Ankylosing Spondylitis

February 19, 2018

Eli Lilly announced that Taltz (ixekizumab) met the primary and all key secondary endpoints in COAST-V, a Phase II study evaluating the safety and efficacy of Taltz for the treatment of ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA). COAST-V is a multicenter, randomized, double-blind, active and placebo-controlled 16-week study. The trial included a placebo arm and an active control arm (adalimumab) for comparison with placebo, and studied patients who had never received a biologic disease-modifying anti-rheumatic drug (bDMARD). Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS. Patients were required to have an established diagnosis of AS with active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and a total back pain NRS score ≥4. During the study, ixekizumab-treated patients received a starting dose of 80mg or 160mg, followed by one of two dosing regimens: either 80mg administered subcutaneously once every two weeks or 80mg administered subcutaneously once every four weeks. The COAST-V study will also evaluate the long-term efficacy and safety of ixekizumab in patients with AS up to one year

December 19, 2016

Janssen Research & Development issued results of a phase III trial of Simponi Aria (golimumab) in the treatment of active ankylosing spondylitis (AS). GO-ALIVE was a phase III, multicenter, randomized, doubleblind, placebo-controlled trial. Patients (n=208) were randomized one-to-one to receive Simponi Aria 2mg/kg at weeks zero, four and every eight weeks or placebo at week zero zero, four and 12, with crossover to Simponi Aria at week 16. In addition to meeting the primary endpoint of ASAS20 at week 16, all statistically-controlled secondary endpoints in the GO-ALIVE study were also met with statistical significance in comparisons of SIMPONI ARIA versus placebo at week 16 (p< 0.05). Major secondary endpoints evaluated at week 16 were ASAS40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) score, an indicator of a major clinical response, and change in Bath Ankylosing Spondylitis Functional Index (BASFI) score, which measures improvements in physical function. The study will continue through 52 weeks. Data showed that 73.3% of patients with active ankylosing spondylitis receiving Simponi Aria 2mg/kg achieved the study’s primary endpoint of at least a 20% improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at week 16, compared with 26.2% of patients receiving placebo (p≤0.001). Data from GO-ALIVE will be part of an upcoming submission to the FDA seeking approval of Simponi Aria for the treatment of AS.

December 1, 2014

Novartis reported results from the MEASURE 1 and MEASURE 2 pivotal phase II study of AIN457 (secukinumab) in ankylosing spondylitis (AS). MEASURE 1 and MEASURE 2 are multi-center, randomized, placebo-controlled studies. Statistically significant improvements in signs and symptoms of AS were achieved with secukinumab v. placebo at week 16, as measured by at least 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20). More than 60% of secukinumab 150mg treated patients achieved an ASAS20 response in MEASURE 1 (p<0.0001) and MEASURE 2 (p<0.001). This is in comparison to 28.7% and 28.4% of placebo patients who achieved an ASAS20 response in MEASURE 1 and MEASURE 2, respectively. Secukinumab 150mg treated patients experienced ASAS20 responses at week one in both studies (p<0.01, MEASURE1; p<0.05, MEASURE 2) and were sustained through 52 weeks of treatment. Additionally, statistically significant improvements in ASAS20 at week 16 with secukinumab 150mg were observed, compared to placebo (p<0.05) in patients who had not been previously treated with anti-TNF therapies (anti-TNF naïve). These data are expected to form the basis of joint regulatory submissions planned for 2015.

April 5, 2004

Celltech Group reported positive preliminary results from a phase III trial investigating CDP870 for the treatment of rheumatoid arthritis (RA). Results showed the study met its primary endpoint, determined by the number of subjects achieving a 20% reduction in the American College of Rheumatology score ACR20 at 24 weeks. A significant ACR20 response was seen at week 1 and was maintained for the duration of the study. The six-month study (Study 014) was designed to test the safety and efficacy of CDP870 in combination with methotrexate on signs and symptoms of disease over a six month period. They trial enrolled subjects who had active moderate to severe RA despite treatment with methotrexate and other disease modifying anti-rheumatic drugs. In addition, Celltech announced plans to develop CDP870 for new indications, such as psoriasis, psoriatic arthritis and ankylosing spondylitis.

November 10, 2003

Centocor and Schering-Plough reported positive results from a phase III trial investigating Remicade (infliximab), a necrosis factor alpha therapy for the treatment of ankylosing spondylitis (AS). Results showed that subjects achieved a higher reduction in signs and symptoms associated with their disease when treated with Remicade compared with placebo. Data showed that 61.2% achieved an ASAS 20 in the infliximab group, compared with 19.2% placebo. The multi-center, randomized, placebo-controlled, double-blind study called ASSERT (Anklyosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) enrolled 279 subjects at 30 sites in North America and Europe. Subjects were given Remicade monotherapy 5 mg/kg infusions at weeks 0, 2, 6, followed by infusions every six weeks. The primary endpoint was the proportion of subjects demonstrating a 20% or greater improvement in signs and symptoms as measured by the ankylosing spondylitis assessment (ASAS 20) at 24 weeks.