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.

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P250 Effect of secukinumab on radiographic progression through 2 years in patients with active PsA: end-of-study results from a Phase 3 study

Rheumatology ◽

10.1093/rheumatology/keaa111.243 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Hasan Tahir ◽

Philip Mease ◽

Robert Landewé ◽

Proton Rahman ◽

Atul Singhal ◽

...

Keyword(s):

Radiographic Progression ◽

Stock Ownership ◽

Inadequate Response ◽

Tnf Inhibitor ◽

Research Support ◽

Random Intercept ◽

Study Results ◽

Clinical Responses ◽

Pharmaceutical Industries ◽

Random Slopes

Abstract Background Secukinumab demonstrated sustained efficacy, inhibition of radiographic progression and a stable safety profile over 52 weeks in patients with psoriatic arthritis (PsA) in FUTURE 5. We report the end-of-study (2-year) results on the effect of secukinumab on radiographic progression in PsA patients in FUTURE 5. Methods Adults (N = 996) with active PsA were randomised to subcutaneous secukinumab 300 mg load, 150 mg load, 150 mg no load or placebo at baseline, Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. The secukinumab dose could be escalated from 150 to 300 mg from Week 52 onwards, based on physician judgement. Radiographic progression (mean change in vdH-mTSS) was based on hand/wrist/foot radiographs obtained at baseline, and Weeks 16 (nonresponders), 24, 52 and 104, assessed by two blinded readers (plus an adjudicator if required). Radiographic data were analysed using a linear mixed-effects model (random intercept, random slopes) at Weeks 24 and 52, and as observed at Week 104. Data are presented for patients originally randomised to secukinumab (300 and 150 mg); the 150 mg groups also included patients who had dose escalation to 300 mg. Analyses by prior TNF inhibitor (TNFi) status (naive vs inadequate response) were also performed. Results Overall, 85% (300 mg), 82% (150 mg) and 75% (150 mg no load) of patients completed 2 years of treatment. A total of 86 (39%) and 92 (41%) patients had their dose escalated to 300 mg in the 150 mg and 150 mg no load groups, respectively. In the overall population, the proportions of patients with no radiographic progression (change from baseline in vdH-mTSS≤0.5) with secukinumab were 89.5% (300 mg), 82.3% (150 mg) and 81.1% (150 mg no load) at 2 years; the corresponding proportions of patients with changes from baseline in vdH-mTSS≤0.0 were: 81.2%, 69.1% and 73.4%, respectively. Radiographic progression was low in secukinumab-treated patients in the overall population and by prior TNFi use over 2 years (Table 1). Clinical responses were sustained through 2 years of secukinumab treatment. Conclusion Low radiographic progression was observed over 2 years of treatment with secukinumab 300 and 150 mg in PsA patients. Disclosures H. Tahir: Member of speakers’ bureau; AbbVie, Janssen, Eli Lilly, Novartis. Grants/research support; Novartis, Eli Lilly. P. Mease: Consultancies; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, INC pharma, UCB, Crescendo Bioscience. Member of speakers’ bureau; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer, UCB, Crescendo Bioscience. Grants/research support; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, INC pharma, UCB, Crescendo Bioscience. R. Landewé: None. P. Rahman: Consultancies; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, UCB. Member of speakers’ bureau; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis. Grants/research support; Janssen, Novartis. A. Singhal: Grants/research support; AbbVie, Gilead, Sanofi, Regeneron, Amgen, Roche, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Pfizer, UCB, Astra Zeneca, MedImmune, FujiFilm, Nichi-Iko, Mallinckrodt. E. Böttcher: Consultancies; Amgen, Roche, Eli Lilly, Pfizer, MSD, Novartis. Member of speakers’ bureau; Amgen, Roche, Eli Lilly, Pfizer, MSD, Novartis. S. Navarra: Member of speakers’ bureau; Astellas, Johnson & Johnson, Novartis, Pfizer. A. Readie: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. S. Mpofu: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. E. Delicha: Consultancies; Novartis. L. Pricop: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. D. van der Heijde: Corporate appointments; Imaging Rheumatology BV. Consultancies; AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma.

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AB0827 IMPACT OF BASELINE BODY MASS INDEX ON THE EFFICACY AND SAFETY OF TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.993 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1717.2-1718

Author(s):

C. T. Ritchlin ◽

A. Ogdie ◽

J. T. Giles ◽

J. J. Gomez-Reino ◽

P. Helliwell ◽

...

Keyword(s):

