scholarly journals OP0053 SECUKINUMAB IMPROVES CLINICAL AND IMAGING OUTCOMES IN PATIENTS WITH PSORIATIC ARTHRITIS AND AXIAL MANIFESTATIONS WITH INADEQUATE RESPONSE TO NSAIDS: WEEK 52 RESULTS FROM THE MAXIMISE TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 35-36 ◽  
Author(s):  
X. Baraliakos ◽  
L. Gossec ◽  
E. Pournara ◽  
S. Jeka ◽  
R. Blanco ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Controlled Trial ◽  
Spinal Pain ◽  
Inadequate Response ◽  
Imaging Data ◽  
Sacroiliac Joints ◽  
Research Support ◽  
Double Blind ◽  
Randomised Controlled ◽  
Mri Score

Background:Although axial disease may affect up to 70% of patients (pts) with Psoriatic Arthritis (PsA), evidence on the efficacy of biologics in the treatment of axial manifestations in such pts is limited,1particularly as validated classification criteria for this subtype of PsA are not yet available. MAXIMISE (NCT02721966) is the first randomised controlled trial evaluating the efficacy of a biologic in the management of the axial manifestations of PsA and showed that secukinumab (SEC) 300 and 150 mg provided rapid and significant improvement in ASAS20 responses in these pts through week (Wk) 12.2Objectives:To present 52 wks efficacy results and imaging data from the MAXIMISE trial.Methods:This phase 3b, double-blind, placebo (PBO)-controlled, multicentre 52-wk trial included 498 pts (aged ≥18 years) with a diagnosis of PsA and classified by CASPAR criteria, spinal pain VAS score ≥ 40/100 and BASDAI score ≥ 4 despite use of at least two NSAIDs. Pts were randomised to SEC 300 mg (N=167) or SEC 150 mg (N=165) or PBO (N=166) wkly for 4 wks and every 4 wks thereafter. At Wk 12, PBO pts were re-randomised to SEC 300/150 mg. The primary endpoint was ASAS20 response with SEC 300 mg at Wk 12. The key secondary endpoint was ASAS20 response with SEC 150 mg at Wk 12. Wk 52 data are presented as observed. Bone marrow oedema of the entire spine and sacroiliac joints were assessed centrally with Berlin MRI scores at Baseline, Wk 12 and Wk 52.Results:Primary and key secondary endpoints were met; ASAS20 responses were sustained and increased further through Wk 52. 75%/79.7% of the PBO pts re-randomised at Wk 12 to SEC 300/150 mg achieved ASAS20 response at Wk 52 (Figure 1). ASAS40 responses at Wk 52 were 69.1% [SEC 300 mg], 64.5% [SEC 150 mg], 62.5% [PBO-SEC 300 mg], and 54.1% [PBO-SEC 150 mg]. At baseline, 59.5% [SEC 300 mg], 53.5% [SEC 150 mg] and 64.2% [PBO] of the pts had positive MRIs for the sacroiliac joints and/or the spine with Berlin MRI score ≥1. The reductions of Berlin MRI score for entire spine and sacroiliac joints were statistically significant for pts treated with SEC 300/150 mg vs. placebo (Figure 2a and b). There were no new or unexpected safety findings.Figure 1.ASAS20 Response over 52 Wks*Figure 2.Total Berlin MRI score for the Entire Spine and Sacroiliac Joints at Wk 12Conclusion:Secukinumab improved all evaluated ASAS responses through Wk 52 in PsA pts with axial manifestations and inadequate responses to NSAIDs and led to significant reduction of inflammatory MRI lesions in the spine and the Sacroiliac Joints. The safety profile of secukinumab through Wk 52 was consistent with previous reports.3-4References:[1]McInnes IB, et al.Lancet.2015;386(9999):1137–46.[2]Baraliakos X, et al.Arthritis Rheumatol. 2019;71 (suppl 10).[3]Langley RG, et al.N Engl J Med.2014;371:326–38.[4]Sieper J, et al.Ann Rheum Dis.2016;0:1–8.Acknowledgments:The study was sponsored by Novartis Pharma AG, Basel, Switzerland.Disclosure of Interests:Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB, Effie Pournara Shareholder of: Novartis, Employee of: Novartis, Sławomir Jeka Grant/research support from: AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Eli Lilly, Egis, UCB, Celgene, Speakers bureau: AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Eli Lilly, Egis, UCB, Celgene, Ricardo Blanco Grant/research support from: AbbVie, MSD, Roche, Consultant of: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Speakers bureau: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma. MSD, Salvatore D’Angelo Consultant of: AbbVie, Biogen, BMS, Celgene, Eli Lilly, MSD, Novartis, and UCB, Speakers bureau: AbbVie, BMS, Celgene, Eli Lilly, Novartis, Pfizer, and Sanofi, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB, Barbara Schulz Employee of: Novartis, Michael Rissler Shareholder of: Novartis, Employee of: Novartis, Kriti Nagar Employee of: Novartis, Chiara Perella Shareholder of: Novartis, Employee of: Novartis, Laura C Coates: None declared

