Novartis Announces 52-Week Data from Phase III MEASURE 5 Study of Secukinumab in Chinese Patients with Ankylosing Spondylitis

Shanghai, September 21, 2020 /PRNewswire/ --September 19, 2020Novartis (China) announced the 52-week data from the Phase III clinical study (MEASURE 5 study) of secukinumab for the indication of ankylosing spondylitis (AS) in China. The results confirmed that secukinumab can rapidly and significantly improve disease symptoms and signs in Chinese patients with AS, and demonstrated favorable long-term safety and tolerability. The MEASURE 5 study is also the first randomized, placebo-controlled clinical study targeting interleukin-17A (IL-17A) inhibitors conducted specifically in Chinese patients with AS to date. Furthermore, it is currently the Phase III randomized, double-blind, placebo-controlled clinical study with the longest follow-up duration among biologic agents in Chinese patients with AS.

This Phase III clinical study enrolled a total of 458 patients aged ≥18 years with moderate-to-severe ankylosing spondylitis (AS), of whom 327 (71.4%) were from China. The study results showed that among all Chinese patients treated with secukinumab 150 mg, the ASAS20 response rate already demonstrated a statistically significant difference compared to the placebo group at Week 1; a significant difference in the ASAS40 response rate was observed at Week 2. At Week 16, the ASAS20 and ASAS40 response rates in the secukinumab group were 56.0% (placebo group: 38.5%) and 41.7% (placebo group: 16.5%), respectively, indicating that secukinumab can rapidly improve patients’ signs and symptoms. Moreover, significant efficacy was achieved regardless of prior use of TNF-α inhibitors.

Furthermore, the study results demonstrated that the clinical benefits of secukinumab were durable, with a trend toward further improvement as treatment duration increased. The 52-week results showed that among all Chinese patients treated with secukinumab 150 mg, the ASAS20 and ASAS40 response rates reached 77.3% and 60.5%, respectively, representing improvements over the 16-week results. Meanwhile, disease activity continued to decline, and quality of life continued to improve, confirming the durable efficacy of secukinumab in Chinese patients and its ability to sustainably alleviate disease symptoms. In terms of safety, the safety profile was generally consistent with previous studies, demonstrating favorable overall safety and tolerability of the drug.

Secukinumab has been marketed in numerous countries and regions, including Europe and the United States, with approvals for the treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. In 2020, secukinumab received sequential approvals in the European Union for two new indications: “radiographic-negative axial spondyloarthritis” and “moderate-to-severe plaque psoriasis in children and adolescents aged 6 to under 18 years,” further expanding its therapeutic scope and holding promise to bring health hope to more patients.

In China, secukinumab is currently approved for two indications: “for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy” and “for adult patients with ankylosing spondylitis who have had an inadequate response to conventional therapy.”

References: Chinese Medical Journal: 2020 - Volume Publish Ahead of Print-doi: 10.1097/CM9.0000000000001099

* Radiographic-negative axial spondyloarthritis,6To18The indications for moderate-to-severe plaque psoriasis and psoriatic arthritis in children and adolescents under the age of have not been approved in mainland China.

** This material is intended to convey cutting-edge pharmaceutical information and research progress, not for advertising purposes.