Body Mass Index ◽

Body Mass ◽

Janus Kinase ◽

Inadequate Response ◽

Tnf Inhibitor ◽

Efficacy And Safety ◽

Lipid Levels ◽

Research Support ◽

Link Type ◽

Advanced Therapies

Background:Obesity is highly prevalent in PsA (~45%)1and is associated with a reduced response to TNF inhibitors.2Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA.Objectives:This post hoc analysis assessed tofacitinib efficacy and safety in patients (pts) with PsA by baseline (BL) body mass index (BMI) category.Methods:Data were pooled from two placebo (PBO)-controlled, double-blind, Phase 3 studies in pts with active PsA and an inadequate response to ≥1 conventional synthetic DMARD (OPAL Broaden [12 months;NCT01877668]) or to ≥1 TNF inhibitor (OPAL Beyond [6 months;NCT01882439]).3,4This analysis included pts randomised to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID or PBO, stratified by BL BMI: <25 kg/m2, ≥25–<30 kg/m2, ≥30–<35 kg/m2, or ≥35 kg/m2. Efficacy and safety were reported to Month (M)3. M3 efficacy outcomes included ACR20/50/70 and HAQ-DI responses, dactylitis and enthesitis resolution rates and changes from BL in HAQ-DI, Short Form-36 Version 2 (SF-36v2) Physical (PCS) and Mental Component Summary (MCS) scores, and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores. Safety outcomes included adverse events (AEs), such as cardiovascular (CV) events and changes in lipid levels and liver function tests (LFTs).Results:This analysis included 710 pts; 43.8% were obese (BMI ≥30). At BL, 161 (22.7%) pts had a BMI <25, 238 (33.5%) had a BMI ≥25–<30, 186 (26.2%) had a BMI ≥30–<35 and 125 (17.6%) had a BMI ≥35. Most pts were white (92.5–96.8%), middle-aged (mean: 44.5–51.2 yrs) and female (49.5–65.6%). Greater proportions of obese pts were from Russia/Eastern Europe (35.0%) and USA/Canada (31.8%), vs the rest of world. At BL, higher BMI correlated with an increased prevalence of metabolic syndrome (4.3% in BMI <25 to 76.0% in BMI ≥35) and CRP levels >2.87 mg/L (49.1% in BMI <25 to 84.0% in BMI ≥35). Higher proportions of pts (42.5–47.9%) in BL BMI categories <35 reported no prior biologic DMARD use, vs pts with a BL BMI ≥35 (33.6%). At M3, efficacy improvements were greater in tofacitinib-treated pts vs PBO-treated pts (Figure 1). In pts with a BL BMI ≥35, a trend towards fewer pts responding was observed (Figure 1) and mean changes from baseline in SF-36v2 PCS and MCS and FACIT-F generally appeared lower (Figure 2) vs pts in lower BL BMI categories. Up to M3, the proportions of pts with AEs, and percentage change from BL in lipid levels and LFTs, were generally similar across all BL BMI categories. Three CV events were reported: non-fatal cerebrovascular accident, transient ischemic attack (both tofacitinib 5 mg BID, BMI ≥30–<35) and coronary artery revascularisation (PBO; BMI ≥35). Limitations include the 3-month observation time, particularly for safety findings, thus longer observation times are warranted.Conclusion:Regardless of BL BMI, tofacitinib demonstrated greater efficacy than PBO at M3 in pts with PsA. Similar to other advanced therapies,2reduced efficacy was generally observed in tofacitinib and PBO pts with a BL BMI ≥35. Tofacitinib safety appeared consistent across all BL BMI categories.References:[1]Labitigan et al. Arthritis Care Res (Hoboken) 2014;66:600-07.[2]Singh et al. PLoS One 2018;13:e0195123.[3]Mease et al. NEJM 2017;377:1537-50.[4]Gladman et al. NEJM 2017;377:1525-36.Acknowledgments:Medical writing support was provided by Mark Bennett of CMC Connect, McCann Health Medical Communications, and funded by Pfizer Inc.Disclosure of Interests:Christopher T. Ritchlin Grant/research support from: UCB Pharma, AbbVie, Amgen, Consultant of: UCB Pharma, Amgen, AbbVie, Lilly, Pfizer, Novartis, Gilead, Janssen, Alexis Ogdie Shareholder of: Amgen, Novartis, Pfizer Inc, Grant/research support from: Novartis, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer Inc, Jon T Giles Grant/research support from: Pfizer Inc, Juan Jesus Gomez-Reino Grant/research support from: AbbVie, Novartis, Pfizer Inc, Roche, UCB, Consultant of: Pfizer Inc, Speakers bureau: AbbVie, Bristol-Myers Squibb, Janssen, MSD, Pfizer Inc, Roche, UCB, Philip Helliwell: None declared, Lori Stockert Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Pamela Young Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Wael Joseph Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Rajiv Mundayat Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Daniela Graham Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, John Woolcott Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Ana Belen Romero Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

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P173 Efficacy and safety of upadacitinib versus placebo and adalimumab in patients with active PsA and inadequate response to non-biologic DMARDs (SELECT-PSA-1): a double-blind, randomised controlled phase III trial

Rheumatology ◽

10.1093/rheumatology/keab247.168 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Iain McInnes ◽

Jaclyn Anderson ◽

Marina Magrey ◽

Joseph F Merola ◽

Yi Liu ◽

...

Keyword(s):