scholarly journals P184 Secukinumab provides sustained improvements in clinical and imaging outcomes in patients with psoriatic arthritis and axial manifestations: results from the MAXIMISE trial

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Xenofon Baraliakos ◽  
Laure Gossec ◽  
Effie Pournara ◽  
Slawomir Jeka ◽  
Ricardo Blanco ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Psoriatic Arthritis ◽  
Magnetic Resonance ◽  
Spinal Pain ◽  
Stock Ownership ◽  
Resonance Imaging ◽  
Sacroiliac Joints ◽  
Research Support ◽  
Number Of Patients ◽  
Mri Score

Abstract Background/Aims  MAXIMISE, the first randomised controlled trial evaluating efficacy of a biologic for psoriatic arthritis (PsA) axial manifestations, showed that secukinumab 300 and 150 mg provided rapid and significant improvement in ASAS20 responses through Week 12. We report the effect of secukinumab on clinical and imaging outcomes through 52 weeks. Methods  This Phase 3, double-blind, multicentre trial included 498 patients (≥18 years) with PsA who fulfilled CASPAR criteria presenting with spinal pain VAS ≥40/100, BASDAI ≥4 and inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs. Patients were randomised to secukinumab 300 mg (N = 167), 150 mg (N = 165) or placebo (N = 166) weekly for 4 weeks and every 4 weeks thereafter. At Week 12, placebo patients were re-randomised to secukinumab 300/150 mg. The primary endpoint was ASAS20 with secukinumab 300 mg at Week 12. Exploratory assessments at Week 52 included ASAS20/40, BASDAI50, spinal pain (VAS) and improvement in Berlin magnetic resonance imaging (MRI) score for spine and sacroiliac joints. Results  The primary endpoint was met. ASAS20/40 responses at Week 12 were 62.9%/43.6% (secukinumab 300 mg) and 66.3%/39.5% (secukinumab 150 mg) versus 31.2%/12.2% (placebo), respectively (P < 0.0001). ASAS20/40 responses improved further with secukinumab 300/150 mg from baseline through 52 weeks. 74.1%/74.7% and 63.0%/50.6% of placebo patients, re-randomised at Week 12 to secukinumab 300/150 mg, achieved ASAS20/40 at Week 52. At baseline, 59.5% (secukinumab 300 mg), 54.2% (secukinumab 150 mg) and 64.2% (placebo) of patients had positive MRI scores for the sacroiliac joints and/or the spine. Reductions in Berlin MRI scores for the entire spine and sacroiliac joints were sustained with secukinumab 300/150 mg from baseline through 52 weeks (Table 1). 64.6%, 69.1% and 33.6% of patients with inflammatory back pain at baseline, confirmed by ASAS, Calin et al. and Berlin criteria in the secukinumab 300 mg, 150 mg and placebo groups, respectively, achieved ASAS20 at Week 12. P184 Table 1:Endpoints at Week 52CriteriaSecukinumab 300 mg SC (N = 164)Secukinumab 150 mg SC (N = 157)Placebo to secukinumab 300 mg SC (N = 81)Placebo to secukinumab 150 mg SC (N = 80)Clinical endpointsASAS20, % responders (n/M)a75.5 (123/163)77.3 (119/154)74.1 (60/81)74.7 (59/79)ASAS40, % responders (n/M)a62.6 (102/163)60.4 (93/154)63.0 (51/81)50.6 (40/79)BASDAI50, % responders (n/M)b68.3 (95/139)58.5 (83/142)55.6 (40/72)54.1 (40/74)Spinal pain VAS, mean change from BL (SD), nb-42.4 (27.0), 140-43.8 (26.2), 142-43.1 (25.0), 72-36.4 (25.2), 74Imaging endpointBerlin MRI score for entire spine, mean change from BL (SD), nb-0.6 (2.3), 121-0.3 (1.3), 124-0.8 (2.7), 63-0.4 (1.3), 60Berlin MRI score for SIJ, mean change from BL (SD), nb-0.7 (2.2), 122-0.5 (1.7), 122-0.9 (2.4), 63-1.0 (2.7), 59N=total number of patients in the group; n=number of patients with response; M=number of evaluable patients. aIntermediate missing data as well as any data missing in the case of study discontinuation is imputed using LOCF; bObserved data. Patients with initial placebo treatment were re-randomised to secukinumab 300 or 150 mg at Week 12. ASAS, Assessment of SpondyloArthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BL, baseline; LOCF, last observation carried forward; MRI, magnetic resonance imaging; SC, subcutaneous; SD, standard deviation; SIJ, sacroiliac joints; VAS, visual analogue scale. Conclusion  Secukinumab improved signs and symptoms of axial disease (ASAS20/40) through 52 weeks with reduced inflammatory MRI lesions in the spine and sacroiliac joints in PsA patients with axial manifestations. Efficacy at Week 52 was comparable in patients who switched at Week 12 from placebo to secukinumab 300/150 mg. Disclosure  X. Baraliakos: Consultancies; AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen. Member of speakers’ bureau; AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Novartis. L. Gossec: Consultancies; AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB. Grants/research support; Lilly, Mylan, Pfizer, Sandoz. E. Pournara: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. S. Jeka: Grants/research support; AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Lilly, Egis, UCB, Celgene. R. Blanco: Consultancies; AbbVie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma, MSD. Grants/research support; AbbVie, MSD, Roche. S. D'Angelo: Consultancies; AbbVie, Biogen, BMS, Celgene, Lilly, MSD, Novartis, UCB. Member of speakers’ bureau; AbbVie, BMS, Celgene, Lilly, Novartis, Pfizer, Sanofi. G. Schett: Honoraria; AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Roche, UCB. B. Schulz: Corporate appointments; Employee of Novartis. M. Rissler: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. D. Whyms: Corporate appointments; Employee of Novartis. C. Perella: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. L.C. Coates: Consultancies; : AbbVie, Amgen, Biogen, Celgene, Pfizer, UCB, Boehringer Ingelheim, Novartis, Lilly, Janssen, Sun Pharma, Prothena, Gilead. Grants/research support; AbbVie, Janssen, Lilly, Novartis, Pfizer, Amgen.

