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Joined: Jan 2004
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Very_Addicted_to_AS_Kickin
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http://ard.bmj.com/content/early/2015/03/20/annrheumdis-2014-206758.full

Conventional DMARDs in axial spondyloarthritis: wishfulrather than rational thinking!

Robert B M Landew1,2
+ Author Affiliations

1Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands
2Atrium Medical Center, Heerlen, The Netherlands
Correspondence to
Robert B M Landew, Amsterdam Rheumatology and Immunology Center, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands; landewe@rlandewe.nl
Received 3 March 2015
Accepted 8 March 2015
Published Online First 20 March 2015

Conventional synthetic DMARD (csDMARD) therapy in patients with axial spondyloarthritis (SpA) is a matter of continuous debate. Part of this discussion is a dispute about methotrexate (MTX) comedication in patients with axial SpA treated with tumour necrosis factor inhibitors biologicals (TNFi). The dispute seems to be based on perceptions rather than scientific evidence and may have been fuelled by one of the European League Against Rheumatism task force on the management of rheumatoid arthritis (RA) recommendations. This recommendation states that in RA, TNFi-biologicals should be used in combination with MTX,1 which finds its justification in the results of multiple randomised clinical trials and careful posthoc analyses thereof. (more...)

(-----------)

"Taken together, Lie's study is an example of an observational study in which residual confounding seems a far too likely explanation for the association between TNFi-retention and csDMARD comedication to justify implementation in clinical practice. However, absence of evidence for a particular hypothesis is not the same as evidence for the absence of such a hypothesis! The best experiment to test the hypothesis that csDMARDs in axial SpA improve TNFi-retention is the well-powered RCT that randomises patients with axial SpA to either monotherapy with a biological or to combination therapy of a biological plus a csDMARD, follow them blindly for some time and compare clinical efficacy, safety and drug-retention in both arms. Such a trial is feasible, but costly, hard to fund and unfortunately not in the interest of pharmaceutical industries. This may explain why this trial likely will not be performed in near future. That is truly a pity, since for the benefit of our patients and the affordability of our healthcare systems we urgently need unequivocal answers to simple but extremely relevant clinical questions."

Footnotes
Competing interests The author is the current president of ASAS.

cat

Full article available - free edition


MollyC1i - Riding OutAS
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Hey Molly,

Thanks for posting this. At a recent appointment, the rheumatologist brought up switching from celebrex to MTX as a middle of the road choice before I start Humira (also because of Humira's cost). I have more eye, energy complaints than spinal damage.

She said that she has fewer patients who suffer problems from MTX than with Celebrex, but all the studies I see on it are pretty dated. Perhaps as mentioned above, "it's not in the interests of pharmaceutical industries".

Jeff


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If you're in USA, many insurers require "step therapy" to determine whether you are resposive to lower cost meds before approving the expensive ones. NSAIDs and MTX are usually the first steps so perhaps that's what your Dr is doing. Not sure if that's required in Canada. The above quoted article is only relevant to the protocol of using TNFs with MTX. Best wishes



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Hi Jeff - you might find this useful - I had to smile at the final paragraph...!

UK Health Assessment Study: Older Drug Combos Equal TNF Drugs for RA

News | March 23, 2015 | Rheumatoid Arthritis, Musculoskeletal Citations
By Norman Bauman
Scott DL, Ibrahim F, Farewell F, et al. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial. BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h1046


Miossec P. Editorials: Drug treatments for rheumatoid arthritis: looking backwards to move forwards. BMJ 2015; 350 (13 March 2015) doi: http://dx.doi.org/10.1136/bmj.h1192

A UK study has found that that the older drugs are non-inferior to TNF inhibitors when methotrexate gave inadequate control of rheumatoid arthritis (RA).

Other randomized, controlled trials have concluded that the addition of sulfasalazine and hydroxychloroquine is non-inferior to the addition of tumor necrosis factor (TNF) inhibitors such as etanercept, although some rheumatologists say that those studies dont square with their personal experience. (See MTX Fails in RA. What Next? Reviewers Respond.)

The TNF inhibitors Against Combination Intensive Therapy (TACIT) study was funded by the UK National Institute for Health Research Health Technology Assessment.

In the TACIT study, 205 patients who were eligible for treatment with TNF inhibitors under current English guidance were randomized to either a TNF inhibitor first strategy or a combined disease modifying drug first strategy. For non-responders, additional drugs, including TNF inhibitors, were added after six months.

