Tuesday, June 12, 2012

Back from EULAR 2012 in Berlin – refocussing



I’m back from the 2012 EULAR Meeting in Berlin. Here is some information on the topics I had been looking for:


1. Biosimilars
How far have we come? What will be on the market as alternative to existing products?
Celltrion will most probably launch an infliximab biosimilar in 2013.


2. Anti-CD-20 Monoclonal Antibody (like Rituximab)
Is ofatumumab still in the race? Unclear, I’ve seen no poster.

How about ocrelizumab? Unclear, I’ve seen no poster.

Both have been analyzed in:
[AB0572] META-ANALYSIS OF THE KEY RHEUMATOID ARTHRITIS (RA) DISEASE ACTIVITY ENDPOINTS IN PATIENTS TREATED WITH B-CELL DEPLETING THERAPIES
S. Menon, K. Barker, E. Peeva, I. Gourley, A. Heatherington. Research and Development, Pfizer Inc, Cambridge, United States

And veltuzumab? Unclear, I’ve seen no poster.


3. Co-Stimulation-Inhibition
Subcutaneous abatacept, when will it be available?
I have an idea about this.


4. Anti-Interleukin-6 Monoclonal Antibody (like Tocilizumab)
How far has BMS-945429 (ALD518), an anti-IL-6 monoclonal antibody, come? An alternative to tocilizumab? Can’t find an abstract!


And CDP6038, another anti-IL-6 monoclonal antibody? Can’t find an abstract!


Sarilumab, another anti-IL-6 monoclonal antibody, has already been in a phase 2 study last year, what’s new?
There are two studies:
[OP0023] SARILUMAB FOR THE TREATMENT OF MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS: RESULTS OF A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL STUDY
[OP0169] SARILUMAB FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS: RESULTS OF A PHASE 2, RANDOMIZED. DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL STUDY (ALIGN)
http://rheumatologe.blogspot.de/2012/06/sarilumab-news-from-eular-2012.html



Will still take a while. Here’s one of the studies:
[FRI0180] THE MUSASHI STUDY: COMPARISON OF SUBCUTANEOUS TOCILIZUMAB MONOTHERAPY VERSUS INTRAVENOUS TOCILIZUMAB MONOTHERAPY: RESULTS FROM A DOUBLE-BLIND, PARALLEL-GROUP, COMPARATIVE PHASE III NON-INFERIORITY STUDY IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS
http://rheumatologe.blogspot.de/2012/06/tocilizumab-at-eular-2012.html



Has LY2127399 (an anti-BAFF monoclonal antibody) been studied further? Didn’t find an abstract.
I did so later:

Has atacicept [works on BLys(B-lymphocyte stimulator) and APRIL (A PRoliferation Inducing Ligand)] shown new efficacy? There is a study on atacicept:
[THU0090] SAFETY AND EFFICACY OF ATACICEPT IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS FROM THE ATACICEPT FOR REDUCTION OF SIGNS AND SYMPTOMS IN RHEUMATOID ARTHRITIS TRIAL (III)



6. Anti-Lymphotoxin-alpha Monoclonal Antibody
Is MLTA3698A, an anti-lymphotoxin-alpha monoclonal antibody, still studied? Didn’t find an abstract.
I did so later.


7. Secukinumab (an Anti-Il17a Monoclonal Antibody)
Is secukinumab (AIN457), an anti-IL17A monoclonal antibody, still under study? There are 8 abstracts, here is one:
[THU0111] SECUKINUMAB TREATMENT IMPROVES ACR50, HAQ-DI AND EULAR REMISSION RATES IN PATIENTS WITH RHEUMATOID ARTHRITIS


8. Oral JAK-Inhibitor, “small molecules”, SYK-Inhibitor and others
The oral jak inhibitor tofacitinib (CP-690,550) will most probably attract most attention. When will the drug be available? There are 16 studies like:
[THU0152] HOW SHOULD THE PRIMARY ENDPOINT BE ANALYSED IN RHEUMATOID ARTHRITIS TRIALS WHICH MANDATE RESCUE PRIOR TO THE CLINICAL ENDPOINT? ANALYSIS OF THREE PHASE 3 TRIALS OF TOFACITINIB


GLPG0259, a MAPKAPK5 inhibitor, should be abandoned. Didn’t find an abstract.
Has AMAP102, an orally available 5-HT2 receptor antagonist been studied further in a phase 2 study as planned? Didn’t find an abstract.




