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09-17-2018, 06:34 PM   #1
Maya142
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Study on Entyvio and Arthritis

Study on Entyvio and Arthritis

Abstract
Objectives
Vedolizumab (VDZ) blocks α4β7 integrin and is licenced for the treatment of IBD. It has been associated with mild SpA-related features, including sacroiliitis and synovitis. Herein we report a series of cases demonstrating the emergence of severe SpA-associated enthesitis/osteitis following successful IBD therapy with VDZ.

Methods
We evaluated 11 VDZ-treated patients with IBD across seven centres who developed severe active SpA and/or enthesopathy, with the aim of characterizing the VDZ-associated SpA or entheseal flares. Imaging features demonstrating particularly severe disease were recorded.

Results
De novo SpA developed in 9 of 11 patients and flare of known SpA in 2 patients, with 4 patients requiring hospitalization due to disease severity. Available data showed that one of seven cases were HLA-B27 positive. The median time from VDZ initiation to flare was 12 weeks, with IBD well controlled in 7 of 10 patients (no data for 1 patient) at flare. Severe SpA enthesitis/osteitis was evident on MRI or US, including acute sacroiliitis (n = 5), extensive vertebral osteitis (n = 1), peri-facetal oedema (n = 1) and isolated peripheral enthesitis (n = 3). Due to arthritis severity, VDZ was discontinued in 9 of 11 patients and a change in therapy, including alternative anti-TNF, was initiated.

Conclusion
Severe SpA, predominantly HLA-B27 negative, with osteitis/enthesitis may occur under successful VDZ treatment for IBD, including in subjects with prior anti-TNF therapy for intestinal disease.
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Mom of M (20)
diagnosed with Crohn's Disease at 16
Juvenile Idiopathic Arthritis at 12
Juvenile Ankylosing Spondylitis at 16

Mom of S (23)
dx with JIA at 14
Ankylosing Spondylitis at 18
09-17-2018, 09:00 PM   #2
Lady Organic
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Thank you,
but I also just found this... kind of contradictary results or I am confused? or the first study means that new severe onset of arthritis can occur under VDZ?
THis phenomenon can occur with HUmira and remicade as well, right?

''Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials.''

Background and Aims:

Extraintestinal manifestations (EIMs) such as arthritis/arthralgia are common in inflammatory bowel disease. We performed post hoc analyses of data from the GEMINI studies to evaluate the effect of vedolizumab, a gut-selective anti-trafficking agent, on arthritis/arthralgia.

Methods:

Sustained resolution of baseline arthritis/arthralgia, worsening of baseline arthritis/arthralgia, the occurrence of new arthritis/arthralgia, and the composite of new/worsening arthritis/arthralgia were evaluated. Cox modelling was used for time-to-event analysis. Influence of corticosteroid-tapering was also investigated.

Results:

In Crohn's disease (CD) patients, vedolizumab was significantly less likely than placebo to be associated with new/worsening arthritis/arthralgia (hazard ratio [HR], 0.63; 95% CI, 0.44-0.89). Similar incidences of sustained resolution of arthritis/arthralgia occurred with vedolizumab and placebo. In CD patients on corticosteroids at baseline, corticosteroid dose-decrease increased the risk of new/worsening arthritis/arthralgia (odds ratio [OR], 7.49; 95% CI, 3.50-15.97) regardless of treatment; and in those achieving corticosteroid-free status, arthritis/arthralgia was less likely with vedolizumab than placebo (HR, 0.14; 95% CI, 0.05-0.35). In ulcerative colitis (UC) patients, vedolizumab and placebo showed similar incidence of new/worsening of arthritis/arthralgia. In UC patients on corticosteroid at baseline, arthritis/arthralgia was more likely in those achieving corticosteroid-free status than in those continuing corticosteroids (HR 2.63 [95% CI 1.13-6.11]); and in those achieving corticosteroid-free status, incidence of arthritis/arthralgia was similar with vedolizumab and placebo.

Conclusions:

Vedolizumab therapy was associated with a reduced likelihood of new/worsening arthritis/arthralgia in CD and no increased incidence of these events in UC.
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''UC-like Crohn's'' (2001)
wrists + ankles arthropathies (2013)
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Diet: ''IBD-AID'' : http://www.nutritionj.com/content/13/1/5+ organic food only, Vitamin D + B12 shots
Past meds: prednisone 50mg, 5-ASA (pill, rectal), cortifoam, cortenema, Imuran, Purinethol, methotrexate.
09-18-2018, 10:16 AM   #3
Scipio
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These two papers are kind of contradictory, but they are not quite looking at the same thing. The first paper reports an increased incidence of SpA = spondylarthropathies. Which are forms of arthritis the most well-known of which is ankylosing spondylitis, and which are known to be strongly associated with having the gene for HLA-B27. This paper reports the rise of SpA in vedo patients that is not associated with HLA-B27, which is unusual.

