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More Surgery Complications in the Biologics Era?

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Posted 1/25/2019 4:31 PM (GMT 0)
Study Shines Light on Surgical Morbidity In Ulcerative Colitis
Patients with ulcerative colitis are more likely to require multiple operations to manage their disease and have worse surgical outcomes since the introduction of biologic agents, researchers have found.

The study, which appeared in the Annals of Surgery (2018;268:311-317), found that patients in the prebiologic era were about 40% less likely to experience a major event or complication of surgery, and more than three times less likely to experience a complicated hospital discharge. Although the reason for the difference is unclear, it may reflect the fact that patients who do not respond to biologic agents have severe disease that requires surgery.

“The study is a reminder to continue investigation into the impact of biologic therapy on postoperative outcomes, and how that potential risk can be modified,” said Seema Patil, MD, an assistant professor of medicine in the Division of Gastroenterology and Hepatology at the University of Maryland School of Medicine, in Baltimore, who was not involved with the research. “It is also an indication that patients benefit from a multidisciplinary approach to the management of ulcerative colitis, with close coordination of gastroenterologists and surgeons when surgical therapy is being considered.”


In 2005, infliximab became the first biologic agent to receive FDA approval for the treatment of ulcerative colitis. While early randomized controlled trials demonstrated that the drug may reduce the short-term need for surgery in patients with ulcerative colitis, 30% to 66% of those with the condition who take biologic agents ultimately require operative treatment. Studies conflict as to the impact of these agents on surgical outcomes, with some demonstrating worse outcomes and others finding no difference. To date, no study has examined long-term surgical outcomes in a large patient cohort.

For the new study, Jonathan Abelson, MD, a clinical research fellow in the Department of Surgery at NewYork-Presbyterian Hospital/Weill Cornell Medicine, in New York City, and his colleagues reviewed the medical records of 7,070 patients with a diagnosis of ulcerative colitis who underwent surgery for their disease from 1995 to 2013. Half of the patients were treated before 2005, and the other half underwent surgery between 2005 and 2013.


More patients underwent at least three surgical procedures after 2005 than before that year, according to the investigators (14% vs. 9%, respectively; P<0.01). An adjusted analysis showed that patients undergoing surgery after 2005 had a higher likelihood of major events (odds ratio [OR], 1.42), procedural complications (OR, 1.42) and nonroutine discharge (OR, 3.17) during the index admission. Similar trends for worse adjusted outcomes in patients initially undergoing surgery after 2005 were seen at 90-day and one-year follow-up, the researchers reported.

Dr. Patil said the new study was important, because it challenges gastroenterologists to consider the reasons for reported poorer surgical outcomes in the era of biologics. She noted that the findings show an association, not a causative effect, and that the actual medication history of the patients with poor outcomes is unknown. In addition, she said, the biologic era cohort was clearly sicker at baseline, with significantly more comorbidities and concomitant infection with Clostridioides difficile (formerly Clostridium difficile).

“It is important to note that biologic therapy has revolutionized our approach to the management of ulcerative colitis,” Dr. Patil said. “Patients who undergo colectomy these days are typically refractory to biologic therapy, and may therefore represent a more severe phenotype who may be more at risk for poor outcomes.”

—Kate O’Rourke
Gastroenterology & Endoscopy News
Posted 1/25/2019 4:50 PM (GMT 0)
I'm probably one of those listed in the statistics; I had my surgery at that hospital and was readmitted due to a blockage/kink (I really doubt mine was due to a biological). My GI had me off of biologicals 3 months prior to surgery.
Posted 1/25/2019 11:55 PM (GMT 0)
U Charlie we are on the same wavelength. I posted about this but didn't see your post.
Posted 1/26/2019 9:16 AM (GMT 0)
That would seem to point to IBD being of infectious origin...

Why else would biologics make it worse.
Posted 1/28/2019 2:41 AM (GMT 0)
There is no evidence biologics make UC worse. Less people are getting surgery because of biologics. Says so right in the article. The ones getting surgery nowadays are the worst of the worst.

