AB0758 REAL-WORLD EFFICACY AND SAFETY OF APREMILAST IN BELGIAN PATIENTS WITH PSORIATIC ARTHRITIS: FINAL ANALYSIS OF THE MULTICENTRE, PROSPECTIVE APOLO STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1676-1676
Author(s):  
K. De Vlam ◽  
A. Nzeusseu Toukap ◽  
M. J. Kaiser ◽  
J. Vanhoof ◽  
P. Remans ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Research And Development ◽  
Disease Activity ◽  
Real World ◽  
Global Assessment ◽  
Tender Joint Count ◽  
Efficacy And Safety ◽  
Research Support ◽  
Efficacy Population ◽  
Assessment Of Disease Activity

Background:Real-world evidence on the efficacy and safety for patients (pts) with psoriatic arthritis (PsA) treated with apremilast (APR) is lacking but required to understand the uptake and potential of the drug.Objectives:To assess the efficacy and safety of APR in pts with active PsA from routine clinical practice in Belgium.Methods:In this multicentre, prospective study, the primary endpoint was the PsA Response Criteria (PsARC) response 6 months after APR initiation, defined as improvement in ≥2 (at least 1 must be joint swelling or tenderness) and no worsening in any of 4 criteria: swollen joint count (SJC [0-66]), tender joint count (TJC [0-68]), Physician’s Global Assessment of Disease Activity and Pt’s Global Assessment of Disease Activity. Other endpoints included the 12-item PsA Impact of the Disease (PsAID12) questionnaire, Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician’s and Pt’s Numerical Rating Scale assessing disease activity for the most affected joint, psoriasis-involved body surface area, enthesitis, dactylitis and pain.Results:In total, 107 pts were enrolled and included in the baseline (BL) demographics/disease characteristics and safety analyses. The efficacy population comprised 69 pts (pts who started APR ≤30 days before inclusion in the study and completed ≥150 days of treatment). Mean age was 53 years, mean body mass index was 29 kg/m2and 56% were female. Mean duration of PsA was ≈8 years (87.1 months). One-third of pts presented with short disease duration (time since diagnosis of PsA: ≤2 years); 84% were biologic naive. The most frequently reported comorbidities were cardiovascular disease (30%) and hypercholesterolemia (24%). At BL, mean (SD) SJC was 8.0 (6.5); mean (SD) TJC was 14.2 (12.5). Pts from the efficacy population were representative of the overall population. Fifty-four pts (60%) continued APR treatment for 6 months; 38 (36%) had discontinued APR (insufficient efficacy: n=15; adverse events [AEs]: n=16; intolerance: n=6; other reason: n=1). AEs were mostly mild or moderate in nature and consistent with APR’s known safety and tolerability profile.1At Month 6, data were available for 49 pts, 65% of whom were PsARC responders. Mean change from BL in SJC was −5.23, with improvements (defined as ≥30% decrease per PsARC) observed in 80% of pts; 42% had no swollen joints at 6 months. Comparable results were seen for TJC, with mean changes from BL of −5.34 and improvements observed in 71% of pts; 27% had no tender joints at 6 months. Among pts with enthesitis at BL (n=21), 43% achieved a score of 0 by Month 6. Among pts with dactylitis at BL (n=18), 83% achieved a count of 0 by Month 6. Impact of PsA on quality of life (QoL) from the pt’s perspective was assessed using the PsAID12 questionnaire and characterized by physical and psychological domains. After 3 and 6 months of treatment, 33% and 50% of pts with PsAID >4 at BL (n=60) achieved PsAID12 ≤4, respectively (cutoff value for Pt Acceptable Symptom State2). Improvements were observed in all 12 domains at Months 3 and 6 compared with BL (Figure). In all, 66% of pts showed a decrease ≥0.35 in HAQ-DI; the proportion of pts reaching a global HAQ-DI <0.5 increased over time (14% at 3 months; 20% at 6 months).Conclusion:Results from APOLO, a study assessing the impact of APR in routine settings, indicated that APR is associated with rapid and sustained improvements in PsA signs and symptoms and QoL in an important proportion of pts. Safety and tolerability were consistent with the known profile of APR.References:[1]Kavanaugh A, et al. Arthritis Res Ther. 2019;21:118. 2. Gossec L, et al. Ann Rheum Dis. 2014;73:1012-1019.Disclosure of Interests:Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Adrien Nzeusseu Toukap Grant/research support from: AbbVie, Celgene Corporation, Janssen, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, UCB – consultant, Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, UCB – advisory board member, Marie-Joëlle Kaiser Consultant of: Celgene Corporation – consultant, Johan Vanhoof: None declared, Philip Remans: None declared, Silvana Di Romana: None declared, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Virginie Vanhoof Employee of: Amgen Inc. – employment; Celgene BeLux – employment at the time of study conduct, Rik Lories Grant/research support from: AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Samumed and UCB – grant/research support (on behalf of Leuven Research and Development), Consultant of: AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Samumed and UCB – consultant (on behalf of Leuven Research and Development), Speakers bureau: AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Samumed and UCB – speaker (on behalf of Leuven Research and Development)

