Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5
Ankylosing spondylitis (AS) is a chronic, painful inflammatory disease that primarily affects the spine and sacroiliac joints, leading to stiffness, reduced mobility, and impaired quality of life. For many patients, first-line treatments like non-steroidal anti-inflammatory drugs (NSAIDs) or tumor necrosis factor inhibitors (TNFi) fail to provide adequate relief—or cause side effects that limit long-term use. A new Phase III study, MEASURE 5, offers hope for patients in China and beyond: secukinumab, a biologic that targets the inflammatory protein interleukin-17A (IL-17A), significantly reduces AS symptoms and maintains benefits for at least one year.
Led by Dr. Feng Huang of the Chinese People’s Liberation Army General Hospital and colleagues from 11 institutions (including hospitals in China, South Korea, the UK, and the Czech Republic), MEASURE 5 is a 52-week, randomized, double-blind, placebo-controlled trial designed to test secukinumab’s efficacy and safety in patients with active AS. The study focused heavily on Chinese patients—71% of the 458 participants were from China—reflecting a need for data tailored to this population.
How the Study Worked
Patients with moderate-to-severe AS (meeting modified New York criteria, with high disease activity scores) were randomly assigned to one of two groups:
- Secukinumab 150mg: 305 patients received weekly subcutaneous injections for the first 5 doses, then every 4 weeks.
- Placebo: 153 patients received identical-looking injections on the same schedule.
At Week 16, all placebo patients switched to open-label secukinumab to ensure ethical access to treatment. The primary goal was to measure ASAS20 response at Week 16—a widely used benchmark for AS treatment success, defined as a 20% improvement in 3 of 4 key areas (pain, function, inflammation, global disease activity) with no worsening in the fourth.
Key Results: Fast, Significant, and Sustained Relief
The study met its primary endpoint: 58.4% of secukinumab-treated patients achieved ASAS20 response at Week 16, compared to just 36.6% of placebo patients (p < 0.0001). For Chinese patients specifically, the gap was similar: 56% vs. 38.5% (p < 0.01).
Benefits grew over time. By Week 52:
- 76.1% of patients originally on secukinumab maintained ASAS20 response.
- 77.3% of placebo-switchers (who started secukinumab at Week 16) also achieved ASAS20 response—showing that even delayed treatment works.
Secukinumab improved nearly every measure of AS severity:
- ASAS40 response (a more rigorous 40% improvement): 43.9% vs. 17% at Week 16 (p < 0.0001).
- BASDAI scores (disease activity): A 2.8-point drop with secukinumab vs. 1.5 points with placebo.
- Quality of life: Significant gains in physical function (SF-36 PCS) and AS-specific quality of life (ASQoL).
Even patients who had failed TNFi (the standard biologic treatment for AS) benefited: 58.5% of TNFi-incomplete responders on secukinumab achieved ASAS20 at Week 16, compared to 35.5% on placebo.
Safety: No New Concerns
Secukinumab’s safety profile was consistent with previous studies. The most common side effects (experienced by ~68% of secukinumab patients vs. 60% of placebo patients) were mild to moderate:
- Upper respiratory tract infections
- Hyperlipidemia (high cholesterol)
- Nasopharyngitis (sore throat/nose)
Only 2.2% of patients stopped treatment due to side effects, and no new or unexpected safety signals emerged over 52 weeks. Rare serious events (e.g., uveitis, ulcerative colitis) were infrequent and resolved without long-term harm.
Why This Matters for Chinese Patients
AS affects an estimated 0.3–0.5% of the Chinese population—over 4 million people. While TNFi are effective for many, up to 40% of patients do not respond or lose benefit over time. Secukinumab offers a new option:
- It targets IL-17A, a key driver of AS inflammation that TNFi do not address.
- It works quickly (improvements seen as early as Week 1) and sustains benefits.
- It is well-tolerated, even in Chinese patients (who often have unique treatment needs).
The study’s focus on Chinese patients is critical: previous global trials included few Asian participants, leaving gaps in data for this population. MEASURE 5 confirms that secukinumab works as well in Chinese patients as in other groups.
Limitations to Consider
- Unbalanced groups: Most participants (71%) were Chinese, so results are most applicable to this population.
- No imaging data: The study did not use X-rays or MRI to measure structural damage—though patient-reported outcomes (e.g., pain, mobility) are highly relevant to daily life.
Conclusion
MEASURE 5 provides strong evidence that secukinumab 150mg is a safe, effective, and durable treatment for AS—including for Chinese patients who have struggled with other therapies. The results align with global trials (like MEASURE 1 and 2) but add much-needed data for a population historically underrepresented in clinical research.
For patients living with the daily pain of AS, this study is a step forward: a treatment that not only relieves symptoms but keeps working over time.
doi.org/10.1097/CM9.0000000000001099
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