Study Drug ◽

Control Measures ◽

Phase Iii ◽

Musculoskeletal Symptoms ◽

Stock Ownership ◽

Inadequate Response ◽

Efficacy And Safety ◽

Research Support ◽

Double Blind ◽

Secondary Endpoints

Abstract Background/Aims Upadacitinib (UPA) is a JAK inhibitor under evaluation for PsA treatment. We aimed to assess efficacy and safety of UPA vs placebo (PBO) and adalimumab (ADA) in patients with prior inadequate response (IR) or intolerance to ≥ 1 non-biologic DMARD. This research was previously presented at EULAR; published in Annals of Rheumatic Diseases. Methods Patients with active PsA (≥3 swollen, ≥3 tender joints), active/historical psoriasis, ≤2 non-bDMARDs were randomized 1:1:1:1 to once-daily UPA 15mg (UPA15), UPA 30mg (UPA30), ADA 40mg every other week, or PBO. Primary endpoint: proportion of patients achieving ACR20 for UPA vs PBO at Wk12. Secondary endpoints: change in HAQ-DI, FACIT-F, SF-36-PCS (Wk12), sIGA of Psoriasis 0/1, PASI75, change in Self-Assessment of Psoriasis Symptoms (Wk16), change in modified Sharp/van der Heijde Score (mTSS), proportion patients achieving MDA, resolution of enthesitis (LEI=0) and dactylitis (LDI=0) (Wk24), non-inferiority and superiority vs ADA for ACR20, superiority for HAQ-DI, patient assessment of pain NRS (Wk12). Additional secondary endpoints: ACR50/70 at Wk12 and ACR20 at Wk2. Treatment-emergent adverse events (TEAEs) through Wk24 reported for patients receiving ≥1 dose of study drug. Results 1,705 patients were randomised; 1,704 received study drug (mean age 50.8 yrs, mean duration of PsA diagnosis 6.1 yrs). 82% on ≥ 1 concomitant non-bDMARD. At Wk12, ACR20 rates were 70.6% with UPA15 and 78.5% with UPA30 vs 36.2% with PBO (p < 0.001 for UPA15/30 vs PBO) and 65.0% with ADA (non-inferiority, p < 0.001 for UPA15/30 vs ADA; superiority, p < 0.001 for UPA30 vs ADA). More patients achieved ACR50/70 with UPA15/30 vs PBO and UPA30 vs ADA. Improvements were observed with UPA15/30 vs PBO for all secondary endpoints and for UPA 15/30 vs ADA for HAQ-DI and UPA30 vs ADA for improvement in pain. At Wk24, 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). Rates of TEAEs and serious AEs, including serious infections, were similar in PBO, UPA15, and ADA arms and higher with UPA30. Herpes zoster rates were similar for PBO and UPA15/30. No MACE was reported with UPA. One malignancy occurred in both the PBO and UPA15 arms; 3 malignancies were reported in both UPA30 and ADA arms. VTE were reported in 1 PBO patient, 1 UPA30 patient and 2 ADA patients. One death occurred in the PBO arm. Conclusion In this non-bDMARD-IR PsA population UPA15/30 demonstrated improvement in musculoskeletal symptoms, psoriasis, physical function, pain, fatigue and inhibited radiographic progression; improvements observed by Wk2. At Wk12, UPA15/30 were non-inferior to ADA for ACR20, with superiority demonstrated for UPA30. Greater percentages of UPA vs PBO patients achieved stringent disease control measures (MDA, ACR50/70, sIGA 0/1). No new safety signals were identified compared to the safety profile observed in RA. Disclosure I. McInnes: Other; I.McI has received research grants and honoraria from Abbvie, BMS, Celgene, Novartis Lilly, Janssen, Pfizer, UCB. J. Anderson: Shareholder/stock ownership; J.A. may be a stock/ shareholder of AbbVie Inc. M. Magrey: Consultancies; M.M. has received consulting fees from Novartis, Eli Lilly, Pfizer, and Janssen. Grants/research support; M.M. has received grants/ research support from Amgen, AbbVie, and UCB Pharma. J.F. Merola: Consultancies; J.F.M. is a consultant for Merck, Abbvie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and Leo Pharma. Y. Liu: None. M. Kishimoto: Consultancies; M.K. has received consulting fees from AbbVie, Eli Lilly, Celgene, Pfizer, Gilead, Janssen, and UCB Pharma. Honoraria; M.K. has received honoraria/ speakers fees from AbbVie, Eisai, Celgene, Pfizer, Novartis, Eli Lilly, Tanabe-Mitsubishi, Ayumi, Janssen, Astellas, and UCB Pharma. S. Jeka: None. C. Pacheco-Tena: None. X. Wang: Shareholder/stock ownership; X.W. may be a shareholder of AbbVie Inc. L. Chen: Shareholder/stock ownership; L.C. may be a stock/shareholder of AbbVie Inc. P. Zueger: Shareholder/stock ownership; P.Z. may be a stock/shareholder of AbbVie Inc. A. Pangan: Shareholder/stock ownership; A.P. may be a stock/shareholder of AbbVie Inc. F. Behrens: Honoraria; F.B. has received honoraria and speakers fees from Pfizer, AbbVie, Sanofi, Lilly, Novartis, UCB, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai. Grants/research support; F.B. has received grants/ research support from Pfizer, Janssen, Chugai, Celgene and Roche.

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O23 Ixekizumab (IXE) vs. adalimumab (ADA) for the treatment of PSA: 52-week efficacy and safety outcomes

Rheumatology ◽

10.1093/rheumatology/keaa110.022 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Christopher J Edwards ◽

Andrew J Bradley ◽

Mani H Nassab ◽

Burkhard Möller ◽

Klaus P Machold ◽

...

Keyword(s):

