POS0937 MEASURE 2: SECUKINUMAB PROVIDES RAPID AND SUSTAINED RELIEF FROM KEY CLINICAL SYMPTOMS OF ACTIVE ANKYLOSING SPONDYLITIS IN TNFi-NAÏVE PATIENTS THROUGH 5 YEARS

Abstract

BackgroundAnkylosing spondylitis (AS) is a chronic, inflammatory disease resulting in debilitating clinical symptoms such as pain (70–83%), stiffness (54–90%) and fatigue (53–62%).1-3 Secukinumab (SEC 150 mg) has demonstrated long-term efficacy across multiple indications and is approved for the treatment of active AS in adults who have had an inadequate response to NSAIDs.4,5ObjectivesThe Phase 3 MEASURE 2 trial (NCT01649375) assessed long-term efficacy, safety and tolerability of SEC in patients (pts) with active AS. This post-hoc analysis was conducted specifically to evaluate long-term efficacy of SEC 150 mg on key clinical symptoms of pain, morning stiffness, physical function and fatigue in TNFi-naïve pts over 5 years.MethodsThe MEASURE 2 study design has been reported previously.5 This post-hoc analysis evaluated key clinical symptoms at baseline through Wk 260. Assessments included total and nocturnal back pain (visual analogue scale [0–100 mm]), overall spinal pain (neck, back, or hip) from BASDAI, and morning stiffness (average BASDAI). Physical function (SF-36 PCS, BASFI), fatigue (BASDAI, FACIT) and disease activity (ASDAS-CRP) are also reported. Data are presented as LS mean change (± SE) using mixed model repeated measures from Wks 4–16 and observed data (mean ± SD) from Wks 24–260.ResultsOf TNFi-naïve pts randomised to SEC 150 mg, 89 were included (SEC, n=44, placebo [PBO], n=45) in this analysis. Of these pts randomised to SEC 150 mg, 84% completed 5 years of treatment. Significantly greater improvements were observed in pts treated with SEC 150 mg vs PBO at Wk 16 and were sustained through 5 years (Figure 1; Table 1).Table 1.Pain, physical function and fatigue scoresEndpointTreatmentBL mean ± SD*Wk 16 LS mean, SE (p-value)Wk 52 ± SDWk 104 ± SDWk 156 ± SDWk 208 ± SDWk 260 ± SDBACK PAINTotal back painSEC66.86 ± 15.42-33.99, 3.42 (p=0.0000)-40.56 ± 24.35-37.74 ± 26.09-39.03 ± 26.65-37.77 ± 28.40-36.78 ± 29.76PBO67.69 ± 17.71-12.75, 3.46NANANANANANocturnal back painSEC66.84 ± 14.17-36.25, 3.50 (p=0.0000)-45.13 ± 23.92-40.54 ± 25.23-43.92 ± 25.10-41.13 ± 24.87-38.95 ± 28.91PBO63.87 ± 18.78-14.41, 3.54NANANANANAPHYSICAL FUNCTIONSF-36 PCSSEC34.87 ± 6.587.90, 0.98 (p=0.0012)8.44 ± 7.488.95 ± 7.878.98 ± 8.179.39 ± 8.398.55 ± 9.32PBO35.45 ± 6.513.23, 0.98NANANANANABASFISEC6.42 ± 1.95-2.89, 0.31 (p=0.0002)-3.38 ± 2.38-3.23 ± 2.39-3.10 ± 2.49-3.10 ± 2.47-2.86 ± 2.61PBO6.34 ± 1.99-1.18, 0.32NANANANANAFATIGUEOverall level (BASDAI)SEC7.00 ± 1.26-2.39, 0.34 (p=0.0095)-3.44 ± 2.32-3.30 ± 2.45-3.16 ± 2.61-3.12 ± 2.34-2.92 ± 2.71PBO7.18 ± 1.49-1.12, 0.34NANANANANAFACITSEC22.27 ± 8.0210.62, 1.26 (p=0.0052)12.14 ± 9.7611.00 ± 9.3710.79 ± 8.9112.39 ± 9.0910.64 ± 10.66PBO23.22 ± 7.945.48, 1.26NANANANANADISEASE ACTIVITYASDAS-CRPSEC3.73 ± 0.82-1.47, 0.14 (p=0.0000)-1.80 ± 1.16-1.66 ± 1.21-1.63 ± 1.35-1.69 ± 1.24-1.58 ± 1.36PBO3.89 ± 0.76-0.51, 0.14NANANANANA*Baseline refers to mean ± SD of observed values. LS mean change using MMRM for Wk 16 and observed data (mean ± SD) from Wks 24–260. SEC 150 mg, N=44 and PBO, N=45. ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score - C-reactive protein; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BL, baseline; FACIT, Functional Assessment of Chronic Illness Therapy; LS, least square; MMRM, mixed-effects model repeated measures; NA, not available; PBO, placebo; SD, standard deviation; SEC, secukinumab; SF-36 PCS, Short Form-36 Physical Component Summary; Wk, week.ConclusionTNFi-naïve pts with active AS treated with SEC 150 mg experienced rapid improvements across a range of key clinical symptoms including pain, physical function and fatigue measures, that were sustained through 5 years.References[1]Deodhar A et al. 2020 BMC Rheumatol 2020;4:19[2]Ward M et al. Arth Care Res 1999;12:247–55[3]van Tubergen A et al. Arth Rheum 2002;47:8–16[4]Cosentyx SmPC (2020) [Accessed: 24 Jan 22][5]Baeten D et al. N Eng J Med 2015;373:2534–48AcknowledgementsThis study was sponsored by Novartis Pharma. Medical writing support for the development of this abstract, under the direction of the authors, was provided by Laura Crocker (BMedSci, Hons) of Ashfield MedComms, an Ashfield Health company, and funded by Novartis PharmaDisclosure of InterestsKarel Pavelka Speakers bureau: AbbVie, Pfizer, Roche, Eli Lilly, BMS, MSD, USB, Alan Kivitz Shareholder of: Amgen, Novartis, Gilead, Pfizer, Glaxosmithkline, Sanofi, Speakers bureau: AbbVie, Merck, Celgene, Novartis, Flexion, Pfizer, Gilead, Sanofi, UCB, Horizon, Consultant of: AbbVie, Celgene, Janssen, Boehringer Ingelheim, Pfizer, Flexion, Regeneron, Gilead, Sanofi, Sun Pharma Advanced Research, UCB, Merck, Novartis, Horizon, Renato Calheiros Employee of: I am currently an employee for Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, Erhard Quebe-Fehling Shareholder of: Novartis, Employee of: Novartis, Patricia Pertel Shareholder of: Novartis, Employee of: Novartis, Ricardo Blanco Speakers bureau: AbbVie, Amgen, Bristol-Myers, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and Sanofi, Consultant of: Astra-Zeneca, Galapagos, Janssen, Novartis, Pfizer, Grant/research support from: AbbVie, and Roche