The second paper is a retrospective analysis of the data from the vedo clinical trials that did not find an increased of arthritis in general and in fact found a decreased risk overall. But this was apparently analyzed for all forms of arthritis and not just for SpA. Depending on the numbers, it's possible that both things could be true. You could have an increased risk of a rare type of arthritis that gets buried when you ask the question in terms of all arthritis.

Another way that both could be true is that it may take longer exposure to vedo for the SpA to develop. If that were the case it might not be noticed in in the clinical trial but could appear in the general patient population after taking the drug for a couple of years longer than the trial ran.

Clearly this is an areas requiring further research.
09-18-2018, 10:39 AM   #4
Maya142
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My daughter had already been diagnosed with SpA long before she started Entyvio. She has AS, which like Scipio said, is a type of SpA. She is HLA B27+.

Her arthritis really flared once we started Entyvio. She was only on Entyvio for two months. At the time, we suspected it was the Entyvio but there was not enough research to be sure.

I have seen other case studies in which patients developed new onset SpA or if they already had SpA, it became worse while on Entyvio.

I think it is definitely something that patients on Entyvio should be aware of - if they develop joint pain, they should be seen by rheumatologists.

I posted this particular article in the Parents' section and someone made the analogy of Remicade induced Psoriasis - Remicade is used to treat psoriasis but sometimes it also causes psoriasis.

It is possible there are some patients whose arthritis gets better on Entyvio, but current research suggests that the opposite can happen too.
09-18-2018, 11:13 AM   #5
my little penguin
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We were told woth biologics what they are finding is that
When Some people who have a “hidden “(not yet dx ) condition typically an EIM
Certain biologics will unmask (bring it to the surface quickly )
And after the drug is stopped the extra disease is still there
Biologics don’t cause the disease per day
But can bring a dormant disease to become active

They are still learning

Ds is hlab27 positive and does have juvenile spondyloarthritis
But does not have AS and has not used Entivyio
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09-18-2018, 11:30 AM   #6
Maya142
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^Yes - we were actually told the same thing when my daughter was diagnosed with Crohn's. She had been on an anti-TNF which treats arthritis but does NOT treat Crohn's - Enbrel.

Prior to that, she was on Humira which was probably keeping both conditions in check. Once Humira stopped working, she was put on Enbrel, and within a few months, she had worse GI symptoms and we scoped and found the Crohn's.

She has had GI issues all her life, so I don't think Enbrel caused the Crohn's.
09-18-2018, 02:06 PM   #7
Lady Organic
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We were told woth biologics what they are finding is that
When Some people who have a “hidden “(not yet dx ) condition typically an EIM
Certain biologics will unmask (bring it to the surface quickly )
And after the drug is stopped the extra disease is still there
Biologics don’t cause the disease per day
But can bring a dormant disease to become active

They are still learning

Ds is hlab27 positive and does have juvenile spondyloarthritis
But does not have AS and has not used Entivyio
This would mean new onsets of seronegative SpA could or have also occured with IBD patients on Humira and Remicade? any data on this?
-thats my worst fear with biologics... to start the medication and to end up in a worst articular condition...
On the other end, I think there could be more chances that a biologic help my arthralgia condition.
09-18-2018, 04:52 PM   #8
Maya142
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To be clear, arthralgia is simply joint pain. It is NOT treated with biologics.

Arthritis is inflammation in the joints. You can have inflammatory arthritis which is treated with NSAIDs, MTX or biologics. Spondyloarthritis or Rheumatoid arthritis are types of inflammatory arthritis.

Or you can have osteoarthritis, which is "wear and tear" of the joints. It's usually treated with NSAIDs.

I have known people with IBD whom developed inflammatory arthritis while on Remicade/Humira. It is impossible to know whether they would have developed it anyway.

For what it is worth, I am pretty certain that my younger daughter would have developed IBD at some point during her life - she had GI symptoms for years before we scoped her and we had been discussing scoping her for years.

I don't think Enbrel "caused" her IBD - I think she always had a predisposition towards it and Enbrel just triggered a flare that was bad enough for us to get her scoped.
09-18-2018, 06:51 PM   #9
Lady Organic
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Thanks. I do have mild musculoskeletal inflammatory condition. Its been diagnosed in 2 of my ankles tendons this year and a few years ago in my upper arm joints -bilateral. So far, no medication has given a significant reduction of symptoms. I am hoping that Humira could be of an help if I go on it.
09-18-2018, 07:38 PM   #10
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SpA doesn't usually get worse with anti-TNFs - typically it gets much better. I wouldn't worry about anti-TNFs much but if your GI suggests Entyvio, then I would discuss these articles with him.

MTX is another options though it typically doesn't work as well for enthesitis (inflammation where the tendons/ligaments insert into the bones). Biologics are best for enthesitis.
09-18-2018, 07:59 PM   #11
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thx, its becoming clearer everyday that my choice of biologic would be Humira. MTX failed to help my joint condition, plus it did not maintain remission of my CD.
09-19-2018, 07:08 AM   #12
my little penguin
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Humira was great for ds JSpA
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