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Surprising developments and trial outcomes revealed at EULAR 2019

18.06.2019

As part of our ongoing quest to monitor new trends and exciting developments in healthcare, Richard Hutchings (Senior Research Manager and immunology expert) attended EULAR 2019 (European Congress of Rheumatology) last week in sunny Madrid.

Richard attended a number of stimulating and interesting sessions, and shares his highlights, as well as what to look out for in the year ahead, in his blog below.

 

 

Upon entering the exhibition hall on Wednesday afternoon, it was clear that the rheumatology space is as competitive as ever – with the usual suspects (AbbVie, Pfizer et al.) joined by multiple biosimilar exhibitors (CellTrion, Amgen, Biogen, Gedeon Richter and Sandoz, to name but a few) and a widening array of indications on display.

Throughout the week we heard about interesting data and medical advances in Psoriatic Arthritis (PsA), Lupus, and more. However, interestingly, Rheumatoid Arthritis was not as clearly a ‘hot-topic’ area, as we’re accustomed to seeing in previous congresses.
On day one, we kicked off the conference with results presented from a large phase III trial in primary Sjögren’s syndrome – a disease with few current effective medications. Unfortunately, the news was negative, with abatacept failing to reach the primary endpoint (ESSDAI), despite showing an effect on the underlying immunology. We’re now looking ahead to see how GSK fare with a trial of belimumab in the same area later this year.

In the same session there were two exciting Systemic Lupus Erythematosus (SLE) studies presented: in the past, interleukins 12 and 23 had been implicated in the pathogenesis of SLE, and this has now been confirmed with a phase II study of ustekinumab (Stelara) in lupus nephritis, which achieved its primary endpoint (SRI-4 response at week 24). We saw additional analysis of the data in this session, including the reduction of BILAG flares seen as a result of treatment – one to watch in SLE over the next few years. Secondly, we saw long-term data on the sequential use of Benylsta and rituximab in SLE – showing impressive long-term outcomes. It was suggested that the two products have a synergistic effect, as after the initial rituximab dosing, Benlysta was shown to prevent long-term repopulation of B cells. The use of these two drugs could conceivably become a standard approach in the future.

 

The most exciting new data in PsA came through in Lilly’s symposia on day two. We attended the packed Thursday session which detailed ixekizumab’s superiority data in PsA versus adalimumab in the SPIRIT-H2H trial. Lilly’s product Taltz was significantly better on the primary endpoint metric (36% patients achieving ACR50 and PASI 100 simultaneously for ixekizumab versus 28% for adalimumab, at 24 weeks). Looking deeper into the data, the ACR50 scores alone are merely comparable (meaning that Taltz’s superiority derives from better efficacy in skin, rather than joints) but this still provides a convincing rationale to use the IL17 inhibitor preferentially in PsA. A second head-to-head study is planned for next year, and we look forward to hearing more about it!

 

 

Not to be outdone in PsA, Janssen presented an engaging symposium later the same day, focusing on the basic science behind their IL23 product guselkumab. The data in psoriasis has been impressive, including results showing a significantly higher PASI 90 response versus secukinumab at the one-year mark (although early response between the two is similar). Janssen have since reported positive topline results from the DISCOVER phase III studies for guselkumab in PsA, and we’ll likely see submissions for drug approval to the European Medicines Agency and US Food and Drug Administration later in the year. Additionally, a late breaking abstract from Sun Pharma showed positive phase II data from another IL23 – tildrakizumab – in PsA, meaning that Janssen won’t be the only company seeking approval for an IL23 in the future.

One interesting product in Rheumatoid Arthritis (RA) did catch the eye – we attended an abstract session on Friday where patient-reported outcome (PRO) data was presented for GSK’s GM-CSF product, from their phase IIb study. Interestingly, although this study’s primary endpoint wasn’t met (which had been previously reported), the PRO data was impressively higher than placebo, with positive results on patient-reported pain (VAS), as well as combined metrics such as CDAI and HAQ-DI. GSK are moving the product to phase III with different dosing, and we look forward to seeing how it fares.

If you would like to know more about EULAR 2019, please contact us info@hrwhealthcare.com.

HRW - Image of Richard Hutchings

 

 

 

 

 

By Richard Hutchings

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