Golimumab

[ouchyk]

J&J, Schering-Plough arthritis drug meets goals
Wed Nov 7, 2007 5:50pm EST
By Toni Clarke

BOSTON, Nov. 7 (Reuters) - Johnson & Johnson (JNJ.N: Quote, Profile, Research) and Schering-Plough Corp (SGP.N: Quote, Profile, Research) said on Wednesday that their experimental drug golimumab was effective in clinical trials in reducing symptoms of psoriatic arthritis and ankylosing spondylitis -- conditions related to rheumatoid arthritis.

In two late-stage studies, golimumab met the main goals and significantly improved symptoms of both disorders compared to patients taking a placebo, according to data presented at the annual scientific meeting of the American College of Rheumatology in Boston.

Psoriatic arthritis combines the characteristics of arthritis and the skin disorder psoriasis, while ankylosing spondylitis is a progressive form of spinal arthritis that can cause fusing of the vertebrae.

Golimumab works by blocking an inflammatory protein known as tumor necrosis factor, or TNF.

In a 405-person trial of patients with psoriatic arthritis, 51 percent of patients receiving 50 milligrams of the drug and 45 percent of patients taking 100 mg saw their arthritis symptoms improve by at least 20 percent, compared with 9 percent of patients taking a placebo after 14 weeks.

At 24 weeks, 61 percent of patients who took the higher dose of golimumab achieved a 20 percent reduction in their symptoms, compared to 12 percent of patients who took a placebo. Of patients who took the lower dose, 52 percent achieved a 20 percent improvement, researchers said.

In a trial of 356 patients with active ankylosing spondylitis, 59 percent of patients receiving 50 mg of the drug and 60 percent of patients receiving 100 mg achieved at least a 20 percent improvement in their symptoms, At 24 weeks, 66 percent of patients receiving the higher dose of golimumab and 56 percent who took the lower dose achieved a 20 percent improvement in symptoms compared with 23 percent of patients receiving a placebo. The drug is also in late stage trials as a treatment for rheumatoid arthritis with results expected next year.

J&J said it expects to file for marketing approval for all three indications in 2008.

Anti-TNF drugs are one of the most successful groups of all biologic medicines. They include Abbott Laboratories' (ABT.N: Quote, Profile, Research) Humira, Amgen Inc's (AMGN.O: Quote, Profile, Research) Enbrel and J&J's (JNJ.N: Quote, Profile, Research) Remicade, which together generated sales of nearly $10 billion in 2006.

Side effects of golimumab were similar to those seen with other TNF-inhibitors, said Dr. Arthur Kavanaugh, professor of medicine at the University of California, San Diego, and lead investigator of the psoriatic arthritis trial.

Golimumab's makers believe it will have a competitive edge over other drugs in the class as it is injected by the patient once a month. Rival Humira must be injected once every two weeks and Enbrel is injected once a week. Remicade is given once every two weeks intravenously at the hospital.

The companies hope golimumab will also win approval to be given as an intravenous treatment once every three months.

I'm not sure they got the remicade dosage correct unless they are talking about loading dose...and I do humira weekly .... :confused:

ah well.

[jason_winnipeg]

Yes, I can attest that Golimumab is the most magical drug ever created by man! I am in the trial for the last yr and it has been beyond belief for fixing everything.

I have virtually no P, but many joints of PA. This drug pretty much cleared up everything one day after the first injection. It was miraculous. After metho, plaquenil, and others did nothing, this drug was it after 4 yrs. And it works after only monthly injections, which is another miracle. And I have seen no tailoff whatsoever. I could not tell you whether I just injected, or it is day 29. That to me is quite amazing as well.

I have just passed year 1 of 5 scheduled. I have been told this drug will have FDA approval most likely 1st or 2nd qtr in the US. It does give hope that if this drug works this well, just think of what comes next...and next..and next...

[nyoki]

Excellent news. I've been through Enbrel (2x weekly 50mg), Humira (1x weekly) and Remicade (IV every 6weeks) and I was terrified that remicade would stop working so well for me. Now, it appears, there will be Golimumab and Orencia added to options.

Loup Méchant

[ouchyk]

Jason,

Good to " hear " from you again! Wonderful to hear that the medication is working out so well for you, I look forward to the newest meds coming down the pike at us. 5 year trial...awesome!

Karen

[petey]

Good news jason from winnipeg! Just a bit more information though on how well it works for psoriatic arthritis.And also for nail psoriasis.I'm in the cnto-1275 trial so when I hear your praises for this new treatment,I know just what you mean!

[MikeK]

Hi Jason,

Welcome back! I'm thrilled to hear that you're doing so well Golimumab. I know how much you were suffering. I also want to thank you for taking part in the trial. It's brave people like you and Petey that are going to pave the way for the rest of us.

