New lupus drug

[Wendy39]

My friend just sent me this link.

It sounds great but how many are actually accessing these new “miracle” drugs??

dailymail.co.uk/health/arti...

[Kevin53]

Lupus UK and the Medical Research Foundation have been backing Dr Vital’s research team for several years. Fingers and everything crossed! Best wishes Kevin

[Wendy39 in reply to Kevin53]

That's great to hear! I know LUPUS UK play a large roll in research. Love his name too, very apt, Dr Vital!

These kind of newspaper articles also help raise awareness amongst the general public.

All positives.

Wendy

[Kevin53 in reply to Kevin53]

It’s interesting that the 15000 patients come from:

This is NICE: (the contradiction is in the first sentence)

”There are currently around 15,000 people in England and Wales with SLE and approximately 2000 people are diagnosed with SLE each year.

If 2000 new patients are diagnosed each year there must be 80,000 to 100,000 with SLE in the UK.

Best wishes Kevin

[Wendy39 in reply to Kevin53]

When I saw my AM (Angela Burns) in December, she told me that Health Boards must keep numbers of lupus patients on their lists and she would do a Freedom of Information Request for all Health Boards in Wales to get this information. But I don't think it will be that easy. From my experience they do not keep figures for us with lupus, sjogren's etc. They've never quoted figures at me in all of the time I have been corresponding with the health board. They keep RA stats though.

[misty14]

You beat me to it Wendy posting about this new drug!. Its the one I posted about a couple of months ago!. It's fantastic news and gives us heart that there's something else to try if we're struggling on the usual treatments!. There's been so little new drugs for lupus compared to RA. Last one was Benlysta after fifty years of no new new lupus drugs!.

At the moment it's still being trial led up north and won't be available for another 2-3 years and of course there's the cost implication !.

Hurrah for lupus uk funding some of this research!. Perfect name dr vital!. Hope your recovering ok. Xx

[fabwheelie]

I think we may be getting a lot of posts since this was in the news

Here's my reply to someone else's post about the same thing on this health unlocked

I'd be interested what others think. I'd seen a few posts in Lupus Facebook groups about this

Here's a useful link about it as reported at American College of Rheumatology meeting. The first phase trials didn't "meet endpoints" but subsequent trials look promising ( possibly different dosage in first trials). It appears from this good for overall disease activity and reducing steroid use as well as the effects on skin rashes ,( so possibly good for SLE as well as discoid lupus).

acrabstracts.org/abstract/e...

I've not personally had chance to fully read up about this or examine the scientific data, but hopefully it is as good news as the article suggests.

[Roarah]

It is a drug ending in " mab" ( a monoclonal antibody biologic) so it will likely be pricey which sadly will likely limit its availability.

[Jmiller623]

So I looked up the TULIP study for this drug anifrolumab in New England Journal of Medicine. Based on the statistics, I’d hardly call it a miracle drug. It inhibits the interferon system like many drugs used for crohns/ulcerative colitis. It looks like the drug improves outcomes a bit more than placebo - we’re talking 35% (placebo) vs 50% (drug) response rate. This is quite an astonishing placebo efficacy by the way. Maybe hydration via IV does a body good for us luppies. The drug also has the risk of infection mostly citing an increase in herpes virus and respiratory infections.

I don’t know.....seems like Benlysta Jr. As roarah lamented, AstraZeneca will be sure to rob us blind with this NEW drug. I don’t understand why we can’t use rituxan, remicade or humira in trials for lupus. Oh that’s right, pharmaceutical companies would lose money because these drugs are well established and have cheaper biological producers.

Not to be a Debbie downer but touting this as a miracle in the media is so misleading.

[Paul_Howard Partner LUPUS UK in reply to Jmiller623]

The article by the Daily Mail is very sensationalist. We've now published our own at lupusuk.org.uk/anifrolumab/

Regarding your point about the placebo response rate - this is a common stumbling block in trials for lupus medications. The reason for this is that it is unethical to give one group of patients a treatment and have the other group on no treatment at all. Therefore both groups will be receiving standard treatment and then one of the groups will receive the trial compound and the other will have placebo. As both groups are on standard therapy, we would expect patients from both groups to improve - the challenge is showing that the new compound is more effective than standard therapy on its own!

