Efficacy of secukinumab as first-line bDMARD vs standard-of-care
touchIMMUNOLOGY coverage of data presented at EULAR 2024:
According to international management guidelines, achieving remission or low disease activity in axial spondyloarthritis using the treat-to-target principle is a primary goal. However, with limited data comparing various treatment strategies for reaching this level of disease control, selecting the optimal first or second-line drug can be challenging. To address this, the Treat-to-Target in Axial Spondyloarthritis (AScalate) trial (NCT03906136) was designed to evaluate the efficacy of using the IL-17 inhibitor, secukinumab, as a first-line treatment compared to a standard of care approach.
The study results were presented by Prof. Denis Poddubnyy (Charité-Universitätsmedizin Berlin, Berlin, Germany) at EULAR 2024. In this interview, Prof. Poddubnyy provides insights into the rationale behind the AScalate trial, its unique design and methodology, and the key findings. We will also discuss the impact of these interesting results on clinical practice.
Questions:
- What was the rationale behind the AScalate trial and what were the studies objectives? (0.13)
- Could you provide a brief overview of the trials design and key endpoints? (1:17)
- What were the key findings and conclusions from the study? (3:06)
Associated abstract:
Poddubnyy D et al. Secukinumab versus standard-of-care in axial spondyloarthritis: a randomized controlled open-label trial for treat-to-target outcomes (AScalate). EULAR 2024. Abstract LBA0006
Disclosures: Prof. Denis Poddubnyy discloses receiving grant/research support from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; consulting fees from AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, and UCB; and speaker fees from AbbVie, Canon, DKSH, Eli Lilly, Janssen, MSD, Medscape, Novartis, Peervoice, Pfizer, and UCB.
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Transcript:
My name is Denis Poddubnyy. I’m a Professor of Rheumatology in Berlin at the Charité hospital, as of today.
When we planned the AScalate study, the treatment-to-target concept was around already, but there was no formal confirmation for the usefulness of this concept in daily clinical practice. And the second point was that according to the version, the active version of the ASAS-EULAR treatment recommendations, TNF inhibitors were recommended at the first line treatment option in patients who failed NSAIDs. Meaning, we wanted to generate information on secukinumab as a first line, biological treatment option, and to compare it to a strategy, which would imply use of, TNF blockers as a first line biological treatment option. At least, we have assumed that this would be the case in a standard of care group.
The design of the AScalate study was a little bit unusual. We recruited patients with axial spondyloarthritis, with active axial spondyloarthritis, who had failed, at least to NSAIDs and were randomized patients in one of two arms. The first arm was the treat-to-target arm. In this treat-to-target arm, we used, in the first phase, secukinumab 150 milligram. It was for 12 weeks. In the second phase for non responders, that was defined as non-achievement of the others, clinically important improvement. The treatment was escalated to secukinumab 300 milligram. That was continued for another 12 weeks. And then at week 24, for non-responders to secukinumab 300 milligram, there was an possibility to switch treatment to adalimumab, given a standard dose of 40 milligram, subcutaneously every two weeks.
In the second arm, we applied the standard-of-care approach, meaning investigators were asked to treat their patients routinely and no specific instructions were given to this patient group.The primary endpoint of this study was ASAS40 response at week 24. But we, of course, looked also at deeper responses, including remission at all three key time points, meaning week 12, week 24 and week 36.
The main finding of this study was that at none of the time points, the treat-to-target strategy using secukinumab as first-line treatment option followed by adalimumab, was better than standard of care approach. In the standard of care arm, doctors applied as expected, the strategy with TNF blockers, as first-line treatment in the majority of patients. Roughly 10 percent of patients received an IL-17 inhibitor at the first instance. And there were some switches.
It might be disappointing at the first glance that we couldn’t achieve the primary endpoint, but I see this study results in a positive way. It seems to me that, the treatment, according to the treat-to-target principles, is already in daily clinical practice. And that also means that in most of the cases, we treat our patients with axial spondyloarthritis sufficiently. So, following current treatment guidelines, for the treatment, for the management of axial spondyloarthritis is very likely associated with the best possible outcome for our patients. And it probably doesn’t matter which drug you take, TNF blocker, IL-17 blocker. Nowadays, it could be even a JAK inhibitor.
Interviewer/Editor: Gina Furnival
Cite: Poddubnyy D. Efficacy of secukinumab as first-line bDMARD vs standard-of-care. touchIMMUNOLOGY, July 25 2024.
