Monday, June 26, 2017

Patients’ Perspectives Concerning a Shift to Biosimilars at the 2017 EULAR Annual Meeting in Madrid




I have already looked at biosimilars at the 2017 EULAR Annual Meeting in Madrid [1]. But we have less data on the patients’ perspectives. Luckily the Danish Rheumatism Association shared experiences at the meeting.

L.M. Thomsen presented [2]: “PATIENT SAFETY IN RELATION TO BIOSIMILARS – HOW CAN WE ACT AS A PATIENT ORGANIZATION?” Changing from originator drug to biosimilars “caused considerable insecurity among the patients, who were afraid of biosimilars and their effectiveness and safety profile.” The Danish Rheumatism Association participated in a national plan for better monitoring and information about biologics and biosimilars: “1) Monitoring biological drugs and biosimilars on batch level, 2) Information campaign to health professionals and patients, 3) Digital solutions and easy reporting of side effects from health professionals and patients, 4) Focus on monitoring patient safety by the authorities.”

I had already referred to B. Glintborg and colleagues, who presented the following study [3]: “PRESCRIPTION PATTERNS OF BIOLOGICAL DISEASE MODIFYING DRUGS AND BIOSIMILARS IN ANKYLOSING SPONDYLITIS – A COLLABORATION BETWEEN BIOLOGICAL REGISTERS IN THE FIVE NORDIC COUNTRIES”. Conclusions: “The use of bsDMARDs in AS is rapidly increasing. …”. The interesting part is the picture. If an infliximab biosimilar is introduced, one would assume that originator infliximab is prescribed less frequently. That happened, but at a slower rate than expected. Also the etanercept biosimilar soared up after introduction. Interestingly this has led to a reduction in prescribing not only of etanercept originator but also of the infliximab biosimilar. But a strange thing happened – the rate of prescriptions for adalimumab, golimumab, and certolizumab decreased rapidly in the wake of the introduction of biosimilars; the drop even accelerated after the launch of the etanercept biosimilar.
In 2014 a total of 1164 patients had been treated with either originator biologics or biosimilars, in 2015 the number reached 1338 patients, and in 2016 the total number dropped to 1165 patients.

When changing to biologics, we like to save money and treat more patients. But the opposite happened. It might be the reflection of anxiety and insecurity about effectiveness and safety of biosimilars on the side of the patients, but on the side of prescribing rheumatologists it might reflect uncertainties in the vicissitudes of reimbursements and information policies. Is a shared decision between patient and rheumatologist still possible or have other forces already driven wedge in between the two?


Links and References:
[2] DOI: 10.1136/annrheumdis-2017-eular.3716
[3] DOI: 10.1136/annrheumdis-2017-eular.1891

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Peptidyl Arginine Deiminase 4 and Rheumatoid Arthritis at the 2017 EULAR Annual Meeting in Madrid




Peptidyl arginine deiminase type 4 (PADI4) converses arginine residues to citrulline [1]. PADI4 is normally expressed in the cytoplasm, nucleus and in cytoplasmic granules of eosinophils and neutrophils. And, now we become vigilant, PADI4 is also expressed in rheumatoid arthritis synovial tissues.

There had been just one study at the 2017 EULAR Annual Meeting in Madrid addressing peptidyl arginine deiminase 4 (PADI4).

K. Yamamoto presented [2]: “PEPTIDYL ARGININE DEIMINASE 4 AND RHEUMATOID ARTHRITIS: FROM HUMAN GENETICS TO MURINE MODELS”. The idea is that increased PADI4 is associated with increased citrullinated proteins like ACPA. PADI4 polymorphisms highly predispose male smokers to rheumatoid arthritis. As “the mechanisms of PAD4 involvement turned out to be more complex than previously thought in animal models”, PADI4 knockout mice were created to investigate the pathological process in detail. Dr. Yamamoto sees different roles for PADI4 in the immune system, when he compared neutrophil extracellular traps (NETs), which rewuire PADI4 to be generated, in rheumatoid arthritis and systemic lupus erythematodes.

So we see the advent of more basic research to elucidate the pathogenesis of inflammatory rheumatic diseases.


Links and References:
[2] DOI: 10.1136/annrheumdis-2017-eular.7136

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Immunogenicity and Anti-Drug Antibodies to Biologics at the 2017 EULAR Annual Meeting




ADA (anti-drug antibodies) are probably less of a problem than thought of before - at least in rheumatology. In the discussion during a workshop at the 10th TNF-alpha Forum in Munich (January 2017) [1] we found that ADA are significantly more important in gastroenterology and that gastroenterologists measure ADAs quite regularly. The workshop has been able to answer many questions, but also raised new ones. For example, we have to evaluate how useful measuring ADAs is in rheumatology. Let’s look at the 2017 EULAR Annual Meeting.

