Is my doc recommending Humira too soon?

I work in the medical field and work very closely with my docs (been there for 10 years and so, I know all and see all). Sometimes this makes me a terrible patient because I have seen the behind the scenes of the medical industry and although its mostly good, some docs worry me with how aggressive or frivolous they are. So, my question....

I was diagnosed in May 2011. Pretty mild case of Crohns doc says (ileum & right colon). Asacol HD has worked pretty well for me so far and has really been my only drug used to keep me under control.

Recently, while I thought I was in remission (good stools & no cramping) a freaking ano-rectal fistula crops up out of no where (is that a common thing when all seems well?)!!! I have a seton in place and had to have it replaced once already due to infection not clearing fast enough. Things seem to be healing well now, but its really only been a week since last drain. I saw my GI and he wants me to consider Humira...

Is it too soon for that? I thought Humira was a once you've tried all other drugs kinda thing. I think he just wants to treat the fistula aggressively, but when I have no other symptoms is that wise? Can I use Humira until fistula heals and go back to just Asacol?

Side note: doc says he doesn't think steroids will help me. And, I do have a fear of this fistula getting infected again since the antbx (Levaquin & Flagyl) almost did me in. Lost 10 pounds due to no appetite and naseua.

Sorry so lengthy, any advice is appreciated!

It's very likely that he feels even without symptoms your disease is out of remission.

I hope you feel better soon.

Lauren

I think use of biologics are pretty common with fistulas. Steroids do nothing for fistulas. They are also very stubborn to heal. I have had one for almost seven years and another for five. flagyl is no longer effective, nor do I care to take it anymore and surgery was unsuccessful x 2. I just started remicade, I am hopeful that it works.

Some of the newer literature that I have found suggests biologics as a first course of action vice treatment with flagyl and surgery.

Alliruns - my doc did mention that they are more comfortable with biologics now and so maybe that's also why it seems more aggressive than lots of stuff I've read. Just not reading current enough stuff I guess. Thanks, still nervous but I don't know if I can take much more antbx/flagyl, so it may be my best option then.

PS - you ride a bike with fistulas (your avatar pic)? I haven't ridden my bike in a while and I can't even imagine trying. If you are then high fives!!!!

I have never had the joy of an anal fistula, but I would think that if that is starting up you are no longer in remission. I would make a move to a more aggressive drug.

myriahdawn said:

Alliruns - my doc did mention that they are more comfortable with biologics now and so maybe that's also why it seems more aggressive than lots of stuff I've read. Just not reading current enough stuff I guess. Thanks, still nervous but I don't know if I can take much more antbx/flagyl, so it may be my best option then.

PS - you ride a bike with fistulas (your avatar pic)? I haven't ridden my bike in a while and I can't even imagine trying. If you are then high fives!!!!

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Yes, I have been riding my whole life and refuse to give it up. It's all about the right shorts. The only time I didn't ride was with setons.

I'm sorry to hear about the fistula

I personally don't think he went to Humira soon enough. One, the active ingredient in Asacol (Mesalamine) has been shown to be no better than placebo in Crohn's disease and two, Asacol is formulated to treat disease of the colon so it was likely just waving to the disease in your ileum as it went by.

Now that you've moved into fistulizing disease, I'm afraid that it's heavier hitters for you from here on out. If you hate the idea of that, I'd suggest looking into Low Dose Naltrexone once the fistula has closed but your GI likely won't like the idea of that.

I only have my own experience to pipe up with, but it's 3 decades' experience, and while I understand and admit that some study (or studies?) have shown that mesalamine is not effective for Crohn's, Lialda CERTAINLY and without a doubt works for my Crohn's (which is confined to my large bowel) and it's not placebo action.

Now, that said, it may not work for you, but I have a big problem with implying that any Crohn's patient getting results from 5-ASA is willing the results into being. "Similar study results to placebo" is not the same as "it may as well be a placebo."

But I do agree with David that if you're fistulizing, you need something more.