The TNF inhibitors were adalimumab, etanercept, and infliximab, following local practice. The most common TNF inhibitor was adalimumab and the most common drug combination was methotrexate and leflunomide.

The primary outcome was reduction in disability at 12 months, measured by a patient-recorded health assessment questionnaire (range 0-3), with a 0.22 non-inferiority margin. Baseline scores were 1.9 (TNF inhibitor first group) and 1.8 (combined drug group). The change in scores over 12 months was -0.30 (TNF inhibitor first group) and -0.45 (combined drug group). The mean difference was -0.14, which was below the prespecified non-inferiority margin.

The initial reductions were greater in the TNF inhibitor first group, which indicates the rapid onset of TNF inhibitors, but that difference disappeared by 12 months.

The editorial says that we should not call both treatments equally good; we should call them equally bad. Current treatment regimens start too late. If we were to follow the model of cancer treatments, we would combine drugs at the start of treatment and not wait for traditional monotherapies to fail.

---------------------- ##

alien (or mebbe one just sighs...!)


MollyC1i - Riding OutAS
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Hey Molly--yeah, both bad, both laughing and sighing. Thanks for all your articles you post. Very helpful when I don't have time for the long research sessions. wink

Snowshoe--it's kind of the same in Canada. Unless I pay or have a group drug plan (through work), I won't be able to get Humira.

I took from my rheumatologist's comments that MTX, when it works, either in conjunction or otherwise can be just as safe and efficient as newer drugs. In Canada, however, they've had shortages of MTX in the past because it's not profitable to make and there's less research being done on it due to the focus on newer biologics.


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Originally Posted By MollyC1i
Hi Jeff - you might find this useful - I had to smile at the final paragraph...!

UK Health Assessment Study: Older Drug Combos Equal TNF Drugs for RA

News | March 23, 2015 | Rheumatoid Arthritis, Musculoskeletal Citations
By Norman Bauman
Scott DL, Ibrahim F, Farewell F, et al. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial. BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h1046


Miossec P. Editorials: Drug treatments for rheumatoid arthritis: looking backwards to move forwards. BMJ 2015; 350 (13 March 2015) doi: http://dx.doi.org/10.1136/bmj.h1192

A UK study has found that that the older drugs are non-inferior to TNF inhibitors when methotrexate gave inadequate control of rheumatoid arthritis (RA).

Other randomized, controlled trials have concluded that the addition of sulfasalazine and hydroxychloroquine is non-inferior to the addition of tumor necrosis factor (TNF) inhibitors such as etanercept, although some rheumatologists say that those studies don�t square with their personal experience. (See MTX Fails in RA. What Next? Reviewers Respond.)

The TNF inhibitors Against Combination Intensive Therapy (TACIT) study was funded by the UK National Institute for Health Research Health Technology Assessment.

In the TACIT study, 205 patients who were eligible for treatment with TNF inhibitors under current English guidance were randomized to either a TNF inhibitor first strategy or a combined disease modifying drug first strategy. For non-responders, additional drugs, including TNF inhibitors, were added after six months.

The TNF inhibitors were adalimumab, etanercept, and infliximab, following local practice. The most common TNF inhibitor was adalimumab and the most common drug combination was methotrexate and leflunomide.

The primary outcome was reduction in disability at 12 months, measured by a patient-recorded health assessment questionnaire (range 0-3), with a 0.22 non-inferiority margin. Baseline scores were 1.9 (TNF inhibitor first group) and 1.8 (combined drug group). The change in scores over 12 months was -0.30 (TNF inhibitor first group) and -0.45 (combined drug group). The mean difference was -0.14, which was below the prespecified non-inferiority margin.

The initial reductions were greater in the TNF inhibitor first group, which indicates the rapid onset of TNF inhibitors, but that difference disappeared by 12 months.

The editorial says that we should not call both treatments equally good; we should call them equally bad. Current treatment regimens start too late. If we were to follow the model of cancer treatments, we would combine drugs at the start of treatment and not wait for traditional monotherapies to fail.

---------------------- ##

alien (or mebbe one just sighs...!)


Remember that RA and AS are not the same. This is about RA and not AS. TNF drugs work better in AS then they do in RA and the dmards really don't work at all in AS for the most part

Last edited by drizzit; 06/15/15 02:09 AM.

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