Wednesday, December 21, 2016

What’s in the names of drugs in rheumatology?

As soon as I see drug names, I associate something. What’s in the names of drugs in rheumatology? I’ll show you some associations. Maybe you have even more or others; feel free to post these. Drugs in rheumatology doesn’t mean that only approved drugs will appear here.

Abatacept – close to abattoir.

Arava – do you also see the colorful parrot? And Ava like Ava Gardner. Some patients call the drug avara, which is close to awaara (awaara hoon, Hindi for I am a vagabond).

Celebrex - Oh, a celebration!

Cimzia – like the Italian female name Cinzia. But as the drug was introduced to Germany we thought more of Zimtzicke (bitchy cow).

Etanercept – too bad, eta are the outcasts in feudal Japanese society. Eta (
穢多) means abundance of filth.

Guselkumab – looks a bit gruselig (creepy, gruesome). Or even like Gruselkabinett (chamber of horrors).

Humira – human, but the second half ira is Latin for wrath.

Lantarel – nobody could have expected, that later there’ll be a Lana del Rey. On the other hand lanta is Finnish for manure. Oops!

Leflunomide – Le flu comes to my mind, but in French it’s la gripe for flu.

Methotrexate – luckily people abbreviated methotrexate to MTX and not to Meth.

Orencia – I have called it Horrencia because of the high price and the German word horrend (horrendous). There also lies horror in the word.

Remicade – there is a tie or draw in the word because of remis.

RoActemra – in Germany tocilizumab is marketed as RoActemra and not as Actemra. Ro(che) acts on RA (rheumatoid arthritis). Good choice, but a but – ro in German means raw (roh).

Simponi – looks like symphony. The Supremes sang: “… I hear a symphony”. And that’s what you get, when you search on Twitter for instance, Indonesian or Malayan kids talking about simponi (songs, symphony). There’s even an Indonesian Pop band with the name Simponi.

… might be continued.

Tuesday, December 20, 2016

Rituximab Biosimilars




Where are the rituximab biosimilars? The patents on Rituxan or MabThera already have expired in Europe about three and a half years ago and in the US this September. Gabionline lists 23 rituximab biosimilar candidates at different stages. For instance Reditux has already been approved for the Indian market a long time ago. What’s keeping others from entering the markets?

There has been a study on Celltrion’s CT-P10 at the 2016 ACR Annual Meeting.  Chang-Hee Suh and colleagues presented [#1634]: “Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks”. Conclusions : “Pharmacokinetic equivalence was demonstrated in terms of AUC0-last [area under the serum concentration-time curve from time zero to the last measurable concentration], AUC0-inf [AUC from time zero extrapolated to infinity] and Cmax [maximum concentration after the second infusion] in the comparisons of CT-P10 to US-RTX [US-sourced innovator rituximab], CT-P10 to EU-RTX [EU-sourced innovator rituximab], and US-RTX to EU-RTX in RA patients. In addition, comparable safety profiles were observed among the 3 treatment groups.”
A second evaluation by Dae-Hyun Yoo and colleagues came under the title [#1635]: “Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks”. Conclusion: “CT-P10 showed highly similar efficacy, PD [pharmacodynamics] and safety profiles to reference products up to 24 weeks.”

A third abstract by Eugeniy Nasonov and colleagues brings us to interchangeability [#1639]: “Interchangeability of Innovator Rituximab and Its Biosimilar: Results from International Controlled Comparative 1-Year Study in Patients with Active Rheumatoid Arthritis”. Conclusion: “BCD-020 is highly similar to innovator rituximab in terms of efficacy, safety and immunogenicity. 1-year data show that switching between products does not affect treatment outcomes.” BCD-020 has already been approved in Russia in 2014 as AcellBia.

EMA has accepted GP2013, a rituximab biosimilar, for approval process in May 2016.

As of November 2016 Amgen is still recruiting for a phase 3 study on ABP798.

Boehringer stopped clinical development for its rituximab biosimilar BI 695500 in October 2015. Teva and Samsung also halted clinical development of their biosimilar rituximab candidates TL011 and SAIT101.

The list of 23 rituximab biosimilar candidates quickly dwindles if you consider the US and EU as markets. Most probably we’ll see an approval of CT-P10 and GP2013 in the near future. I don’t see an improvement of medical care, but I see possibilities for down pricing in the high end of anti-rheumatic drugs.

Links: 

Suh CH, Berrocal Kasay A, Chalouhi El-Khouri E, Miranda P, Bozic Majstorovic L, Jeka S, Hrycaj P, Rekalov D, Wiland P, Krause A, Szombati I, Mihailova A, Hospodarskyy I, Piotrowski M, Kwon SR, Lee EY, Yoo DH, Park W, Shim SC, Lee SJ, Kwon TS. Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/pharmacokinetics-and-safety-of-three-formulations-of-rituximab-ct-p10-us-sourced-innovator-rituximab-and-eu-sourced-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-from-phase-3-r/. Accessed December 20, 2016.