[Jumper99 in reply to Paul_Howard]

Hi Paul

Has any testing been done on patients with APS or APS and Lupus? What I’m try to ask is, if it’s safe for lupus patients to take will it also be safe for those who have APS as well? Or would that make those patients unsuitable for the drug?

[Paul_Howard Partner LUPUS UK in reply to Jumper99]

Hi Jumper99 ,

I'm not aware of this drug having any clinical trials to check safety and efficacy in APS at present. It is possible that if it is successful in obtaining licensing that researchers will trial it for other uses such as APS. Fingers crossed.

[Jumper99 in reply to Paul_Howard]

Thanks

[Jmiller623 in reply to Paul_Howard]

Hi Paul. In the protocol, it says most will be receiving antimalarials or slow acting immunosuppressants (whatever that means) as standard care. They are also allowed a steroid burst with taper in the first 12 weeks of either treatment. Interestingly, the inflection point for response is at 12 weeks. Like you said, it’s hard to tell what is what with regards to what is actually the most efficacious. You’d imagine that anifrolumab reduces need for steroid burst given that it purports reduced steroid need but reduction is minimal.

I am really hoping to make it to Lupus Summit in DC in March. As someone who has done research and well entrenched in the trial culture for about 15 years, it blows my mind that there aren’t more lupus trials with existing biologics. I know the population isn’t robust enough to test multiple treatments at once but I feel like trials move at a glacial pace having to go through phase 1 and 2 when there are drugs well established that work on the same pathways that could start at phase 3.

Is it just me or is the lupus drug market cornered? It’s sad and I have this gut feeling that patients are taken advantage of because they are in desperate need of anything that improves functionality.

Thanks for sharing a more realistic view of the recent study. Much appreciated!

[miccika1]

Not impressed with this drugs performance but it appears to be helping a subset of folks so that good. Hope it will help some people.

[Jmiller623]

Those are just a few examples. Honestly rituxan isn’t the best example I could’ve given. It’s an anti-CD20 antibody which targets B cells so they stop making antibodies. We hand it out like candy for lymphomas and chronic lymphocytic leukemia because it’s pretty well tolerated.

The average time it takes to develop a new drug from start to finish/lab to bedside is 10+ years and even longer in diseases like lupus because there isn’t a huge patient population to study so it takes forever to get enough people enrolled before it can move to the next phase. We have so many monoclonals that target the interferon pathway that have already passed phase 1 and 2. That cuts off 5-8 years in time for getting it approved for other uses like lupus.

I wish they’d find another more specific target further down the inflammation pathway/antibody making process that would result in less side effects. I feel like they just made another drug just like the others but will be used specifically for lupus. Researchers need to go outside the box with targets.

[Jmiller623]

No problem. Happy to help in even the smallest of ways. Sometimes I get a little too technical but I know a lot of the people on here are more informed than doctors in most cases.

[KayHimm in reply to Jmiller623]

I am curious if the problem with drug effectiveness and lupus is the disease’s complexity. Do you think the fact that RA is more of a single auto-antibody disease as opposed to lupus which tends to have multiple antibodies makes RA easier to treat? I am probably being too simplistic, but I am trying to understand why they have made more progress in RA treatment than lupus, if, in fact, that is the case.

Xk

[Jmiller623 in reply to KayHimm]

Most certainly. RA is also limited to mostly arthritis as the most disabling symptom whereas lupus is a disease that can and does seem to effect everything. However, it does all come down to antibodies and autoantigens in the end.

I wondered if the opposite of new immunotherapies used in cancer which upregulates CTLA-4 and blocks PDL-1 activity would be of use. Down regulating/enhancing these factors in autoimmune diseases might be of use but would increase the risk of cancer. Maybe a good option with close cancer screening.

Just some thoughts I have in the outside of the box spectrum. Lupus is definitely one of if not the most complex and puzzling disease I’ve come across. So many flavors with no one cause.

[KayHimm in reply to Jmiller623]

Thinking outside of the box is important!