SO nothing at all related to infectious origin. You are forcing that idea.
Posted 1/28/2019 11:36 AM (GMT 0)
I agree with DB. I also wonder if surgeries are being delayed while doctors wait for patients to fail all of the biologic options, leaving them in worse overall health when they undergo surgery. Another thing I'd like to see a comparison to other surgeries (non-GI) to see if there are more complications with all major surgeries. The article does not mention MRSA or other staph infections so I'm not sure if this was part of the criteria of "major complication." From an anecdotal perspective, in my quasi-medical related career, I encounter a staggering number of patients with MRSA infections from surgery. 10 years ago I barely knew what it was.
Posted 1/28/2019 1:30 PM (GMT 0)
From what I've read in the biologics era, patients going into a surgery are of healthier weight and overall in general than in decades prior to the advent of surgery.

Part of it might be earlier intervention in nudging patients into the surgery direction earlier and more firmly (a change made in medical recommendations for gasteroenteroligists a while back).

The other part might be additional medication options at least keep you healthier up to surgery (you might not achieve a remission, but you're able to live a bit better QOL than prior to the new med options).

It's curious why their is a stubborn 20-25% who ultimately need colorectal surgery. I think defining a disease based on it's symptoms (and not underlying cause) is a kinda bad idea that causes this. As maybe we are talking two different diseases entirely (those responsive to treatment and those not being different illnesses) with different treatment paths needed (the one we know and the one we do not know).
Posted 1/28/2019 3:49 PM (GMT 0)
The surgeon at Mayo that I had a consult with years ago told me that surgeries are more difficult for people who have taken biologics. He said something about the tissue being not as easy to work with because it gets spongy and soft.
If you need biologics to avoid surgery and have no other good options, I think they are still worth trying out though.
Posted 1/28/2019 5:01 PM (GMT 0)
There are many UCers who started on mesalamines and remained on them thru extended remission. Why not simply perform a study comparing surgery rates with these people compared with those who jumped into biologics. For that matter they could compare rates of other diseases including infections and cancer, since biologics suppress the immune system.

Of course the objection would be that those not requiring biologics probably had a less severe disease to begin with. Possibly. But if there is a substantial difference between those two groups, (patients on biologics vs patients on mesalamines only), then it would give pause to those doctors who choose to prescribe biologics to all their patients from the getgo without first seeing if mesalamines are sufficient for maintaining remission.
Posted 1/28/2019 6:41 PM (GMT 0)
Ok i just read one of the articles on this subject. It looks like the data were only taken from the US. I would be interested if there is the same trend outside the US where the insurance systems and protocols are different. The article also said the in-hospital death rate is 8%? That seems a bit high. I would like to see age-adjusted statistics too. If there are fewer surgeries on younger people due to them taking biologics which hold them in remission for a while, presumably that would skew the surgical population to older than in previous years, which would increase several risk factors.
Posted 1/28/2019 9:38 PM (GMT 0)
8% seems really high.
Posted 1/28/2019 10:28 PM (GMT 0)
I was reading this:
https://www.mdedge.com/gihepnews/article/172260/colon-and-rectal/surgical-outcomes-uc-worse-introduction-biologics
perhaps i am being dummy in understanding the stats...
Posted 1/28/2019 11:13 PM (GMT 0)
Hey John (iPoop), your comment: "I think defining a disease based on its symptoms (and not underlying cause) is a kinda bad idea that causes this", is so on the mark!
Of course, that is just where we're at now medically, but it's kind of why I hate the smugness and close-minded attitudes of most the gastro's I have dealt with.
Posted 1/29/2019 12:26 AM (GMT 0)

IamCurious said...
There are many UCers who started on mesalamines and remained on them thru extended remission. Why not simply perform a study comparing surgery rates with these people compared with those who jumped into biologics. For that matter they could compare rates of other diseases including infections and cancer, since biologics suppress the immune system.

Of course the objection would be that those not requiring biologics probably had a less severe disease to begin with. Possibly. But if there is a substantial difference between those two groups, (patients on biologics vs patients on mesalamines only), then it would give pause to those doctors who choose to prescribe biologics to all their patients from the getgo without first seeing if mesalamines are sufficient for maintaining remission.

No .. it would not give any pause. The more severe cases idea is most likely. The study you propose does nothing to get at this idea. Likely the only way to do the study you want is people on mesalamines who needed biologics, but could not get them because of TB or something. You need two group with equal need for surgery, and nothing really distinguishing who got biologics.

