Wednesday, January 6, 2016

Carpe Diem Haiku Tokubetsudesu No. 64 Beyond "movement"


With the prayer mill
Pilgrims walk around Jokhang
Holy smoke rising

 

Butter lamps lighting
The dark halls of the temple
Pilgrims keep moving

 

Holy smoke rising
In front of busy Jokhang
Pilgrims prostrating



Tuesday, January 5, 2016

Fish oil in knee osteoarthritis?


“Fish oil in knee osteoarthritis?” is an interesting question. I’ve already mentioned a study here on this blog:
Fish oil and knee OA
Poster #2147: Fish oil doesn't have an effect on structural progression of knee OA. They used 9 g, which would be 18 cps. in Germany.
29.10.2013

The researchers sit predominantly in the area of Adelaide (University of Adelaide) and I’ve been in contact with them. In different groups they research fish oil in rheumatoid arthritis and other diseases.

Now, they’ve published two year data on Fish oil in knee osteoarthritis (OA). 202 patients with knee OA were randomised 1:1 to high-dose fish oil (4.5 g omega-3 fatty acids) 15 ml/day or low-dose fish oil (blend of fish oil and sunola oil; ratio of 1:9, 0.45 g omega-3 fatty acids) 15 ml/day. “The primary endpoints were Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score at 3, 6, 12 and 24 months, and change in cartilage volume at 24 months. Secondary outcomes included WOMAC function, quality of life, analgesic and non-steroidal anti-inflammatory drug use and bone marrow lesion score.” Results: “…the low-dose fish oil group had greater improvement in WOMAC pain and function scores at 2 years compared with the high-dose group …” Other endpoints didn’t reach statistical significance. The authors concluded: “In people with symptomatic knee OA, there was no additional benefit of a high-dose fish oil compared with low-dose fish oil. The combination comparator oil appeared to have better efficacy in reducing pain at 2 years, suggesting that this requires further investigation.”

Maybe, maybe not. The study didn’t have a placebo arm. Maybe omega-3 fatty acids like in fish, fish oil or flax oil will have a place in the treatment of rheumatoid arthritis or other auto-inflammatory diseases, but knee osteoarthritis might not benefit. However, I don’t want to sound too apodictical – please go on with your research.

References:

CL Hill et al.: Fish oil in knee osteoarthritis: a randomised clinical trial of low dose versus high dose. Ann Rheum Dis. 2016 Jan;75(1):23-9. doi: 10.1136/annrheumdis-2014-207169. http://www.ncbi.nlm.nih.gov/pubmed/26353789

Carpe Diem Haiku No. 891 joy of living


Into the marshlands
The wanderer bursts with joy
White herons fly up


Sprawling green pasture
Grass drilling through the harsh ground
Sparrows flying by


Monday, January 4, 2016

Biomimics


What are biomimics, you might ask. I did the same thing. Well, with the proliferation of biosimilars, we should be able to tell the one from the other.

Dr.Martínez (@MtzReuma) already has tweeted about a year ago: “… Biosimilars are NOT "biomimics" (AKA intended copies) …” (https://twitter.com/mtzreuma/status/569270634057871360). I won’t leave you with this statement though it already tells you what biomimcs are, but I’ll try to go a little deeper in the subject. “Biomimics, also known as intended copies, are non-originator biologicals that have received marketing approval before biosimilar regulations were put in place. They are currently available in some Asian and Latin American countries.” Link: http://www.gabionline.net/layout/set/print/Biosimilars/Research/Approval-of-biosimilars-in-rheumatology.

Yisaipu (益赛普) is an etanercept biomimic from China which is also sold as Etanar/Etart/Etacept in Colombia, Mexico, and India. Yisaipu wasn’t compared to innovator Etanercept. Infinitam is another etanercept biomimic, manufactured and marketed by Probiomed, a Mexican company.
Reditux® is biomimic marketed by Dr Reddy's Laboratories in Bolivia, Chile, India, Iran, and Peru; Wikipedia uses the classification as a “non-comparable biologic (NCB) version of rituximab”; link: https://en.wikipedia.org/wiki/Reditux. Also marketed in Paraguay by Farmasa as Tidecron®. Kikuzubam®, another biomimic of rituximab, is marketed by Probiomed in Bolivia, Chile, Mexico, and Peru.

A biosimilars must demonstrate equivalent efficacy and safety in head-to-head clinical studies with the originator biological. Biomimics fail to prove biosimilarity. Maybe Reditux® could prove to be a biosimilar to originator rituximab, but hasn’t done so as it has been approved in 2007 in India and won’t try to go to European or Northern American markets; until then it should be called a biomimic (I wouldn’t use the term “non-comparable biologic (NCB)”).

Take away message: Biomimics, also known as intended copies, are non-originator biologicals, that failed to prove biosimilarity.


Link:
Gilberto Castañeda-Hernández and colleagues: Biosimilars in rheumatology: what the clinician should know. http://rmdopen.bmj.com/content/1/1/e000010.full



Sunday, December 20, 2015

Carpe Diem Haiku No. 883 journey through the rough north of Honshu: a rough sea; in one house



Water gushing down
Stones clatter in the ravine
Lovers in slumber

 

Walking at the shore
The stones calm, not trembling
Soon the flood rolls in

 


Weihnachten und Frühling


Dieser Tage kam die Meldung, dass die Haselnusspollen so aktiv sind wie sonst im April. Heute gehe ich durch Köln und Meerbusch und es sieht nach Frühling aus. Auch von der Temperatur her. Ich habe einige Fotos geschossen:




Weidenkätzchen




Ich gebe zu, diese Blüten machen nicht viel her




Dafür diese frischen Efeublätter




Oder diese Blüten, die so herrlich duften



Die KVB hat alles neu gemacht, sieht also nach Winter aus



Also so einen Vorfrühling beschrieb ich 2014 hier:
Early spring in the Rhineland / 莱茵兰春早
http://rheumatologe.blogspot.com/2014/02/vorfruhling-im-rheinland.html?spref=tw

Und im letzten Jahr sah es so aus:
Spring is approaching
http://rheumatologe.blogspot.com/2015/02/spring-is-approaching.html?spref=tw

Aber bislang war es zwischendurch immer Winter gewesen. Das aber kann es ja noch werden.
.


Nachträge zum Jahreswechsel (05.01.2016):



In der Eifel, wo es sonst sehr, sehr kalt ist



Auch in der Eifel

























Aber das ist in Köln