I've also been told by two very smart doctors that I trust (and I trust very few), that the data just doesn't support LDN and the few existing studies are flawed, but it's worth doing your own research and homework on any and all available avenues, particularly if/when you are uncomfortable with your current treatment/results.

Studies including a Cochrane review of a bunch of studies.

I'm sure mesalamine does help a subset of people, especially with Crohn's Colitis. But there's a reason medications have to go through rigorous study processes to get approved and why no form of mesalamine has been approved in the treatment of Crohn's disease. When doctors prescribe it off-label by itself, I cringe. When they prescribe the incorrect formulation based upon disease location, well... yeah. Some people such as yourself get lucky muppet. This forum is packed full of people who were once on mesalamine who are not so lucky and have had a whole host of complications as a result. This thread adds one to that total.

The three studies for LDN have been small but had excellent results, including showing mucosal healing. I'm still waiting to see what this, "flaw" is that some people speak of, especially since the researcher who conducted these, "flawed" studies was just given a very prestigious position at the NIH. Someone better contact the NIH! Are these very smart doctors you speak of the ones who are treating Crohn's patients off label with mesalamine despite a whole host of big studies including a Cochrane review saying not to? Don't you think that is strange?

Since off label ASA keeps me out of the hospital and off steroids, I haven't written them off as crazies yet.

I'm not a big fan of appeal to authority, but Dr B explained his conversation with one of the prominent (lead) study doctors and I understood his concerns. I wish I could remember the conversation well enough to relate it properly. You know I'm big on data but I can't ignore that ASA has worked for me for 30 years.

Data can be weird, and is highly dependent on the collection methodology. Why would removing sulpha make it LESS effective, for example? The data shows that it is. I'd love to hear an explanation of that mechanism.

Anyway, not trying to threadjack, but I do think there's a distinction between "similar study results to placebo" and "you may as well take a sugar pill".

I certainly agree that doctors often prescribe forms of ASA that are targeted to the wrong area, or are targeted to only a subset of the area that the patient needs treatment for, and those cases ARE cringe-worthy. Doctors should know better. I also agree that it flat out doesn't work for some patients. It makes my daughter sicker, immediately.

But slavish adherence to prescribing guidelines seems out of character for you, it's odd to see you argue it.

Gah, I really didn't mean to threadjack this afternoon. I think the important bottom line here is that:

* 5-ASA is only effective for a minority of patients
* Yes, you can have asymptomatic inflammation that causes damage, even fistulae (I had this happen)
* If you are getting fistulas, it's a very strong indication that a change in your treatment, most probably to a stronger maintenance medication, is indicated. I don't know about Humira's record with fistulae but I do know that Remicade sometimes causes fistulae to heal for some patients.

muppet said:

But slavish adherence to prescribing guidelines seems out of character for you, it's odd to see you argue it.

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I'm a big fan of the top down approach. Taking it a step further, I am a bigger fan of the, "Shotgun approach" with stronger medications, lifestyle changes, diet, supplementation, etc etc. In my opinion, there is no such thing as mild Crohn's disease, just its present status. Inflammation needs to be brought under full control and mucosal healing induced as soon as possible so the status does not worsen. The data for mesalamine does not support that happening. If the data and experiences reported on this forum supported its use, I'd get my pom poms out.

With that said, I'd sooner go to a doctor who monitored me very closely but insisted on mesalamine versus a doctor who put me on Humira and sent me on my way with a, "Call if you get worse" type of approach to management of the disease.

I don't feel we're hijacking the thread (correct me if you feel otherwise myriahdawn!) We're providing differing opinions based upon exactly what myriahdawn asked.

Oh I know you're research driven, I just thought it was a little funny you used the "off label" argument, like it was aimed square at me.

Ah, I see. I could care less if doctors use medications off-label. But if the data doesn't back that up at all and that's all they use, then it concerns me a great deal. LDN is off label because it hasn't gone through phase III trials but preliminary studies have been very positive and members here have had great success with it. Mesalamine is off label because studies show it doesn't work and many here have had catastrophic failures with it. When I hear of GIs prescribing mesalamine for Crohn's but refusing LDN because it isn't proven, I just shake my head (and sometimes get angry). If they want to go strictly by data and not prescribe LDN, I understand and respect that. But don't turn around and prescribe just mesalamine two minutes later.