Severe Psoriasis ◽

Tender Joint Count ◽

Stock Ownership ◽

Physician Global Assessment ◽

Inadequate Response ◽

Full Time ◽

Research Support ◽

Open Label ◽

Tender Joint ◽

Full Time Employee

Abstract Background With multiple biologic disease-modifying anti-rheumatic drugs (bDMARDs) available, comparisons are important for treatment decisions. At week 24 of the SPIRIT H2H study in patients with active PSA, IXE showed superiority to ADA for the simultaneous achievement of ACR50 and PASI100. Here we report the 52-week efficacy outcomes including individual ACR components and in subgroups +/- concomitant methotrexate (MTX). Methods SPIRIT H2H (NCT03151551) was a 52-week, multicentre, open-label, blinded-assessor study of bDMARD naïve patients with active PSA (defined as swollen joint count ≥3/68, and tender joint count ≥3/66), with a body surface area (BSA) ≥3% and inadequate response to conventional synthetic (cs)-DMARDs. Patients were randomised 1:1 to IXE or ADA stratified by concomitant csDMARD use and the presence of moderate-to-severe psoriasis (defined as Psoriasis Area and Severity Index [PASI] ≥12 combined with a static Physician Global Assessment ≥3 and BSA ≥10%). Patients received approved label dosing of assigned treatment dependent on presence/absence of moderate-to-severe psoriasis. Primary outcome was achievement of simultaneous ACR50 + PASI100; secondary outcomes were achievement of PASI100, ACR20/50/70 and changes in individual ACR component scores. Data were analysed using logistic regression with non-responder imputation for missing data. Results Baseline characteristics were balanced across treatment groups. At week 52, a significantly larger percentage of IXE- vs. ADA-treated patients achieved simultaneous ACR50 + PASI100 and PASI100, consistent with 24-week results (table). IXE performed at least as well as ADA at week 52 for all other outcomes (table). With/without MTX, IXE efficacy was consistent at week 52 across ACR20/50/70 with a significantly greater achievement of simultaneous ACR50 + PASI100 and ACR70 (table). IXE- versus ADA-treatment resulted in comparable changes from baseline for each individual ACR component at week 52. Safety was consistent with previous reports. Conclusion In patients with PSA, treatment with IXE versus ADA resulted in a significantly greater achievement of simultaneous skin and joint improvement at week 52, consistent with week 24 results. At week 52 consistent efficacy was shown for IXE when used with/without MTX. Disclosures C.J. Edwards: Consultancies; Celltrion, Abbvie, Samsung. Honoraria; Abbvie, BMS, Biogen, Chugai, Fresenius, Gilead, Janssen, Lilly, Pfizer, Roche, Samsung, UCB. Member of speakers’ bureau; Abbvie, BMS, Biogen, Chugai, Fresenius, Gilead, Janssen, Lilly, Pfizer, Roche, Samsung, UCB. Grants/research support; Pfizer, Biogen, Abbvie. A.J. Bradley: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. M.H. Nassab: Other; Full time employee of Eli Lilly. B. Möller: None. K.P. Machold: Honoraria; Arsanis, Astro, Baxter, BMS, Celgene, Eli-Lilly, MSD, Pfizer, Roche, Novartis, Sandoz. Member of speakers’ bureau; MSD, Pfizer, BMS, Janssen-Cilag, Sandoz, Novartis, Eli-Lilly. Grants/research support; AbbVie, BMS, Eli-Lilly, Novartis, MSD, Pfizer, Sanofi-Aventis, UCB. C. Sapin: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. R. Ranza: Consultancies; Abbvie, Novartis, Lilly, Pfizer, Janssen. Member of speakers’ bureau; Abbvie, Novartis, Lilly, Pfizer, Janssen. Grants/research support; Abbvie, Novartis, Pfizer, Janssen. S.L. Leage: Other; Full time employee of Eli Lilly.

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P204 Effect of baricitinib on functional impairment in RA patients with moderate disease activity and an inadequate response to conventional DMARDs

Rheumatology ◽

10.1093/rheumatology/keaa111.199 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Bruce Kirkham ◽

Elena Nikiphorou ◽

Pedro López-Romero ◽

Ilias Kouris ◽

Thorsten Holzkaemper ◽

...

Keyword(s):

Disease Activity ◽

Physical Function ◽

Stock Ownership ◽

Inadequate Response ◽

Full Time ◽

Research Support ◽

Moderate Disease ◽

Conventional Dmards ◽

Full Time Employee ◽

Moderate Disease Activity

Abstract Background In RA, disease activity correlates with physical function and there is a link between joint damage and functional disability. In many countries, RA patients with inadequate response (IR) to MTX or other conventional DMARDs (cDMARDs) are not eligible for potentially more effective treatments, such as biologic or targeted synthetic DMARDs (tsDMARDs), unless they have high disease activity (HDA). Thus, managing RA patients with persistent moderate disease activity (MDA) despite cDMARD treatment poses a problem. Baricitinib (BARI) is a tsDMARD approved for the treatment of moderate to severe RA in adults. This post-hoc analysis assessed if RA patients with MDA benefit from improved physical function with BARI treatment to the same extent as patients with HDA. Methods Patients analysed were from the modified intention-to-treat populations in the BARI phase 3 studies RA-BEAM (MTX-IR) and RA-BUILD (cDMARD-IR) with moderate to severe disability (HAQ-Disability Index [HAQ-DI] score ≥1), MDA (Simplified Disease Activity Index [SDAI] score 11.1-26.0) or HDA (SDAI score>26.0) and non-missing SDAI data at baseline. All patients fulfilled ACR criteria for RA. Patients from RA-BEAM received BARI 4 mg + MTX once daily (n = 396), adalimumab 40 mg every 2 weeks + MTX (n = 270) or placebo (PBO) + MTX (n = 390); patients from RA-BUILD received BARI 4 mg (n = 189) or 2 mg (n = 186) or PBO (n = 185). Multivariable linear regression (MLR) models were used to estimate mean HAQ-DI scores at baseline and week 24 (W24) for the treatment arms stratified by baseline disease activity (MDA or HDA SDAI). Age, RA duration, BMI, high-sensitivity CRP, baseline SDAI disease activity (MDA/HDA), treatment and treatment-by-baseline SDAI interaction were included as covariates. The MLR model for HAQ-DI at (W24) was further adjusted by baseline HAQ-DI. Results In patients from RA-BEAM with MDA at baseline, the mean adjusted HAQ-DI score at W24 was greater in PBO (1.314) than in BARI 4 mg (0.843) patients (Δ = 0.472; p = 0.001). A similar pattern of improved physical function with BARI was seen in RA-BUILD, but the adjusted mean difference in HAQ-DI score between PBO (1.376) and BARI 4 mg (1.113) was not statistically significant (Δ = 0.263; p = 0.109). In patients with HDA at baseline, the W24 mean adjusted HAQ-DI score was 0.443 points greater (p < 0.001) with PBO (1.387) than with BARI 4 mg (0.944) in RA-BEAM, and 0.257 points greater (p < 0.001) in RA-BUILD. Conclusion MTX-IR and/or cDMARD-IR RA patients with MDA and moderate to severe disability at baseline treated with BARI showed a similar pattern of improvement in physical function vs. PBO-treated patients to that seen in patients with HDA, supporting early use of BARI in MDA patients. As for those with HDA, patients with persistent MDA despite MTX and/or other cDMARD treatment could benefit from access to biologic and tsDMARDs to prevent disability progression. Disclosures B. Kirkham: Consultancies; AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Pfizer. Grants/research support; Eli Lilly, Novartis. E. Nikiphorou: Honoraria; Pfizer, Sanofi, Gilead, Celltrion, Eli Lilly. P. López-Romero: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. I. Kouris: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. T. Holzkaemper: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. L. Zaremba-Pechmann: Other; contractor for Eli Lilly and Company. I. de la Torre: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. P.C. Taylor: Consultancies; AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Roche, Sanofi, Nordic Pharma, Fresenius, UCB. Grants/research support; Celgene, Galapagos, Janssen, Eli Lilly.