scholarly journals P284 Certolizumab pegol-treated patients with non-radiographic axSpA demonstrate improvements in sleep quality and other patient reported outcomes

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Raj Sengupta ◽  
Lianne Gensler ◽  
Jonathan Kay ◽  
Walter Maksymowych ◽  
Nigil Haroon ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Patient Reported Outcomes ◽  
Sleep Problems ◽  
Certolizumab Pegol ◽  
Spinal Pain ◽  
Controlled Study ◽  
Inadequate Response ◽  
Research Support ◽  
Double Blind ◽  
Patient Reported

Abstract Background Certolizumab pegol (CZP) treatment has demonstrated improvements in multiple manifestations of non-radiographic axial spondyloarthritis (nr-axSpA), including patient-reported outcomes (PROs). Here, we report PROs for nr-axSpA patients treated with CZP or placebo in CaxSpAnd - the first 52-week placebo-controlled study to investigate the efficacy of an anti-TNF agent in patients with active nr-axSpA and objective signs of inflammation. Methods C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicenter study including a 52-week double-blind, placebo-controlled period (completed); patients who had an inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs were randomized 1:1 to placebo or CZP (400mg at Weeks 0/2/4, then 200mg every 2 weeks). Clinical PROs included: Sleep Problems Index scores I (6 items) and II (9 items) from the Medical Outcomes Study Sleep Scale (assesses sleep disturbance, adequacy, somnolence, quantity, snoring, and awakening short of breath or with a headache), nocturnal spinal pain (numerical rating scale [NRS]), fatigue (BASDAI Q1), and morning stiffness (average of BASDAI Q5 + 6). Post-hoc analyses of minimal clinically important differences (MCID [≥1-point improvement]) for fatigue and nocturnal spinal pain were conducted. Variables were analyzed using an ANCOVA model including baseline score as a covariate and fixed effects for treatment group, region and MRI/CRP classification. P-values were nominal. Missing values following discontinuation of double-blind treatment were imputed using last observation carried forward. Results 317 patients with nr-axSpA were randomised to CZP (n = 159) or placebo (n = 158); 125 (79%) and 54 (34%) patients, respectively, completed Week 52. CZP-treated patients showed greater improvements (indicated by higher scores) in Sleep Problems Index II scores vs placebo-treated patients at Week 12 (mean change from baseline: 4.8 [CZP] vs 2.2 [placebo]; p < 0.001). Improvements were also seen in other clinical PROs (Table). By Week 12, greater proportions of patients treated with CZP vs placebo experienced at least MCID response in fatigue (85.4% vs 57.6%, respectively) and nocturnal spinal pain (82.8% vs 58.9%, respectively); results were sustained through Week 52. Conclusion CZP-treated nr-axSpA patients showed substantial improvements in sleep quality and other clinical outcomes important to patients; future analyses of these data will explore associations between sleep quality and other clinical PROs. Disclosures R. Sengupta: Other; R.S. has received speaker fees, support for conference attendance and grants from Abbvie, Biogen, Celgene, Novartis, Pfizer and UCB Pharma. L. Gensler: Grants/research support; AbbVie, Amgen, Novartis, UCB Pharma; consulting fees from Galapagos, Eli Lilly and Janssen. J. Kay: Consultancies; AbbVie, Boehringer Ingelheim, Celltrion Healthcare, Horizon Therapeutics, Merck Sharp & Dohme, MorphoSys, Novartis, Pfizer, Samsung Bioepis, Sandoz and UCB Pharma. Grants/research support; Gilead Sciences, Novartis AG, Pfizer and UCB Pharma. W. Maksymowych: Other; Consultant and/or speaker fees and/or grants from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma. N. Haroon: Consultancies; Abbvie, Amgen, Eli Lilly, Janssen, Novartis and UCB Pharma. L. Bauer: Other; Employee of UCB Pharma. B. Hoepken: Other; Employee of UCB Pharma. N. de Peyrecave: Other; Employee of UCB Pharma. T. Kumke: Other; Employee of UCB Pharma. A. Deodhar: Consultancies; AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer and UCB. Grants/research support; BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer and UCB.

scholarly journals LB0001 EFFICACY AND SAFETY OF UPADACITINIB VERSUS PLACEBO AND ADALIMUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND INADEQUATE RESPONSE TO NON-BIOLOGIC DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS (SELECT-PsA-1): A DOUBLE-BLIND, RANDOMIZED CONTROLLED PHASE 3 TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 16.2-17
Author(s):  
I. Mcinnes ◽  
J. Anderson ◽  
M. Magrey ◽  
J. F. Merola ◽  
Y. Liu ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Study Drug ◽  
Musculoskeletal Symptoms ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Research Support ◽  
Self Assessment ◽  
Double Blind ◽  
Biologic Dmard ◽  
Secondary Endpoints

