Novartis announced new long-term Scapho (secukinumab) data for patients with Ankylosing Spondylitis (AS). This study is unique as these data show, for the first time with any biologic, that almost 80 per cent of AS patients treated with Scapho have no radiographic progression (mSASSS <2) of the spine at 4 years.

The new data also confirm sustained improvement in signs and symptoms in almost 80 percent of patients, while Scapho delivers a favourable and consistent safety profile. The new data was presented as a late-breaker during the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Diego, United States.

“Staying true to our philosophy of Winning for Patients, these data now give us an opportunity to fulfil the unmet needs of people suffering with ankylosing spondylitis. Chronic and disabling conditions such as these impact the productive years of people. With Scapho® we are now even more confident of offering patients an active life with enhanced mobility,” said Jawed Zia, Country president, Novartis India.

Recognizing these data findings as a pivotal milestone in treatment for ankylosing spondylitis, Dr. Jyotsna Oak, Consultant Internal Medicine and Rheumatology, Kokilaben Dhirubhai Ambani Hospital said, “Nearly 30 – 40 lakh people in India suffer from ankylosing spondylitis. It results in serious impairment of movement impacting the quality of life. Young working population is most commonly affected. It is important that the disease is diagnosed and treated at an early stage in order to control disease progression. This promising data boosts our confidence to improve outcomes in Ankylosing Spondylitis patients from a long-term perspective.”

These new long-term data add to a growing body of evidence demonstrating the unique position of Scapho with lasting efficacy and proven safety across AS, psoriatic arthritis (PsA) and moderate-to-severe psoriasis. Scapho is the first and only IL-17A inhibitor approved for AS. Scapho is a highly targeted biologic for first-line use in AS, a chronic inflammatory disease that can lead to prolonged pain and mobility loss.

Secukinumab is the first and only fully human IL-17A inhibitor approved to treat AS, PsA and psoriasis7. Secukinumab is a targeted treatment that specifically inhibits the IL-17A cytokine, which plays a significant role in the pathogenesis of AS, PsA and plaque psoriasis. Secukinumab is the first IL-17A inhibitor approved in more than 70 countries for the treatment of active AS and PsA, which includes the European Union countries and the US. Secukinumab is also approved for the treatment of PsA and pustular psoriasis in Japan.

Secukinumab is also approved in more than 75 countries for the treatment of moderate-to-severe plaque psoriasis, which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Secukinumab is approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients. In the US, Secukinumab is approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

In India, Secukinumab is known as Scapho, was approved for the treatment moderate-to-severe plaque psoriasis in October 2015 and for the treatment of AS and PsA in January 2017.


MEASURE 1 is a 2-year, multi-center, randomized, placebo-controlled phase III study assessing the efficacy and safety of Scapho in patients with active AS. A total of 290 of 371 patients completed the trial, after which 274 patients were invited to enter a 3-year extension period. Primary endpoints assessed superiority of Scapho against placebo at Week 16 in the proportion of patients achieving at least a 20% improvement in the ASAS 20 response (Assessment of Spondyloarthritis International Society response criteria). From Week 16, patients in the placebo arm of the study were re-randomized to Scapho 75 mg or 150 mg based on ASAS 20 response, with non-responders switched at Week 16, and responders at Week 241.

Of the patients participating in the study, almost 80 per cent demonstrated no radiographic progression over 208 weeks of treatment, as indicated by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) X-ray assessment measure1. Importantly, no structural progression of AS in the spine was paired with sustained results on patient-reported pain measures, with over 75 per cent preserving an ASAS 20 response at 4 years. The safety profile of Scapho was shown to be consistent with that seen in clinical trials across multiple indications.

AS is part of a family of lifelong inflammatory diseases that also includes PsA. It generally results in serious impairment of movement in the spine and physical function, which has an impact on quality of life. People in their teens and twenties, particularly males, are affected most often. Family members of those with AS are at higher risk.