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O09 Pooled safety analyses from Phase 3 studies of filgotinib in patients with RA

Rheumatology ◽

10.1093/rheumatology/keaa110.008 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

David Walker ◽

Kevin Winthrop ◽

Mark C Genovese ◽

Bernard G Combe ◽

Yoshiya Tanaka ◽

...

Keyword(s):

Safety Data ◽

Study Drug ◽

Janus Kinase ◽

Tender Joint Count ◽

Stock Ownership ◽

Tolerability Profile ◽

Inadequate Response ◽

Control Groups ◽

Research Support ◽

Phase 3

Abstract Background Filgotinib (FIL) is an oral, selective janus kinase 1 inhibitor under development for the treatment of rheumatoid arthritis (RA) and other inflammatory diseases. Safety and efficacy of FIL was investigated in the FINCH clinical program, which includes three Phase 3, summarized, summarized studies in patients with moderate to severely active RA. FINCH1: patients with inadequate response to MTX (NCT02889796); FINCH2: patients receiving conventional disease-modifying antirheumatic drugs (csDMARDs) with inadequate response to biological DMARDs (NCT02873936); FINCH3: MTX-naïve patients initiating MTX ± FIL, or receiving FIL monotherapy (NCT02886728). We present pooled safety data up to 24 weeks (W24). Methods The FINCH studies enrolled patients with RA (2010 ACR/EULAR criteria), ≥6 swollen joints and ≥6 tender joints at screening and Day 1. Safety analyses included patients receiving ≥1 dose of study drug. Patients in FINCH 1 and 2 who did not experience at least a 20% improvement in both swollen joint count and tender joint count by W14 discontinued study drug and switched to standard of care. W24 safety data from all studies were aggregated and ummarized. Key safety endpoints were treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of interest, deaths and treatment-emergent laboratory abnormalities. Results 3,452 patients were evaluated; 2,088 received FIL. At W24, the frequency of TEAEs and TEAEs of interest were similar for those who received FIL and those in the control groups (Table 1). Most TEAEs were infections. Laboratory abnormality rates were similar between FIL and control groups, and were mild to moderate (grades 1 and 2). Overall, the frequency of major adverse cardiac events, herpes zoster virus, deep vein thrombosis and pulmonary embolism was low, and similar across groups. Conclusion Pooled data from this large database highlights the favourable safety and tolerability profile of FIL in patients with RA both as monotherapy and in combination with MTX/csDMARD. Disclosures D. Walker: Other; Received support from Lilly, Pfizer, Novartis and Roche. K. Winthrop: Grants/research support; Received grants for clinical research from Bristol-Myers Squibb Company and Insmed Incorporated. Other; Received support from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Eli Lilly & Co., MSD, Novartis, Pfizer, Roche-Chugai, Sanofi, and UCB. M.C. Genovese: Other; Gilead Sciences Inc., Galapagos NV, AbbVie Inc. Eli Lilly and Company, Pfizer. B.G. Combe: Honoraria; Honoraria from AbbVie, BMS, Gilead, Janssen, Eli Lilly and Co., MSD, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB. Y. Tanaka: Honoraria; Received from Daiichi-Sankyo, Astellas, Chugai, Eli Lilly and Co., Pfizer, AbbVie, YL Biologics, BMS, Takeda, Misubishi-Tanabe, Novartis, Eisai, Janssen, Teijin. Grants/research support; Received grant support from Asahi-Kasei, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, BMS, UCB, Daiichi-Sankyo, Eisai, and Ono. A. Kivitiz: Consultancies; Consultant for AbbVie, Celgene, Horizon, Janssen, Merck, Novartis, Pfizer, UCB, Genzyme,Sanofi, Regeneron, SUN Pharma Advanced Research, Boehringer Ingelheim and Flexion. Shareholder/stock ownership; Shareholder of Novartis. F. Matzkies: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. B. Bartok: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. L. Ye: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Gilead Sciences, Inc. Shareholder/stock ownership; Gilead Sciences, Inc. C. Tasset: Corporate appointments; Employee of Galapagos NV. J.S. Sundy: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. E. Keystone: Consultancies; AbbVie, Amgen, AstraZeneca Pharma, Biotest, BMS Canada, Celltrion, Crescendo, Bioscience, F.Hoffman-La Roche Inc., Genentech, Janssen, Eli Lilly and Co., Merck, Pfizer, PuraPharm, Sandoz,, Sanofi-Aventis, Sanofi- Genzyme Samsung Bioepsis, and UCB. Other; AbbVie, Amgen, AstraZeneca Pharma, Biotest, BMS Canada, Celltrion, Crescendo, Bioscience, F.Hoffman-La Roche Inc., Genentech, Janssen, Eli Lilly and Co., Merck, Pfizer, PuraPharm, Sandoz,, Sanofi-Aventis, Sanofi-Genzyme, Samsumg Bioepsis, and UCB. R. Westhovens: Corporate appointments; An investigator and advisor for Celltrion and Galapagos/Gilead. W. Rigby: Consultancies; Consultancy for Gilead. G.R. Burmester: Consultancies; Consultancy from AbbVie, Gilead, Eli Lilly, and Pfizer. Honoraria; Honoraria from AbbVie, Gilead, Eli Lilly, and Pfizer.