Background:Upadacitinib (UPA) is an oral, reversible, JAK inhibitor approved for treatment of rheumatoid arthritis (RA) and currently under evaluation for treatment of psoriatic arthritis (PsA).Objectives:To assess the efficacy and safety of UPA vs placebo (PBO) and adalimumab (ADA) in patients (pts) with PsA and prior IR or intolerance to ≥1 non-biologic DMARD (non-bDMARD).Methods:Pts with active PsA (≥3 swollen and ≥3 tender joints), active or historical psoriasis, and on ≤2 non-bDMARDs were randomized 1:1:1:1 to once daily UPA 15 mg (UPA15), UPA 30 mg (UPA30), ADA 40 mg every other week, or PBO. The primary endpoint was the proportion of pts achieving ACR20 for UPA vs PBO at Wk 12. Multiplicity controlled secondary endpoints for each dose of UPA vs PBO included change in HAQ-DI, FACIT-F, and SF-36 PCS (Wk 12); static Investigator Global Assessment of Psoriasis of 0 or 1, PASI75, and change in Self-Assessment of Psoriasis Symptoms (Wk 16); change in modified Sharp/van der Heijde Score (mTSS), proportion of pts achieving MDA, and resolution of enthesitis (LEI=0) and dactylitis (LDI=0) (Wk 24). For each dose of UPA, the multiplicity-controlled analysis also included non-inferiority and superiority vs ADA for ACR20 and superiority for HAQ-DI and pt’s assessment of pain NRS (Wk 12). ACR50/70 at Wk 12 and ACR20 at Wk 2 were additional secondary endpoints. Treatment-emergent adverse events (TEAEs) through 24 wks are reported for pts who received ≥1 dose of study drug.Results:1705 pts were randomized; 1704 received study drug (53.2% female, mean age 50.8 yrs, mean duration of PsA diagnosis 6.1 yrs). 82% were on ≥1 concomitant non-bDMARD, of whom 84% received MTX +/- another non-bDMARD.At Wk 12, ACR20 rates were 70.6% with UPA15 and 78.5% with UPA30 vs 36.2% with PBO (p < .001 for UPA15/30 vs PBO) and 65.0% with ADA (non-inferiority, p < .001 for UPA15/30 vs ADA; superiority, p < .001 for UPA30 vs ADA). A greater proportion of pts achieved ACR50/70 with UPA15/30 vs PBO and UPA30 vs ADA. Improvements were observed with UPA15/30 vs PBO for all multiplicity controlled secondary endpoints and for UPA 15/30 vs ADA for HAQ-DI and UPA 30 vs ADA for improvement in pain (Figure 1A-1B). At Wk 24, change in mTSS was 0.25 for PBO, -0.04 for UPA15, 0.03 for UPA30, and 0.01 for ADA (p < 0.001 for UPA15/30 vs PBO). The rates of TEAEs and serious AEs, including serious infections, were similar in the PBO, UPA15, and ADA arms and higher with UPA30 (Figure 2). The rate of herpes zoster was similar for PBO and UPA15/30. No MACE was reported with UPA. One malignancy occurred in each of the PBO and UPA15 arms, and 3 malignancies were reported in each of the UPA30 and ADA arms. VTE were reported in 1 pt on PBO, 1 pt on UPA30, and 2 pts on ADA. One death occurred in the PBO arm.Conclusion:In this non-bDMARD-IR PsA population, treatment with UPA15/30 demonstrated improvement in musculoskeletal symptoms, psoriasis, physical function, pain, and fatigue and inhibited radiographic progression; improvements were observed by Wk 2. At Wk 12, UPA15/30 were non-inferior to ADA for ACR20, with superiority demonstrated for UPA30. Greater percentages of UPA vs PBO pts achieved stringent measures of disease control (MDA, ACR50/70, sIGA 0/1). No new safety signals were identified compared with the safety profile observed in RA.Disclosure of Interests:Iain McInnes: None declared, Jaclyn Anderson Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Marina Magrey Grant/research support from: Amgen, AbbVie, and UCB Pharma, Consultant of: Novartis, Eli Lilly, Pfizer, and Janssen, Joseph F. Merola Consultant of: Merck, Abbvie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and Leo Pharma, Yi Liu: None declared, Mitsumasa Kishimoto Consultant of: bbVie, Eli Lilly, Celgene, Pfizer, Gilead, Janssen, and UCB Pharma, Speakers bureau: AbbVie, Eisai, Celgene, Pfizer, Novartis, Eli Lilly, Tanabe-Mitsubishi, Ayumi, Janssen, Astellas, and UCB Pharma, Sławomir Jeka Speakers bureau: AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Eli Lilly, Egis, UCB, Celgene, Cesar Francisco Pacheco Tena: None declared, xin wang Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Liang Chen Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Patrick Zueger Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Aileen Pangan Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Frank Behrens Grant/research support from: Pfizer, Janssen, Chugai, Celgene and Roche, Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, UCB, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai

scholarly journals Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial

2020 ◽  
pp. annrheumdis-2020-218808
Author(s):  
Xenofon Baraliakos ◽  
Laure Gossec ◽  
Effie Pournara ◽  
Slawomir Jeka ◽  
Antonio Mera-Varela ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Visual Analogue Score ◽  
Spinal Pain ◽  
Inadequate Response ◽  
Double Blind ◽  
Registration Number ◽  
Axial Disease

ObjectivesMAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA).MethodsThis phase 3b, double-blind, placebo-controlled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12.ResultsPatients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p<0.0001).ConclusionsSecukinumab 300 mg and 150 mg provided significant improvement in signs and symptoms of axial disease compared with placebo in patients with PsA and axial manifestations with inadequate response to NSAIDs.Trial registration numberNCT02721966.

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