SB5 or IMRALDI® at the 2017 EULAR Annual Meeting in Madrid

 

As of June 23^rd 2017 Biogen announced, that he Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for IMRALDI® (also known as SB5, an adalimumab biosimilar). Let’s have a look at this year’s EULAR Annual Meeting. There have been two publications.

J. Kay and colleagues presented [2]: “IMPACT OF ADALIMUMAB SERUM CONCENTRATION ON EFFICACY AND ASSOCIATION BETWEEN ANTI-DRUG ANTIBODIES AND SERUM CONCENTRATION: 24 WEEK RESULTS FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMILAR) WITH REFERENCE ADALIMUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS”. Conclusions: “The presence of ADA reduces Ctrough for both SB5 and ADL. In both treatment groups, almost all patients without detectable ADA, but only slightly more than half of patients with ADA, had Ctrough ≥1.274 μg/mL at week 24. Efficacy and ADA incidence were generally comparable between SB5 and ADL regardless of Ctrough level. However, patients with Ctrough ≥1.274 μg/mL generally experienced greater efficacy of both SB5 and ADL than that in patients with Ctrough <1 .274="" add="" ctrough="" data:="" g="" in="" let="" me="" ml.="" patients="" some="" span="" the="" with="">≥1.274 μg/mL groups SB5 patients achieved 32.9 % and ADL patients 43.2 % good EULAR response, SB5 patients achieved 32.9 % and ADL patients 45.2 % low disease activity, and SB5 patients achieved 20.8% and ADL patients 25.9 % remission. Doesn’t look very convincing to me.

J. Ghil and colleagues presented [3]: “USABILITY AND SAFETY OF SB5 (AN ADALIMUMAB BIOSIMILAR) PRE-FILLED SYRINGE AND PRE-FILLED PEN IN PATIENTS WITH RHEUMATOID ARTHRITIS”. Conclusions: “The injection site pain score of PFS and PFP was comparable with overall preference rate higher for PFP. Both PFS and PFP were well tolerated with similar safety profiles.”

I guess, we can agree that these two studies won’t have much impact on EMA’s decision. The decision will be made more on political than medical issues. I’m not a friend of biosimilars, but I know that I’ll have to prescribe Imraldi, if, yes if Abbvie is prudent enough to cut prices for Humira. But why should they act prudently? If you have the number-one prescribed biologic in the world (Humira), you don’t act prudently but haughtily. Pride comes before a fall.

Links and References:

[1] http://media.biogen.com/press-release/biosimilars/biogens-imraldi-adalimumab-biosimilar-candidate-referencing-humira-grantedb

[2] DOI: 10.1136/annrheumdis-2017-eular.3348

[3] DOI: 10.1136/annrheumdis-2017-eular.3350

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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.

Tocilizumab Monotherapy vs. Humira Monotherapy

In a head to head study tocilizumab monotherapy  has been studied against humira monotherapy. Tocilizumab showed significantly better results.
Here a link, ‏@RonanTKavanagh supplied: http://www.biospace.com/News/roches-actemra-beats-abbott-laboratories-drug-in/262875/Source=TopBreaking  
I'll put on the abstract, later.
One question in a pre EULAR session to this study has been, if one should discontinue methotrexate. Most agreed that one shouldn't introduce methotrexate at the same time, when you switch to tocilizumab, but not to discontinue methotrexate if the patient already is treated with methotrexate and toloerates it. There has to come a study, but until then one can only extrapolate.
Another problem might be the stronger reduction of inflammatory lab parameters. It was suggested to look at CDAI to rule out any interference by a stronger influende on these parameters by tocilizumab compared to humira.