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P133 Filgotinib in patients with RA with inadequate response to methotrexate: FINCH 1 52-week efficacy and patient reported outcomes data

Rheumatology ◽

10.1093/rheumatology/keab247.129 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

David Walker ◽

Alan Kivitz ◽

Yoshiya Tanaka ◽

Susan Lee ◽

Lei Ye ◽

...

Keyword(s):

Short Form ◽

Pain Scale ◽

Janus Kinase ◽

Controlled Study ◽

Stock Ownership ◽

Inadequate Response ◽

Research Support ◽

Double Blind ◽

Sf 36 ◽

Patient Reported

Abstract Background/Aims Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy, safety and patient reported outcome (PRO) data in patients (pts) with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX-IR). We report data through week 52 (W52) of the FINCH 1 study. Primary outcome results at week (W)12 and W24 were previously reported. Methods This global, phase 3, double-blind, active- and placebo (PBO)-controlled study randomised MTX-IR pts with active RA on a background of stable MTX 3:3:2:3 to oral FIL 200 mg or FIL 100 mg once daily, subcutaneous adalimumab (ADA) 40 mg every 2W, or PBO up to W52; pts receiving PBO at W24 were re-randomised to FIL 100 or 200 mg. Efficacy was assessed using clinical, radiographic, and pt-reported outcomes; W52 comparisons were not adjusted for multiplicity, and nominal p-values are reported. Safety endpoints included types and rates of adverse events (AEs) and laboratory abnormalities. PRO assessment included the HAQ-DI and VAS pain scale, SF-36, and FACIT-Fatigue questionnaire. Change from baseline (CFB) at various time points was assessed up to W52 for each treatment group. Results Of 1,755 treated pts, 1,417 received study drug through W52. FIL efficacy was sustained through W52 with DAS28(CRP) <2.6 remission rates of 54%, 43%, and 46% of pts receiving FIL 200 and 100 mg and ADA, respectively, (nominal p for FIL 200 vs ADA = 0.024) (Table 1). FIL safety profile through W52 was consistent with W24 data. AEs of interest were infrequent and balanced among treatments. As early as W2, through W24, pts receiving either dose of FIL experienced nominally significantly greater (p < 0.001) CFB in HAQ-DI and VAS pain scale than those receiving PBO. These improvements were sustained up to W52. In general, CFB for HAQ-DI, VAS pain scale, and FACIT-Fatigue observed for the FIL groups was higher or comparable to ADA through W52 (Table 1). P133 Table 1:Efficacy and PRO outcomes at Week 52Efficacy OutcomeFIL 200 mg (n = 475)FIL 100 mg (n = 480)ADA (n = 325)ACR20/50/70, %a78/62/4476/59/3874/59/39DAS28(CRP) ≤3.2, %a66+5959mTSSb,c0.18+++0.450.61HAQ-DIc,d−0.93+−0.85−0.85VAS pain scalec,d−42−40−40SF-36 PCSc,d12.011.512.4FACIT-Fc,d11.912.211.7aNon-responder imputation,bLeast squares mean change from baseline,cObserved case,dMean change from baseline.+nominal p < 0.05, +++nominal p < 0.001 vs ADA ADA, adalimumab; FACIT-F, Functional Assessment of Chronic Illness Therapy Fatigue; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire-Disability Index; mTSS, modified van der Heijde TSS; SF-36, 36-Item Short Form Survey. Conclusion Through W52, both FIL 200 and 100 mg showed sustained efficacy, rapid and sustained improvement in patient QoL based on clinical and pt-reported outcomes and were well tolerated in MTX-IR pts with RA. Disclosure D. Walker: Consultancies; Lilly, Pfizer, Novartis, Roche. A. Kivitz: Consultancies; AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences, Inc. Shareholder/stock ownership; Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences, Inc., Novartis. Member of speakers’ bureau; Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. Y. Tanaka: Honoraria; AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead Sciences, Inc., GlaxoSmithKline, Janssen, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sanofi and Y. Grants/research support; AbbVie, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Takeda and UCB. S. Lee: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. L. Ye: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. H. Hu: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. F. Matzkies: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. B. Bartok: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. B. Bartok: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. Y. Guo: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. J.S. Sundy: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. A. Jahreis: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. R. Besuyen: Shareholder/stock ownership; Galapagos BV. Other; Employee of Galapagos BV. B. Combe: Other; Reports research support, honoraria, consulting and speaker fees from AbbVie; Bristol-Myers Squibb; Eli Lilly & Co.; Gilead Sciences, Inc.; Janssen; Novartis; Pfizer; Roche-Chugai; Sanofi; and UCB. D. van der Heijde: Consultancies; AbbVie; Amgen; Astellas; AstraZeneca; Bristol-Myers Squibb; Boehringer Ingelheim; Celgene; Cyxone; Daiichi-Sankyo; Eisai; Eli Lilly & Co.; Galapagos; Gilead Sciences, Inc.; Glaxo-Smith-Kline; Janssen;, Merck; Novartis; Pfizer; Regeneron; Roche; Sanofi; Takeda; and UCB. J. Simon-Campos: None. H.S.B. Baraf: Grants/research support; AbbVie; Horizon; Gilead Sciences, Inc.; Pfizer; Janssen; and Merck. U. Kumar: None. C. Tasset: Shareholder/stock ownership; Galapagos NV. Other; Employee of Galapagos NV. N. Mozaffarian: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. R.B.M. Landewé: Consultancies; AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Gilead Sciences, Inc.; Galapagos NV; Novartis; Pfizer; and UCB. S. Bae: None. E. Keystone: Other; Reports research support, consulting, and speaker fees from AbbVie; Amgen; AstraZeneca; Bristol-Myers Squibb; Celltrion; F. Hoffman-La Roche Ltd.; Genentech, Inc; Gilead Sciences, Inc.; Janssen; Lilly, ; Merck; Myriad Autoimmune; Pfizer; PuraPharm; Sandoz; Sanofi-Genzyme; Samsung Bioepsis; and UCB. P. Nash: Other; Reports research support, consulting, and speaker and personal fees from AbbVie; Bristol-Myers Squibb; Celgene; Eli Lilly & Co.; Gilead Sciences, Inc; Janssen; Merck Sharp & Dohme; Novartis; Pfizer;, Roche; Sanofi; and UCB.