This whole notion that biologics somehow makes things worse is just wrong. Every author has began with acknowledging that biologics has revolutionized care. They prevent a lot of surgeries.
Posted 1/29/2019 12:39 AM (GMT 0)

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0210703 said...
Results

The proportion of IBD patients who visited ED was 12.3% in 2007, 9.7% in 2009, 8.3% in 2012, and 6.4% in 2014 (P = 0.002). The most common chief complaints were abdominal pain (66.9%) in Crohn's disease (CD) patients and hematochezia (36.5%) in ulcerative colitis (UC) patients. The hospitalization rate following ED visits was 47.2% in CD patients and 55.6% in UC patients (P = 0.100). Multiple-variable analysis showed that significant risk factors associated with hospitalization in CD were aggressive disease behavior (odds ratio[OR] 3.54, P = 0.017) and presence of steroid exposure (OR 2.35, P = 0.047). Elevated C-reactive protein (CRP) (>0.5 mg/dL) (OR 5.40, P = 0.016) was the only risk factor associated with hospitalization in UC.

Conclusions

The proportion of ED visits decreased from 2007 to 2014; there was no significant change in hospitalization rates. Disease behavior/presence of steroid exposure and elevated CRP were associated with hospitalization among CD and UC patients who visited the ED, respectively.

So, about 47% or IBD patients going to emergency get admitted, but the rate of IBD patients going to emergency has been cut in half. The numbers fell every year form 2007 thru 2014 and is now half of what it was in 2007.

The whole point of these articles is that planning for post-surgical care needs to be rethought as only the cases not responding to biologics are getting surgery. These are not articles about any potential harm of biologics, but about updating the norms pre-surgery advice and post-surgery planning.

The 1st step is not to misunderstand the article you are reading.
Posted 1/29/2019 2:25 AM (GMT 0)

DBwithUC said...
No .. it would not give any pause. The more severe cases idea is most likely. The study you propose does nothing to get at this idea. Likely the only way to do the study you want is people on mesalamines who needed biologics, but could not get them because of TB or something. You need two group with equal need for surgery, and nothing really distinguishing who got biologics.

This whole notion that biologics somehow makes things worse is just wrong. Every author has began with acknowledging that biologics has revolutionized care. They prevent a lot of surgeries.

I think you may have misunderstood what I am saying. I think we can all agree that biologics in general have more severe side effects than the milder mesalamines. In fact some biologics come with a “black box” warning.

And that there are some IBDers who can remain on mesalamines alone for long term remission.
But there are doctors out there who prescribe big gun biologics at the first sign of IBD for ALL of their patients even though some would have attained remission with the milder 5-ASAs. And it is best practices that once on biologics you will probably remain on them.

All I was saying is why not see if mesalamines are effective before escalating to higher meds. After all that is/was the common practice:

https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3264940/
Biologic agents and immunosuppressants are appropriate if patients have moderate-to-severe disease and have failed other standard therapies.

https://www.ncbi.nlm.nih.gov/pubmed/23470503
There is evidence that use of thiopurines and anti-tumor necrosis factor (TNF) agents is associated with an increased risk of lymphoma, particularly non-Hodgkin's lymphoma in patients with IBD.
Hepatosplenic T-cell lymphoma, although rare, also occurs with increased frequency in patients treated with thiopurines and anti-TNF medications, and young male patients with Crohn's disease appear to be at greatest risk.
Furthermore, thiopurines and anti-TNF agents are associated with elevated rates of nonmelanoma skin cancer in non-IBD and IBD patients, and anti-TNF agents may also increase the risk of melanoma.
Rates of abnormal cervical cytology may be elevated by the use of immunosuppressive agents in female patients with IBD.
Posted 1/29/2019 3:20 AM (GMT 0)

IamCurious said...
...But there are doctors out there who prescribe big gun biologics at the first sign of IBD for ALL of their patients even though some would have attained remission with the milder 5-ASAs. And it is best practices that once on biologics you will probably remain on them....

Which doctors do that?
Posted 1/29/2019 3:50 AM (GMT 0)
In the years i have been on here i have seen people who just got UC given biologics.Not very rare to have seen it. I have been on here a lot in last 18 months bc of surgery and have seen it not long ago.My main reason for not wanting to go on them is they lower your immunity.For people over say 55-60 thats not great.So i choose surgery over Biologics.Was on mesalamines for many many years and they prob helped
Posted 1/29/2019 3:54 AM (GMT 0)
For a person who presents with moderate-to-severe disease at diagnosis, yes.