scholarly journals SAT0432 EFFECT OF SEX ON DISEASE CHARACTERISTICS AND DISEASE IMPACT IN PATIENTS WITH PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE REAL-WORLD, OBSERVATIONAL MULTINATIONAL PsABio COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1171.1-1173
Author(s):  
M. T. Nurmohamed ◽  
I. Van der Horst-Bruinsma ◽  
A. W. Van Kuijk ◽  
S. Siebert ◽  
P. Bergmans ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Physical Functioning ◽  
Real World ◽  
Comprehensive Treatment ◽  
Diagnosis Delay ◽  
Health State ◽  
Research Support ◽  
Disease Characteristics ◽  
Disease Impact

Background:Female sex has been associated with more severe disease and poorer treatment outcomes in PsA. These observations are often based on small populations or national cohorts/registries.Objectives:To investigate the effects of sex on disease characteristics and disease impact in PsA, using data of 929 consecutive patients (pts) from PsABio.Methods:PsABio is a real-world, non-interventional European study in PsA pts treated with UST or TNFi based on their rheumatologist’s choice. Observed male and female baseline (BL) data were described and compared using 95% CI.Results:Women in PsABio (n=512 [55%]) were numerically older than men (mean [SD]: 50.5 [12.7] / 48.7 [12.3] years, respectively). Women were more obese (BMI >30), % (95% CI): F: 35 (30, 39), M: 24 (20, 29), men more overweight (BMI >25–30): F: 31 (27, 36), M:51 (46, 57). Age at diagnosis, delay from first symptom to diagnosis, and disease duration were similar for both sexes.Women entered PsABio more often on 3rd line treatment, whereas men started on 1st-line biologic treatment more often (F/M 1st line 47%/55%; 2nd line 34%/33%; 3rd line 20%/12%). Numerically, concomitant MTX was given more often to women vs men (32% vs 27%). At BL, 60% of women and 64% of men were on NSAIDs; 7.9% and 2.5% on antidepressant drugs. Women had significantly more comorbidities, with numerically more cardiovascular disease and anxiety/depression, and 3 times more IBD.Women had significantly higher 68 tender joint counts (TJC): 13.0 vs 10.4, while 66 swollen joint counts were not significantly different: 5.8 vs 5.5. Axial or combined axial-peripheral disease was similarly frequent, in 29% of women and 26% of men (Figs. 1, 2).Clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) was higher in women (31.8 vs 27.3); pt-reported levels of pain, global disease activity (VAS scales) and higher TJC contributed to this. While enthesitis prevalence (based on Leeds Enthesitis Index) was comparable, men had significantly more frequent dactylitis, nail disease and worse skin psoriasis. At BL, 3.4% of women vs 7.1% of men, were in MDA.Regarding physical functioning (HAQ-DI), impact of disease (PSAID-12) and quality of life (EQ5D-3L health state), women with PsA starting a biologic (b)DMARD, expressed significantly greater negative impact and more limitations due to their disease (Fig. 2).Conclusion:In routine care, women with PsA starting a bDMARD presented with worse outcomes over a range of assessments compared with men (higher pt-reported pain and disease activity, TJC, and worse physical functioning and QoL), while men had worse dactylitis and psoriasis. Follow-up analysis will report whether the effects of biologic therapy are different in both sexes. The increased prevalence of associated features related to pain and impact on functioning and QoL may indicate the need for a more comprehensive treatment approach for women to avoid unnecessary and premature bDMARD stop or switch.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Arno WR van Kuijk Grant/research support from: Janssen, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Wim Noel Employee of: Janssen Pharmaceuticals NV, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

FRI0362 COMPARATIVE EFFECTIVENESS OF USTEKINUMAB (UST) AND TNF INHIBITORS (TNFI) IN PATIENTS WITH PSORIATIC ARTHRITIS (PSA) IN THE REAL-WORLD, MULTINATIONAL PSABIO STUDY: 12-MONTH FOLLOW-UP

