggests the same dosage using subcut MTX has an absorption of about 90% against 60% for oral so should be more effective. I only have a few small patches that have crept back but knowing there is an opportunity to clear my psoriasis I will take it. As with any medication I accept there are risks. Fortunately I have had zero side effects but if it continues to return will need another alternative.

[D Foster]

Well how interesting MTX works who would have suspected that and no adverse effects apart from 3% who I would suspect had difficulty tolerating with gut problems being the main trouble.
I would like to see it compared with other treatment because I think that some of the others will be far worse and I can think of a couple like cyclosporine .

[Fred]

All treatments have risks or problems. But we have to go by what we think is best for us as individuals.

Personally Methotrexate  gave me huge problems in pill or injection, but we are not all the same. I can understand your astonishment that they had to mention "no patients died or had serious infections, malignancies, or major adverse cardiovascular events" But today they have to tell us if 1 person may sneeze after opening a bottle of wine. It doesn't mean we will all sneeze and it doesn't mean that methotrexate will work for you or you may die. It is a study and a study based on what they wanted to study, and could even be based on the way they want the result to be.

I'm not saying the study is wrong or that my opinion of methotrexate is wrong. What you have to do as the person using it is to weigh up what you think and report back to help others.

I give the information published on the most reliable sources and post it here, but it's our members that give the best conclusions in my opinion.  

I don't know the difference between oral and injection, all I can do is say that for me they were both something I would never take again. I too would also like to see a comparison between methothrexate and other treatments, but to be fair a study has to draw a line somewhere.

At the end of the day we all have to decide for ourselves the treatment that we think is best for us.

[D Foster]

I agree Fred we are all different and tolerate each treatment the same way , I was on MTX for 9 years but it beat me in the end whereas 6 weeks on Cyclosporine and 4 months on Acetrerin was more than enough and I had had enough in fact before that after UV treatment I had to have growth removed off my back so as you said risk is in all treatment.
Even the most common drugs like paracetamol can be a problem to some .

[mataribot]

Most people get 2 - 4 years from MTX before anything bad happens. This study is to short to make conclusions on the harm this drug can cause.

[D Foster]

Well MTX has been used for many years for arthritis in usually slightly higher doses and even higher doses for several types of cancer so as regarding the safety of using it and side effects that is fairly well documented , what the study was trying to do is access the drug as a useful one for psoriasis and not really the safety side though obviously it would come into the conclusions as it will be a big factor that determines the usefulness of a drug to be used .
The main problem with MTX is that it is the old saying "give a dog a bad name" and that name is CANCER which is the reason that it was used in the first place so now it has this spectre in the back of peoples mind which they probably don't even acknowledge or realise but it is there and it now suffers from this and carries the prejudice with it and I suppose fear as well.

[Fred]

The main problem with MTX is that it is the old saying "give a dog a bad name" and that name is CANCER which is the reason that it was used in the first place so now it has this spectre in the back of peoples mind which they probably don't even acknowledge or realise but it is there and it now suffers from this and carries the prejudice with it and I suppose fear as well.

And it's also used for ectopic pregnancy. A drug used for that and cancer is not suitable for people with psoriasis.

It's a poison and should be banned for use with psoriasis patients. When you read most of the comments on Psoriasis Club about methotrexate from our members most have a negative opinions about it. Yes it works and some can handle it, but things have changed and there are better treatments out there than poison.