But have you seen people here who were diagnosed with mild disease and still started on biologics from the outset?
Posted 1/29/2019 1:35 PM (GMT 0)

Beave said...
For a person who presents with moderate-to-severe disease at diagnosis, yes.
But have you seen people here who were diagnosed with mild disease and still started on biologics from the outset?

Not just moderate-to-severe disease but pediatric cases too. There are no 'generic' biologics so we are talking at least $2,000-$5,000 per month in maintenance costs. Besides oral mesalamines reinforced with rectal meds have been known to handle some of the more serious cases.

iPoop said...
Some gasteroenterologists are big proponents of a top-down approach of using the strongest medications first, especially in pancolitis cases and pediatric cases (hit UC hard and early to provide the best quality of life before UC has a chance to spread or increase in severity). Different schools of though, all equally valid, and it all depends on one's own philosophy.

Posted 1/29/2019 1:55 PM (GMT 0)
Lol well we know that IamCurious has an axe-to-grind against biologics as a whole, over his posts over the years. Not a slam, but an honest observation in many posts over a long time.

I would encourage biologic prescription to moderate to severe pancolitis cases that involve hospitalization as a first line treatment. Yes, pediatric cases should be given stronger treatment up front, to stop disease spread in extent and severity early before it happens, and give them the best quality of life and lowest CRC odds. Makes a lot of sense and is practiced widely. I don't think forced is correct, recommended treatment is better with the way. Certainly a doctor should also discuss doing bottom-up approach for those who want to. Good doctors explain options and work with folks.

Should everyone start on biologics? No, very mild cases should obviously start bottom-up-approach.

Talking about severe cases for biologics, those that are highest risk. It's all about risk versus benefit, high risk patients get the strongest treatments earlier, whereas low risk patients start with mild meds.
Posted 1/29/2019 3:43 PM (GMT 0)
I am sure the pharmaceutical industry would love mesalamine replaced by biologics. Some doctors are likely falling for pharmacy rep lobbying to get them to prescribe.

But there have also been studies (the ones I saw were pediatric) that looked at whether the meds ladder was the best or whether big-guns earlier was best. There has been some support for big guns earlier approach. This is not the final word. Long term consequences of any newer med (including biologics) and non-medical factors such as cost, will eventually give a clearer picture.

More research is needed about the timing for initiating stronger treatments.
Posted 1/29/2019 4:46 PM (GMT 0)
Most likely the newer patients I've seen on here that were prescribed Biologics were severe cases.Now i wonder my Dr first wanted me to try Humira in 2008-9 but in New York it was only precribed for Chrons not UC.Is Humira and Remi prescribed in all 50 states for both diseases??? I believe u can get Humira now in NY for UC
Posted 1/29/2019 9:28 PM (GMT 0)

IamCurious said...
Not just moderate-to-severe disease but pediatric cases too. There are no 'generic' biologics so we are talking at least $2,000-$5,000 per month in maintenance costs. Besides oral mesalamines reinforced with rectal meds have been known to handle some of the more serious cases.

Huh? What does pediatric or not have to do with disease severity? Two separate things.

There *are* generic biologics in a sense. Inflectra and others. Still pricey though.

Just because oral mesalamines w/ rectal meds have been known to handle *some* of the more serious cases doesn't mean they handle *enough* of the more serious cases to recommend their use in said cases. Medical practice is based on an aggregate of cases, not single cases or outliers.
Posted 1/29/2019 9:31 PM (GMT 0)

3timechamp said...
Most likely the newer patients I've seen on here that were prescribed Biologics were severe cases.Now i wonder my Dr first wanted me to try Humira in 2008-9 but in New York it was only precribed for Chrons not UC.Is Humira and Remi prescribed in all 50 states for both diseases??? I believe u can get Humira now in NY for UC

It's not the state, it's the insurance company, that dictates which biologic is covered first for UC or for Crohn's.

The FDA approved both for both diseases many years ago. Then it's up to individual insurance companies to determine which they will cover first.
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