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Assessing Back Pain: Does the Oswestry Disability Questionnaire Accurately Measure Function in Ankylosing Spondylitis?

The Journal of Rheumatology ◽

10.3899/jrheum.091240 ◽

2010 ◽

Vol 37 (6) ◽

pp. 1211-1213 ◽

Cited By ~ 1

Author(s):

FINBAR D. O’SHEA ◽

REENA RIARH ◽

ANNEPA ANTON ◽

ROBERT D. INMAN

Keyword(s):

Back Pain ◽

Ankylosing Spondylitis ◽

Pain Score ◽

Global Assessment ◽

Patient Global Assessment ◽

Assessment Score ◽

Pain Scores ◽

Disability Questionnaire ◽

The Mean ◽

Oswestry Disability Questionnaire

Objective.To determine whether the Oswestry Disability Questionnaire (ODQ) can be used to assess the degree of pain or disability in patients with ankylosing spondylitis (AS).Methods.The ODQ was administered to a cohort of patients with AS. The resulting pain scores were correlated to the conventional measures in AS, the Bath AS Disease Activity Index and Functional Index (BASDAI and BASFI), as well as the Total and Nocturnal Back Pain scores, and the patient global assessment score.Results.A total of 49 patients with AS were assessed (38 men, 11 women), mean age 40 years (range 17–68). The mean ODQ score was 40/100 (range 0–92), the mean BASDAI 3.7/10 (range 0–9.5), the mean BASFI 3.3/10 (range 0–9.7), the mean total back pain score 3.7/10 (range 0–10), and the mean patient global assessment score 3.6/10 (range 0–10). Correlation between the ODQ and the traditional AS outcome measures was very good, with a correlation coefficient of r = 0.73 (BASFI) and r = 0.70 (BASDAI). Correlations between the ODQ and the total back pain score (r = 0.70) and the patient self-reported global assessment (r = 0.61) were good.Conclusion.The strong correlations between the ODQ and BASFI and BASDAI indicate that it identifies both activity and function domains in AS. This is the first demonstration of a role for this outcome measure in the assessment of patients with AS.

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POS0907 EFFECT OF UPADACITINIB ON REDUCING PAIN IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO NONSTEROIDAL ANTI-INFLAMMATORY DRUGS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.604 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 712-713

Author(s):

A. Deodhar ◽

X. Baraliakos ◽

I. Mcinnes ◽

K. De Vlam ◽

L. Bessette ◽

...

Keyword(s):