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 778-779
Author(s):  
J. S. Smolen ◽  
S. Siebert ◽  
T. Korotaeva ◽  
P. Bergmans ◽  
K. De Vlam ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Activity Index ◽  
Treatment Options ◽  
Disease Activity Index ◽  
Rapid Screening ◽  
Research Support ◽  
Real World Data

Background:Among treatment options for PsA, IL-12/23 inhibition with UST was the first new biologic mode of action after TNFi. Few real-world data comparing UST with TNFi are available.Objectives:Comparison of UST and TNFi treatment effectiveness within the prospectively followed PsABio cohort at 12-month (mo) follow-up.Methods:The PsABio study (NCT02627768) evaluates effectiveness, tolerability and persistence of 1st, 2nd or 3rd-line UST or TNFi in PsA. Proportions of patients (pts) reaching MDA/very low disease activity (VLDA) and clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) LDA/remission are described. Comparison across UST and TNFi cohorts was done on last observation carried forward up to 12 (±3) mo, with non-response imputation for pts who had stopped/switched initial treatment. Logistic regression analysis was used, including propensity score (PS) analysis to adjust for imbalanced prognostic baseline (BL) covariates: country, age, sex, BMI, smoking (yes/no), comorbidities (cardiovascular/metabolic syndrome), PsA type (axial, polyarticular, oligoarticular), psoriasis body surface area (BSA), disease duration, cDAPSA, 12-item PsA Impact of Disease (PsAID-12), dactylitis, enthesitis, Fibromyalgia Rapid Screening Tool (FiRST) score, line of biologic (b)DMARD, synthetic DMARD use, and steroid or NSAID use.Results:Of 929 eligible pts, 893 had evaluable data at BL and at follow-up; 438 (95.6%) were treated with UST and 455 (96.6%) with TNFi (including stoppers/switchers). UST and TNFi groups had BL differences in mean age (51.0 vs 48.5 years, respectively), concurrent comorbidities (68.7% vs 60.9%), time since diagnosis (7.5 vs 6.2 years), line of treatment (1st-line 45.0% vs 55.2%; 3rd-line 20.5% vs 12.1%), NSAID use (54.8% vs 68.8%), concomitant MTX use (29.9% vs 42.0%) and psoriasis skin involvement (BSA >10% in 26.6% vs 14.8%).In 714 pts with available data, mean (standard deviation) BL cDAPSA was 30.6 (20.2; n=358) for UST and 29.3 (18.6; n=356) for TNFi. Observed data showed differences in proportion of pts achieving MDA/VLDA and cDAPSA LDA/remission in favour of TNFi, but after PS adjustment for BL differences (such as line of therapy, skin psoriasis, concomitant conventional DMARD, etc.), odds ratios for reaching targets at 12 mo did not significantly differ between UST and TNFi groups (Fig. 1).Comparison of 6- and 12-mo unadjusted data showed sustained MDA/VLDA responses with both UST (21.8%) and TNFi (29.5%), with comparable proportions of additional pts achieving these targets between 6 and 12 mo (17.0% and 20.3%, respectively). Sustained efficacy became lower with successive lines of treatment (data not shown).Conclusion:Various factors, including patient characteristics such as comorbidities, influence the physician’s selection of treatment modality for patients needing a bDMARD. Our real-world results demonstrate differences in observed clinical effectiveness between UST and TNFi. However, after PS adjustment for a number of BL differences, clinical results at 12 mo were comparable between UST and TNFi groups. Data at 12 mo also show sustained response with both UST and TNFi treatment, as well as a similar rate of pts achieving targets after 6 to 12 mo of treatment.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

O24 Concomitant treatment with MTX does not increase the efficacy of ustekinumab or TFNi in PsA: results from the PsABio study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Stefan Siebert ◽  
Elisa Gremese ◽  
Paul Bergmans ◽  
Kurt de Vlam ◽  
Beatriz Joven-Ibáñez ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Concomitant Treatment ◽  
Skin Involvement ◽  
Research Support ◽  
Real World Data ◽  
Low Disease Activity ◽  
Intention To Treat ◽  
Patient Reported