To be fair, the doc who prescribed me ASA might entertain LDN if I asked. The doc who refused LDN for Sarah did not prescribe her ASA. He's very data driven, and that's why he's pushing back on EEN for us (because Sarah's diagnosis is UC).

Maybe my Crohn's dx is bogus. It's recent (last 10 years) as compared to my UC diagnosis (from 1983), and is based on biopsy, but who knows.

I admit I haven't done a comprehensive read-through of the LDN studies. One of Dr. B's complaints about the research is that the mechanism can't be described (although that's not a dealbreaker for other meds, I know) and the woman he spoke to, who I understand is considered the "lead" researcher, was giving her LDN patients Iron injections, which he says is counterintuitive if they're really in remission from LDN as claimed.

The above represents MY RECOLLECTION of a conversation with Dr. B at Boston Children's about the state of LDN research, and therefore shouldn't be taken as his contribution, but mine. Just want to make that disclaimer.

They don't understand the mechanism for most of these medications. Even the biologics. If it's just the tnf inhibitor aspect of them, why did Enbrel fare so poorly in trials?

I live in a small town and have had the same GI for over 35 years. One would think, because of the small town status, that my doc may not be well versed in the latest and greatest relating to Crohns Disease. However, nothing could be further from the truth! I've been somewhat of a rogue patient the past 25 years. During my last flare a few years ago, my doctor started talking "top down approach" and it scared the crud out of me. I've been on Humira for almost 3 years now and love it! My Crohns is in remission and I seriously think I catch fewer illnesses now than prior to Humira...... even my sinus allergies are much better! When my 19 yr old son was recently diagnosed, I couldn't wait for him to start Humira and my son readily accepted it, in part because he sees how well I do on it.

When I had the battle with my insurance company to get approved for Humira, I was forced onto Asacol for a while. This is after I had a fistula repair and surgery.My GI referred to it as Pissin in the wind.

For many (most?) it probably is, but I'm a proud owner of a fistula myself (after a 7 year period of taking no meds at all), and 5-ASA, when I'm compliant, works great for me. So.. it's not totally worthless.

It shouldn't be up to your insurance company, though.

But then, for profit healthcare is immoral in the first place.

I can only mention from my personal experience. I had complications that lead me to see one of the best GI's in the world. This GI is known to start hard instead of easy. For example instead of starting out with the common drug or low power drug he'd start out with heavy duty biologics in my case with Methotrexate. I guess after evaluating your situation starting out heavy with biologics might be warranted. I heard David state a lot, "I likew hitting the disease from every direction hard." That might apply in your case.

David is correct now that you have Fistulating Crohns disease it is biologics from here on out. Take it from me you don't want to see what it will do to your intestines after 20+ years without the correct medication. You might simply not make it out of the surgery...its that serious. I like the conversation in this thread it was a great find and read! 5-ASA has been proven to work as David said on 555.1+555.2+555.9 because all of these Crohns diagnosis involve the large intestines. But don't be fooled 5-ASA is not a long term strategy if you have been diagnosed with Crohns, push on the bottom right of your stomach if there is even a small pain your Crohns is not under control and you are just doing damage to your intestines when you should be hitting it harder before they have to remove a large amount of your intestines.

I agree you absolutely should go to the biologics at this time. I too have some medical background, and as a result I am very cautious about side effects of medications. So when I was diagnosed with Crohn's 18 months ago I too resisted my GI's advice to go on stronger meds, because my symptoms "weren't that bad." But a fistula is pretty serious, and there is very strong evidence that biologics are in many cases the most effective treatment.
The other good news is that when I did start feeling fatigued enough to agree to Humira, it almost completely cleared up my symptoms within 2 months. And I have had no opportunistic infections, in spite of working in the health care field. I'm not saying your fistula will close that quickly, but I am saying that the side effects for you may be minimal. Good luck!