BI 655066 (a humanized IgG1 monoclonal antibody) at the ACR 2015 meeting in San Francisco

P.J. Mease mentioned IL-23 as a target in psoriatic arthritis in an article in Current Opinion in Rheumatology (Curr. Opin. Rheumatol) and he stressed the importance of “having effective medicines with an alternative mechanism of action [, which] will improve our ability to diminish disease activity impact on patient lives.”

And recently I’ve read an article, titled: “Boehringer says anti-IL-23 drug beats Stelara [Ustekinumab] in psoriasis trial”, in which we’re told: “New data from a phase II trial of Boehringer Ingelheim's psoriasis candidate BI 655066 back up earlier results showing it is more effective than a rival drug from Johnson & Johnson.” Well, this article talks about psoriasis and not of psoriatic arthritis.

But I guess, you’re also interested in hearing more about this potential drug.

Kim Papp and colleagues presented a phase 2 study at the ACR 2015 Annual Meeting in San Francisco [abract No. 2144]: “Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis [PsA]”. (With and without!) BI 655066 is a humanizedIgG1 MAB, which selectively inhibits IL-23p19. “166 patients were randomly assigned (1:1:1:1 ratio) to receive subcutaneous injections of one of three dosage regimens of BI 655066 (18 mg single dose at Week 0; 90 or 180 mg at Weeks 0, 4, and 16), or ustekinumab (45 or 90 mg, based on weight, at Weeks 0, 4, and 16).” The primary endpoint of PASI 90 response at Week 12 was achieved by up to 81.0 of BI 655066 patients and 40.0% of ustekinumab patients. There were only 46 (27.7%) patients with PsA “(either previously diagnosed by rheumatologist [n=13] or suspected by investigator [n=33])”, who nevertheless showed a good pain reduction (VAS). Conclusion: “Selective blockade of IL-23p19 with BI 655066, in the 90 mg and 180 mg arms, were associated with PASI responses superior to ustekinumab in patients with moderate-to-severe plaque psoriasis. Treatment with BI 655066 or ustekinumab was associated with numeric improvement in pain-VAS in patients with diagnosed or suspected PsA. Further studies are needed to assess long-term efficacy and safety of BI 655066 in both psoriasis and PsA.”

I think in treating skin psoriasis dermatologist are beyond PASI90, so I’d call 81% achieving PASI90 good, but not outstanding. There were only 28% of patients with psoriatic arthritis in the study and furthermore only a very small number of the patient (N=13) of the whole cohort (N=166), which amount to a meagre 8% of patients, were properly diagnosed by a rheumatologist. There has been a pain reduction, but that isn’t enough to judge the efficacy of BI 655066 against signs and symptoms of psoriatic arthritis. As the authors stated: “Further studies are needed”. So, we have to wait for Boehringer to sponsor a proper study on psoriatic arthritis.

References:

Mease PJ Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis [abstract]. Curr Opin Rheumatol. 2015 Mar;27(2):127-33. doi: 10.1097/BOR.0000000000000147. http://www.ncbi.nlm.nih.gov/pubmed/25599143

Boehringer says anti-IL-23 drug beats Stelara in psoriasis trial - http://www.pmlive.com/pharma_news/boehringer_says_anti-il-23_drug_beats_stelara_in_psoriasis_trial_837989.

Papp K, Menter A, Sofen H, Tyring S, Lacour JP, Berner B, Bennett N, Aslanyan S, Flack M, Scholl P. Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-different-dose-regimens-of-a-selective-il-23p19-inhibitor-bi-655066-compared-with-ustekinumab-in-patients-with-moderate-to-severe-plaque-psoriasis-with-and-without-psoriatic-a/. Accessed February 11, 2016.

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