Thanks again,

Mike

[aaabooks]

I'm currently on methaltrexate (which has helped immensely). Are those of you in the clinical trials of golimumab taking methaltrexate in addition to the golimumab?

[RichJ]

hi aaabooks,
welcome to the p family. you have met some of the wonderful people on here and will find alot of great info. welcome and nice to meet you.

have a good weekend all

richard

[Re]

aaabrooks, so glad that you have joined the family. you will see different threads that will be helpful, some might be sad, some might be quirky thoughts. There are even some where we disaggree with each other but the one thing is that we are all different but brought together because we have the disease. That makes us family. Just like with family we might have a bit of a squable but we are still there for each other. No matter what we will be there for you too.. I love my p and pa family even if we don't always agree. So glad you have become another family member but really sorry you had to. When I first joined I was so happy that all of this was not in my head and then I cried to know that everyone was in the same shape that I am in. Misery loves company? Na, we just love each other and share the good, the bad, and the ugly. (wha, wha, wha....music)
Welcome to this family of love that is a mixed bag of nutz

Re

[jason_winnipeg]

Hi Everyone,
Hey, thanks for all the nice hellos. Yes, I have been away for what seems like..hmm..forever! Its been a bad year...but not on the arthritis front.

Its funny how life works. Just over a yr ago I was losing faith in my rheumy. I have coverage for everything under the sun drug wise. So when metho was doing nothing for me, and I couldnt drink my wine!, I asked to be put on one of the biologics.

He was very unhelpful. I know the insurance companies usually want you to fail on all the cheap drugs first (ie. metho, plaquenil, sulfa), and I had done that already. Plus, my ins company is very lenient and after speaking with them, they only needed a letter from my rheumy. So I thought, cool, this is going to be easy. Except I didnt realize my rheumy wouldnt be on myside 100%.

So I went looking for another rheumy, which is a lot harder than I realized. Its not easy to change I quickly found out. And then low and behold I found my current rheumy, who is fabulous, and who just happened to be filling patients for the golimumab study that closed a week later. So my file came across his desk, he quickly took me as a patient based on my PA and drugs I already have tried, and got me on the study on the last day before cutoff. I am not sure what the exact definition of fate is, but this story has got to be damn close.

So now, to answer aaa's query, I am on goli one a month injected, and WAS still on my one day 200mg celebrex pill. Nothing else. But I recently have even been able to drop my Celebrex to every other day, and now have even moved to Tylenol Arthritis every other day, instead of Celebrex as per my rheumy's direction. Very promising. And yes it is a 5 yr study..they told me if you can get 3 yrs or so from one of these drugs before it stops working for you, that is really good. So interested to see how things go..but so far after 1 yr it has been magical...I can run up and down stairs!! I play racquetball again! I walked like an old man one year ago. I had much difficulty going up and down stairs. I could not run really at all, it was a slow jog at best. Makes me think I shoudl have sent a Xmas card to the good people at Centocor...its the least I could have done...:)

[petey]

Ah...this was the reply I was waiting for! Just an explanation of what you said..

"they told me if you can get 3 yrs or so from one of these drugs before it stops working for you, that is really good."

I know this is a problem with the biologics to date but do you know specifically that this will be the same with golimumab? I suppose the future remains to be seen unless you were told this by Centocor which I think would be a hot piece of information-You are the only golimumab patient that I know of here so forgive me if I'm asking some tough questions.I have 1 month to go before I get the next cnto-1275 shot-on a 12 week schedule and psoriasis is maybe 1 or 2 % and the psoriatic is probably the same as you-I can run up and downstairs with ease.What a great thing! pete

[jason_winnipeg]

Hi Pete,
LOL! No, if Centocor had said that..well, whomever from their company I am sure would have been hung out in the woods..

Those comments were from my rheumy when I started the trial. He said on any of the biologics, there can come a time where the body starts in essence rejecting them, and there potency starts to diminish. So my rheumy told me that if I was to get 2-3 yrs on goli, that would be a good thing. And semi normal under all circumstances. You would then look at moving to whatever else has come out, or is alreayd on the market, and so on. But keep in mind there is nothing to say that your body might not reject it ever. He just stated that in some cases, getting upwards of 3yrs from a biologic was a good thing and not to look at that as a negative should it happen with goli.

He also mentioned last month that there is some data of people actually coming off this drug, as with any biologic, and not needing any drugs. I guess its the case of the biologics actually having the CHANCE to correct the illness for good. Albeit it is too early to tell just what those chances are, and I am sure they are slim as heck, but just that thought alone is kind of uplifting, that these drugs HAVE actually allowed people to get better and then at some point come off of them to no pain...

From what he has stated so far, the data on goli to date is very positive, so I am not surprised it has worked so well. And I am sure there will even better ones to come. The nice thing for me is obviously how well it has worked, but also the fact the injection is only once a month.

J

[petey]

good to hear...loooking forward to hearing more posts of the same positive results-relief from such a crappy disease!