Concerning fostamatinib (a SYK inhibitor), how far have we come during the past year?, pain, fatigue, and overall physical health status. There are three abstracts:
[THU0139] PHARMACOKINETICS OF FOSTAMATINIB IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION: A PHASE I STUDY


Do we have new data on the oral S1P lyase inhibitor LX3305 (LX2931)? Didn’t find an abstract.

A study small molecules / protein kinase inhibitors (PKI)


9. IL-1Ra-Receptor antagonist
New developments concerning anakinra?
There are 40 abstracts – I haven’t read one, yet!


10. Some further ideas after today's preliminary session (06.06.2012)
* SBI-087 is a SMIP (= small molecule immune pharmaceutical) binding to CD-20 – here is one study
[OP0024] SAFETY AND EFFICACY OF SBI-087 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS IN A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

* Sirukumab MAB against IL-6 – has 4 abstracts:
[FRI0181] SIRUKUMAB, A HUMAN ANTI-IL-6 MONOCLONAL ANTIBODY, IMPROVES PHYSICAL FUNCTION IN PATIENTS WITH ACTIVE RA DESPITE METHOTREXATE THERAPY: RESULTS FROM A 2-PART, PROOF-OF-CONCEPT, DOSE-RANGING, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY


* Mavrilimumab MAB against GM-CSF has four abstracts:
[FRI0182] PHARMACOKINETICS AND IMMUNOGENICITY OF MAVRILIMUMAB
ADMINISTERED SUBCUTANEOUSLY IN SUBJECTS WITH RHEUMATOID ARTHRITIS


* NKG2a - negative regulator of cell activation has seven abstracts:
[AB0071] CHARACTERIZATION OF NNC141-0100, A THERAPEUTIC ANTIBODY TARGETING INHIBITORY CD94/NKG2A RECEPTORS EXPRESSED IN INFLAMED JOINTS OF RHEUMATOID ARTHRITIS PATIENTS


* Cetrorelix - GnRH-antagonist one abstract:
[OP0202] CETRORELIX, A GONADOTROPIN-RELEASING HORMONE ANTAGONIST, SIGNIFICANTLY REDUCES TNF-ALPHA AND DEMONSTRATES EFFICACY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: A PROOF-OF-CONCEPT, DOUBLE-BLIND RANDOMISED TRIAL


* CCX354-C and CCX168, which are chemokin-inhibitors. CCX354-C better than expected, one abstract:
[OP0203] ORALLY-ADMINISTERED CCR1 ANTAGONIST CCX354-C IN A PHASE 2 RHEUMATOID ARTHRITIS STUDY
Also something on CCX168, one abstract:
[OP0204] CHARACTERIZATION OF THE NOVEL C5AR ANTAGONIST CCX168, A POTENTIAL THERAPEUTIC FOR ANCA-VASCULITIS, RHEUMATOID ARTHRITIS, AND OTHER AUTOIMMUNE DISORDERS


* Dekavil - fibronectin-A-chain connected to IL-10
One abstract:
[FRI0194] A PHASE IB CLINICAL TRIAL WITH DEKAVIL (F8-IL10), AN ANTI-INFLAMMATORY IMMUNOCYTOKINE FOR THE TREATMENT OF RHEUMATOID ARTHRITIS, USED IN COMBINATION WITH METHOTREXATE


* GLPG0634 - JAK1 inhibitor also one study:
[OP0263] EFFICACY AND SAFETY OF GLPG0634, A SELECTIVE JAK1 INHIBITOR, AFTER SHORT-TERM TREATMENT OF RHEUMATOID ARTHRITIS; RESULTS OF A PHASE IIA TRIAL


* A new DMARD is under way from Japan:

* On modified release prednisolone:


* Acronyms of studies in rheumatology:
http://rheumatologe.blogspot.de/2012/06/acronyms-of-studies-in-rheumatoid.html



I hope you liked this teaser – it will take a couple of weeks to work through this.

5. Anti-BAFF Monoclonal Antibody
How about subcutaneous tocilizumab?

1 comment:

  1. Wow, Danke für die kompakte Form!

    ReplyDelete