Yoo DH, Bozic Majstorovic L, Berrocal Kasay A, Chalouhi El-Khouri E, Irazoque-Palazuelos F, Cons Molina F, Miranda P, Shesternya P, Medina-Rodriguez FG, Wiland P, Jeka S, Garmish O, Hrycaj P, Rekalov D, Fomina N, Zisman D, Park YB, Kang YM, Suh CH, Shim SC, Lee SJ, Lee SY, Park W. Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-ct-p10-rituximab-biosimilar-candidate-and-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-from-phase-3-randomized-controlled-trial-over-24-weeks/. Accessed December 20, 2016.

Nasonov E, Mazurov V, Plaksina T, Nesmeyanova O, Knyazeva L, Eremeeva A, Chernyaeva E, Ivanov R. Interchangeability of Innovator Rituximab and Its Biosimilar: Results from International Controlled Comparative 1-Year Study in Patients with Active Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/interchangeability-of-innovator-rituximab-and-its-biosimilar-results-from-international-controlled-comparative-1-year-study-in-patients-with-active-rheumatoid-arthritis/. Accessed December 20, 2016.










Monday, December 19, 2016

The Very Basic Guide to Yiddish




Yiddish isn’t a dead language. In fact there are about 0.5-1.0 speakers. The book “Unorthodox” by Deborah Feldman encouraged me to write this very basic guide to Yiddish. Yiddish has been the lingua franca of the Ashkenazim (ashkenazic Jews) in middle and Eastern Europe. Like modern German Yiddish has its roots in medieval German. But it has an own grammar and lots of word come from Hebrew and other languages. Yiddish is considered a language of its own, being part of the continental West Germanic branch of Germanic languages like Afrikaans, Dutch, German, Letzebuergisch (Luxemburgish language). Some loan words from Yiddish are still in use in nowadays German. Yiddish has several dialects, with which we won’t concern ourselves in the very basic guide.

Thank you – a dank (pronounced donk) [German: Danke]
Thank you very much – a sheynem dank [German: Schönen Dank]
You’re welcome – nishto farvos
Yes – yo [German: Ja]
No – neyn [German: Nein]
Do you speak English? – redt ir English? (formal) redstu English? (informal) [German: would prefer sprechen to reden, but still correct is: Reden Sie Englisch? Redest Du Englisch?]
Please – zayt asoy gut [German: Bitte, but „Seien Sie so gut“ would still be possible]
Excuse me – entshuldik (for getting attention) [German: Entschuldigung?!]
Sorry – zay moykh
You’re welcome – nishto farvos
Good morning – gutn morgn [German: Guten Morgen]
Good evening – gutn ovend [German: Guten Abend]
Good night – a gute nakht [German: Gute Nacht]
Hello – sholem aleykhem
Hello (answer) – aleykhem sholem
See you later – biz shpeter [German: Bis später]
Goodbye – zay gezunt
Good luck! – zol zayn mit mazel!
How are you? – vi geyt es? [German: Wie geht’s?]
I’m fine! Thanks! – es geyt gut, a dank! [German: Mir geht’s gut. Danke!]
I would like to buy ... – ikh volt vi tsu koyfn ...
How much is it? – vi tayer iz dos? [German: Wie teuer ist das? But preferably: Wieviel kostet das?]
I like – mir gefelt [German: mir gefällt]
Please write it down – shrayb es on, ikh bet dikh
I don’t know – ikh vis nit [German: ich weiß nicht]
I don’t understand this – ikh farstey dos nit [German: ich verstehe das nicht]
Where is – vu iz [German: wo ist]
Where is the bathroom? – vu iz dos bodtsimer? [German: Wo ist das Badezimmer?]
I'm lost – ikh bin farloyrn
What is your name? – vi heystu? [German: Wie heisst Du?]
My name is LMK – ikh heys LMK [German: ich heisse LMK]
Mr, Mrs, Ms – her, froy, fraylin [German: Herr, Frau, Fräulein, but Fräulein hardly in use anymore]
Left – links [German: links]
Right – rekhts [German: rechts]
I need a doctor – ikh darf a doktor

Please blame any mistakes on me.

Links for Yiddish:

Links for more Basic Guides:
The Very Basic Guide to Turkmenian, Uzbek and Kyrgyz http://rheumatologe.blogspot.de/2014/10/the-very-basic-guide-to-languages-of.html

Winter to arrive soon




Abandoned seashore
Driftwood waiting in the wind
For geese to return


Window shopping
Huge stacks of calendars
Sparrow dashes off

Red morning
Red traffic lights
Coffee to go

Neon lights
Steps in the hallway
A welcome fly

Vicissitudes
Vacuity and vainness
A Ferris wheel
 
Frosty night
The moons shivers
And the fox


Out in the open
The wanderer is happy
Leaving steps in snow

 
Leave by leave
Rotting on the ground
But the white crane