Back Pain ◽

Ankylosing Spondylitis ◽

Pain Reduction ◽

Inadequate Response ◽

Research Support ◽

Open Label ◽

Time Points ◽

Point Reduction ◽

Period 2 ◽

Over Time

Background:Pain is a debilitating symptom of ankylosing spondylitis (AS) and negatively impacts patient (pt) lives. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor engineered for increased selectivity for JAK1 over JAK2, JAK3, and tyrosine kinase 2, 1 showed significant efficacy vs placebo (PBO) in the randomized phase 2/3 SELECT-AXIS 1 study in active AS.2Objectives:To evaluate the efficacy of UPA on multiple pain assessments through 64 weeks (wks).Methods:SELECT-AXIS 1 (NCT03178487) enrolled adults with active AS, who had an inadequate response, intolerance or contraindications to ≥2 NSAIDs, were biologic DMARD naive and met the modified New-York Criteria. Pts were randomized 1:1 to UPA 15 mg once daily (QD, n=93) or PBO (n=94) for 14 wks (Period 1), followed by open-label UPA 15 mg QD during 90-wk extension (Period 2); reported here are data through wk 64. Pain endpoints included the proportion of pts achieving ≥30%/≥50%/≥70% reduction in Pt’s Global Assessment (PGA) of pain on a 0–10 numeric rating scale (NRS), minimal clinically important difference (MCID, defined as ≥1 point reduction or ≥15% reduction from baseline [BL]) in PGA of pain, and much better improvement (MBI, defined as ≥2 point reduction and ≥33% reduction from BL) in PGA of pain. In addition, mean change from baseline in PGA of pain, BASDAI questions 2 (neck/back/hip pain) and 3 (peripheral pain/swelling), and pt’s assessment of back pain and nocturnal back pain NRS scores (NRS 0–10) were assessed. Non-responder imputation (binary endpoints) and mixed-effects model for repeated measurements (continuous endpoints) were used for missing data/dropouts in Period 1; as-observed analysis was used for Period 2.Results:A significantly higher proportion of pts receiving UPA vs PBO achieved reductions in all PGA of pain assessments as early as wk 2 that was sustained at all time points in Period 1; the only exception was ≥70% reduction in PGA of pain that was significant at wk 4 and sustained thereafter (Figure 1). For ≥30%/≥50%/≥70% reduction and MBI, the response rate increased over time with UPA; the difference for UPA vs PBO also continued to increase over time for ≥50% and ≥70% reduction endpoints. For MCID, an increase from BL to wk 2 was observed and plateaued thereafter. The mean change from BL in PGA of pain, BASDAI Q2, back pain, and nocturnal back pain NRS scores were significantly greater for UPA vs PBO at all time points in Period 1; BASDAI Q3 was significant at wk 8 and 14 (Figure 1). The effect of UPA on pain reduction was sustained through wk 64. PBO pts who switched to open-label UPA at wk 14 generally reached the same level of pain reduction as those initially randomized to UPA (Figure 1).Conclusion:In pts with active AS and an inadequate response/contraindication to NSAIDs, a greater proportion of patients treated with UPA achieved rapid, significant, and clinically meaningful reductions in pain vs PBO through 14 wks across multiple pain assessments. The reductions in pain were sustained over time, and pts who switched from PBO to UPA reached the same level of improvement as the continuous UPA group.References:[1]Parmentier JM, et al. BMC Rheumatology. 2018;2(23).[2]van der Heijde D, et al. Lancet. 2019;394(10214):2108-2117.Acknowledgements:AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by M Hovenden and J Matsuura of ICON plc and was funded by AbbVie.Disclosure of Interests:Atul Deodhar Speakers bureau: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Consultant of: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Grant/research support from: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Xenofon Baraliakos Consultant of: Novartis, Pfizer AbbVie, Eli Lilly, UCB Pharma, Galapagos Janssen, Celgene and Amgen, Grant/research support from: Novartis, Pfizer AbbVie, Eli Lilly, UCB Pharma, Galapagos Janssen, Celgene and Amgen, Iain McInnes Consultant of: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, Kurt de Vlam Speakers bureau: Celgene Eli Lilly, Galapagos, Novartis, and UCB, Consultant of: Celgene, Eli Lilly, Galapagos, Novartis, and UCB, Grant/research support from: Celgene and Galapagos, Louis Bessette Speakers bureau: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, and Sanofi, Consultant of: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Sanofi, Gilead, Grant/research support from: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Sanofi, and Gilead, anna maniccia Shareholder of: AbbVie, Employee of: AbbVie, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, Christopher Saffore Shareholder of: AbbVie, Employee of: AbbVie, Tianming Gao Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie, Employee of: AbbVie, Andrew Ostor Consultant of: AbbVie, BMS, Roche, Janssen, Lilly, Novartis, Pfizer, UCB, Gilead, and Paradigm

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Changes in Back Pain Scores after Bariatric Surgery in Obese Patients: A Systematic Review and Meta-Analysis

Journal of Clinical Medicine ◽

10.3390/jcm10071443 ◽

2021 ◽

Vol 10 (7) ◽

pp. 1443

Author(s):

Froukje W. Koremans ◽

Xiaolong Chen ◽

Abhirup Das ◽

Ashish D. Diwan

Keyword(s):

Bariatric Surgery ◽

Back Pain ◽

Pain Score ◽

Meta Analysis ◽

Study Groups ◽

Control Group ◽

Obese Patients ◽

Weight Changes ◽

Pain Scores ◽

The Impact

Bariatric surgery produces significant and quantifiable reductions in back pain. However, there is a lack of information on the association of weight changes after bariatric surgery with changes in pain score. We aim to evaluate the impact of bariatric surgery on back pain in obese patients and to address the association between changes in body mass index (BMI) and pain score. In obese patients eligible for bariatric surgery, the changes in pre- and post-operative pain scores, assessed by the Numeric Rating Pain Scale (NPS) or Visual Analogue Scale (VAS), were considered as primary outcomes. Mean difference (MD) and their 95% confidence intervals (CI) were evaluated. Eight cohort studies were included in the analysis of 298 obese patients undergoing bariatric surgery. All studies showed a reduction in back pain, with a mean change of −2.9 points in NPS and of −3.8 cm in VAS. There was a significant reduction in back pain (NPS: (MD = −3.49) (95% CI = −3.86, −3.12); VAS: MD = −3.75, (95% CI = −4.13, −3.37)) and BMI (MD = −12.93, (95% CI = −13.61, −12.24)) following bariatric surgery. No significant relationship between BMI change and decrease in clinical scores could be established. However, it was evident that bariatric surgery had a significant effect on back pain scores in severely obese patients. Ideally, a prospective study including spinal imaging, inflammatory markers, a longer follow-up period, and larger study groups with a randomized control group needs to be performed.

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