Trial results for the AScalate study (NCT03906136) investigating a treat-to-target approach versus standard-of-care (including an adalimumab-biosimilar) in axial spondyloarthritis were posted on ClinicalTrials.gov on 2025-04-16. The study found that at Week 12, the standard-of-care group achieved an ASAS40 response rate of 46.6%, compared to 34.0% in the treat-to-target group, suggesting the treat-to-target approach was not superior to standard-of-care.
Background
Adalimumab is a TNF inhibitor, widely used for inflammatory conditions. The AScalate study investigated treatment approaches for axial spondyloarthritis (axSpA), a chronic inflammatory disease primarily affecting the spine and sacroiliac joints. Patients in this study had active axSpA, were naïve to biological therapy, and had an inadequate response to prior non-steroidal anti-inflammatory drug (NSAID) treatment.
Trial design
The AScalate study (NCT03906136) was a Phase 3, randomized, parallel-group, open-label, multicenter study that enrolled 304 participants with active axial spondyloarthritis. The trial compared a treat-to-target (T2T) approach, which used secukinumab as a first-line biologic, against a standard-of-care (SOC) approach, which included an adalimumab-biosimilar. Participants were naïve to biological therapy and had an inadequate response to prior non-steroidal anti-inflammatory drug (NSAID) treatment.
Key results
The trial evaluated several efficacy endpoints, comparing the treat-to-target (T2T) approach to standard-of-care (SOC).
- For the "Percentage of Patients Achieving an ASAS40 Response at Week 12": The Treat-to-Target (T2T) group showed a response rate of 34.0%, while the Standard-of-care (SOC) group achieved 46.6%. Logistic regression analysis indicated an Odds Ratio (OR) of 0.59 (95.0% CI: 0.37 to 0.95) with a p-value of 0.029, favoring the SOC approach.
- For the "Percentage of Patients Achieving ASAS Partial Remission" at Week 12: The T2T group achieved 18.2%, compared to 29.0% for the SOC group. The OR was 0.55 (95.0% CI: 0.32 to 0.94) with a p-value of 0.029, also favoring SOC.
At Week 24, for "Percentage of Patients Achieving an ASAS40 Response", the T2T group achieved 40.1% versus 49.2% for SOC (OR 0.69, 95.0% CI: 0.43 to 1.1, p-value of 0.119). Similarly, for "Percentage of Patients Achieving ASAS20 Response" at Week 12, T2T had 51.8% versus 60.1% for SOC (OR 0.71, 95.0% CI: 0.45 to 1.14, p-value of 0.154). Other outcomes at Week 24, including ASAS20 response (T2T 62.1% vs SOC 65.3%; OR 0.87, p-value 0.562) and ASAS Partial Remission (T2T 22.8% vs SOC 28.5%; OR 0.74, p-value 0.264), did not show statistically significant differences.
What this means
The AScalate trial aimed to show superiority of a treat-to-target (T2T) approach (secukinumab first-line) over standard-of-care (SOC), which included an adalimumab-biosimilar. However, the results indicate that the SOC approach generally led to higher response rates for key efficacy measures like ASAS40 and ASAS Partial Remission at Week 12, with statistically significant differences. This suggests that the T2T strategy, as implemented in this study, did not demonstrate superiority and was, in some instances, less effective than standard-of-care for patients with active axial spondyloarthritis who were naïve to biologics.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03906136, titled "AScalate: Treat-to-target in Axial Spondyloarthritis," were posted on 2025-04-16 on clinicaltrials.gov.