P248 Subcutaneous secukinumab 150 mg provides rapid and sustained relief in total and nocturnal back pain, morning stiffness and fatigue in patients with active AS over 4 years

Abstract

Background Ankylosing spondylitis (AS) is a chronic inflammatory condition with pain, stiffness and fatigue reported as the most troubling symptoms. Early and sustained relief of these symptoms is essential for effective management. Secukinumab provided sustained relief from pain and fatigue in AS patients over 2 years in the MEASURE 2 study. We report the effect of subcutaneous secukinumab 150 mg on key clinical symptoms (pain, morning stiffness and fatigue) in AS patients over 208 weeks in MEASURE 2. Methods This post-hoc analysis of MEASURE 2 assessed mean change from baseline to Week 208 in total and nocturnal back pain scores (by VAS [0-100]; ASAS outcome component), overall level of spinal pain (neck, back or hip) from BASDAI scores, and morning stiffness (overall level; mean of question 5 and 6 of BASDAI score). Additionally, the SF-36 physical component summary score, overall level of fatigue (BASDAI question 1), FACIT-Fatigue score and patients meeting minimal clinically important difference (MCID) criteria across multiple clinical domains were assessed. Data are shown for patients originally randomised to secukinumab 150 mg and placebo. Data are reported as observed for the overall population and by prior TNF inhibitor (TNFi) therapy status (naive vs inadequate response [IR]). Results Baseline characteristics were comparable across secukinumab 150 mg (N = 72) and placebo (N = 74) groups; total mean back pain score was 67.7±17.79, nocturnal back pain score was 64.9±19.58 and morning stiffness was 6.5±2.11. Secukinumab 150 mg-treated patients reported rapid and early reductions in pain scores by Week 4, which were sustained through Week 208 (Table 1). Improvements with secukinumab 150 mg were reported for all key clinical symptoms by Week 4, which were sustained at Week 208. A higher proportion of secukinumab 150 mg-treated patients met MCID criteria at Week 16 vs placebo across multiple clinical domains, which was sustained or further improved through Week 208. Improvements were observed in TNFi-naive and -IR patients, with a greater magnitude of improvement in TNFi-naive patients. Conclusion Secukinumab 150 mg was associated with rapid and clinically meaningful improvements in total and nocturnal back pain, morning stiffness and fatigue, with improvements sustained over 4 years of treatment. Disclosures H. Marzo-Ortega: Consultancies; AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Grants/research support; Janssen, Novartis. C. Miceli-Richard: Consultancies; Pfizer, Roche, UCB, Wyeth, Merck. Member of speakers’ bureau; Abbott, Bristol-Myers Squibb, Merck, Pfizer, Roche, Schering-Plough, Wyeth. Grants/research support; AbbVie, Bristol-Myers Squibb, Novartis, Merck, Pfizer, Wyeth. S. Gill: Consultancies; AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Amgen, Sanofi-Genzyme. Other; AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Amgen, Sanofi-Genzyme. M. Magery: Consultancies; Eli Lilly, Novartis. Grants/research support; AbbVie, UCB, Amgen. P.G.P. Machado: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. A. Shete: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. J. Wang: Other; Employee of Novartis. S. Rohrer: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. A. Deodhar: Consultancies; AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GSK, Galapagos, Janssen, Novartis, Pfizer, UCB. Grants/research support; Eli Lilly, GSK, Novartis, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, UCB.

<p>Impact of Secukinumab on Patient-Reported Outcomes in the Treatment of Ankylosing Spondylitis: Current Perspectives</p>

“…26 At Week 16 in MEASURE 2, patients receiving secukinumab 150 mg had reported a decrease of 30.3 points from baseline for nocturnal back pain, versus a decrease of 10.1 for placebo (p < 0.0001). 26 This improvement was sustained through 4 years, regardless of prior anti-TNF therapy, 42 although the magnitude of improvement for both total and nocturnal back pain scores was greater in patients who were anti-TNF-naïve. 42 These data demonstrate secukinumab’s proven efficacy in treating back pain in AS, an important PRO.…”

“…', with the response given on a VAS from 0-2 or more hours Total and nocturnal back pain 26,27 Based on the BASDAI question 'How would you describe the overall level of AS neck, back 26 Pain relief was maintained through 4 years in both the anti-TNF-naïve and anti-TNF-IR populations. 42 Back pain in AS typically improves with exercise and is worse at night, so nocturnal back pain is commonly recorded in clinical trials. As has been noted, fatigue is a critical symptom for patients with AS and its impact on patient QoL can be further compounded by nocturnal back pain.…”

“…Morning stiffness is one of the core domains that ASAS/ OMERACT identify as being important to evaluate in patients with AS, 24 and there are data demonstrating a beneficial effect of secukinumab on this important aspect of disease. 42 In an exploratory analysis using observed data from MEASURE 2, improvements in overall morning stiffness (assessed using an average of questions 5 and 6 on the BASDAI) were seen at 42 Improvements with secukinumab were sustained at 4 years (−3.32 unit change from baseline; clinically meaningful improvement reported in 77.2% of patients). 42 Improvements in morning stiffness were greater than placebo regardless of previous exposure to anti-TNF therapy, although the magnitude of improvement was higher in anti-TNF-naïve patients.…”

“…42 In an exploratory analysis using observed data from MEASURE 2, improvements in overall morning stiffness (assessed using an average of questions 5 and 6 on the BASDAI) were seen at 42 Improvements with secukinumab were sustained at 4 years (−3.32 unit change from baseline; clinically meaningful improvement reported in 77.2% of patients). 42 Improvements in morning stiffness were greater than placebo regardless of previous exposure to anti-TNF therapy, although the magnitude of improvement was higher in anti-TNF-naïve patients. 42 At Week 16, a −3.03 unit change from baseline was observed in secukinumab-treated anti-TNFnaïve patients versus −1.15 with placebo, while in anti-TNF-IR patients, changes from baseline were −1.44 and −0.31, respectively.…”

“…26 Pain relief was maintained through 4 years in both the anti-TNF-naïve and anti-TNF-IR populations. 42 …”