A. Gils talked on [2]: “IMMUNOGENICITY OF BIOLOGICS IN INFLAMMATORY BOWEL DISEASES”. Dr. Gils talked about correlations between through concentration of infliximab, adalimumab, golimumab, vedolizumab and clinical outcome. In gastroenterology “optimal therapeutic windows have been defined for both infliximab and adalimumab”. Immunogenicity is the capability of biologicals to elicit non-neutralizing or neutralizing anti-drug antibodies. He concluded: “Combining therapeutic drug concentrations and anti-drug antibody concentrations with relevant patient, disease and drug information will lead to optimal dosing of patients aiming at optimal clinical, biochemical and endoscopic outcomes.”

J.W. Bijlsma gave a talk on [3]: “AS A RHEUMATOLOGIST, DOES IT HAVE ANY CONSEQUENCE IN MY DAILY PRACTICE?” Dr. Bijlsma has no need for measuring ADAs in practice as the “consequences are zero: when the patient is not responding to the given drug anymore, I need to adapt the treatment”. And: “Would the presence of anti-drug antibodies influence my decision? No, there is no cross-reactivity to other biologicals (even from the same class of action), except to its biosimilar (underscoring that it is a real biosimilar!).” With drug-trough levels, it’s another story; these are tested in rheumatology, but it’s too early for a final decision on this topic. He stressed, that “with a look at cost-effectiveness this will certainly become relevant”.

What can we take out of these two talks? Though gastroenterology and rheumatology share the same drugs, our patients have different needs. ADAs in rheumatology are useful in science and need not be measured in daily practice. Drug-trough levels might become a hot topic in individualizing dosage of biologics.

Links and References:
[2] DOI: 10.1136/annrheumdis-2017-eular.7210
[3] DOI: 10.1136/annrheumdis-2017-eular.7118

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Curmil (Curcuma haltiges Getränk)




Ich hatte bereits mehrfach über Curcuma berichtet [1,2]. Curcumin ist der orange bis gelbe Farbstoff, der im indischen Gelbwurz vorkommt. Curcuma (auch Kurkuma im Deutschen), Gelbwurz oder Turmeric kann man sich im Lebensmittelhandel besorgen. Und jetzt gibt es sogar ein Getränk mit Curcuma. Es heißt Curmil.

Ich bin darauf gestoßen, weil es in der Sommerausgabe des proveg Magazins erwähnt wurde. Proveg ist übrigens der neue Name von VEBU (Vegetarierbund). Vielleicht haben Sie schon einmal das von proveg vergebene V-Label auf Verpackungen gesehen; es wird zwischen vegetarisch und vegan unterschieden.

Curmil ist ein Mandelgetränk mit Curcuma und Vanille [3]. Es enthält darüber hinaus Agavendicksaft, Kokosöl und schwarzen Pfeffer, der die Aufnahme von Curcuma verbessern soll. Nicht enthalten sind: Laktose, Gluten, künstliche Aromen, weitere Zusatzstoffe, Emulgatoren oder Stabilisatoren.

Wenn es Ihnen schmeckt, warum denn nicht.
 
Links:

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Sammelsurium (153) 26.06.2017




Alter Raucher
Der alte Mann streift die Glut von der Zigarette ab und betritt die Bäckerei. Er stinkt nach kaltem Rauch, aber irgendwie passt es auch wieder zu ihm. Sein Gesicht ist ernst, ja etwas verkniffen. Sein Bart ist ungepflegt. Er geht mit seinem Kaffee für einen Euro nach draußen und zündet die Zigarette wieder an.

Mangelndes Bewußtsein
Da einzelne Zellen kein Bewußsein haben, können sie auch nicht wissen, mit welchen anderen Zellen sie kommunizieren. Die Sprache unter den Zellen gleicht eher einer ComputerSprache als einer natürlichen Sprache. Es müßte möglich sein SimulationsProgramme zu erschaffen. Fuzzy-Logic.

Woolworth
Ich ging bei Woolworth einkaufen; mache ich nicht oft. Dann traf ich auf einen Mann, der hatte sie nicht alle beisammen (et Schoss eruss, ne Ratsch em Kappes). Er drängelte, welchselte von Kasse zu Kasse -: und alle wurden schnellen abgefertig, wie auch z.B. ich, denn ich war nach ihm gekommen, aber ich war eher fertig. Er kaufte Klebeband, das sehr billig war, und das war er eben auch.

Ehre
Schütteres Haar und doch gar nicht so alt. Gebeugter Rücken. Er geht zum AbfallEimer und sucht darin nach Etwas. Sein T-Shirt trägt auf dem Rücken "Die Ehre!" -: wie traurig!

Musikalisch
Der Oboist vergeigte sein Solo, als ihm die Bratsche flöten ging. (Das Streichquartett - Münchner Lach- und Schießgesellschaft)

Gerlinde
Sie sagte, dass man sie auf der Schule Zenzi genannt hatte. Und sie wisse nicht warum. Wir aber wußten es sofort und schwiegen verkniffen.

Vivian
"Für uns, Vivian, für uns!" grölte sie aus dem Aufzug über den Kinderwagen hinweg. In ihr Handy.

Verletzung
"Ich hab ihm geschrieben - Du hast mich so verletzt, Jürgen!" schrie sie ihrem Begleiter zu. Sie fuhren Fahrrad.

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