Abstract Background The additional benefit of methotrexate (MTX) as a concomitant treatment in PsA has not been fully elucidated for TNF inhibitors (TNFi) and no real-world data on this currently exist for ustekinumab (UST). We investigated the additive effect of MTX on the ability to reach composite treatment targets beyond monotherapy with UST or TNFi, and the ability to improve patient-reported outcomes in a real-world clinical setting in 8 European countries. Methods The PsABio study (NCT02627768) evaluates persistence, effectiveness and tolerability of 1st, 2nd or 3rd-line UST or TNFi in patients with PsA. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (LDA) or remission, as well as the patient acceptable symptom state (PASS; score ≤4) of the 12-item Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12) were evaluated. Here we present 6-month follow-up data using intention to treat (ITT) analysis; patients who stopped/switched initial treatment were imputed as non-responders. The effect of MTX co-therapy was investigated within UST and TNFi cohorts, as well as between the cohorts, using multivariate logistic regression including interaction terms, and propensity score (PS) analysis to adjust for imbalanced, potentially prognostic, baseline covariates. Results Of 930 patients, data was available for 868 ITT patients, including patients who switched/stopped before 6 months (UST: n = 28/426 [6.6%], TNFi: n = 44/442 [10.0%]). At baseline there were no relevant differences in demographics and disease activity, however there were significant differences in skin involvement as well as csDMARD and NSAID exposure. Co-therapy with MTX did not increase the likelihood of achieving any of the outcomes in either the UST or TNFi cohorts (Table 1). After PS adjustment, co-treatment with MTX did not influence treatment effects differently when added to UST compared with TNFi. concomitant use of csDMARDs other than MTX yielded very similar results. Conclusion In a real-world setting, concomitant treatment with MTX in addition to UST or TNFi was not associated with enhanced effects across a broad variety of disease outcomes, including disease activity, disease impact, and skin involvement within or between treatment cohorts, after PS adjustment for baseline confounders. Disclosures S. Siebert: Consultancies; AbbVie, UCB, Pfizer, Janssen, Boehringer Ingelheim, Celgene, Novartis. Grants/research support; Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim. E. Gremese: Consultancies; AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, Pfizer. P. Bergmans: Shareholder/stock ownership; Johnson & Johnson. Other; Employee of Janssen. K. de Vlam: Consultancies; Johnson & Johnson. B. Joven-Ibáñez: Member of speakers’ bureau; Celgene, Novartis, MSD, Pfizer, AbbVie, Janssen. G. Katsifis: None. T.V. Korotaeva: Consultancies; Pfizer, MSD, Novartis, AbbVie, Celgene, Biocad, Janssen, UCB, Lilly, Novartis-Sandoz. W. Noël: Other; Employee of Janssen. C. Selmi: None. P.P. Sfikakis: None. P. Smirnov: Other; Employee of Janssen. E. Theander: Other; Employee of Janssen. M.T. Nurmohamed: Grants/research support; Pfizer, AbbVie, Roche, BMS, MSD, Mundipharma, UCB, Janssen, Menarini, Lilly, Sanofi, Celgene. L. Gossec: Honoraria; AbbVie, Celgene, Janssen, Lilly, Novartis-Sandoz, Pfizer, Sanofi, UCB. Grants/research support; Pfizer. J.S. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, GlaxoSmithKline, ILTOO Pharma, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB. Grants/research support; AbbVie, Janssen, Lilly, MSD, Pfizer, Roche.

EFFICACY AND SAFETY OF TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS IN REAL CLINICAL PRACTICE

2020 ◽  
Vol 58 (3) ◽  
pp. 268-275
Author(s):  
E. Yu. Loginova ◽  
Yu. L. Korsakova ◽  
E. E. Gubar ◽  
P. L. Karpova ◽  
T. V. Korotaeva
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Clinical Manifestations ◽  
Activity Score ◽  
Tender Joint Count ◽  
Efficacy And Safety ◽  
Low Disease Activity ◽  
Number Of Patients

Objective: to evaluate the clinical efficacy and safety of the targeted synthetic disease-modifying anti-rheumatic drug (DMARD) tofacitinib (TOFA; Yakvinus®) in patients with active psoriatic arthritis (PsA) at 12 and 24 weeks after starting treatment. To define the place of TOFA in the therapy of PsA patients. Subjects and methods. Examinations were made in 41 patients (17 men and 24 women) with active PsA and an insufficient response to previous treatment with synthetic DMARDs and/or biological agents (BA). Before starting therapy, the median disease activity for psoriatic arthritis (DAPSA) and disease activity score (DAS28) were 44.2 [37.8; 55.3] and 5.5 [4.7; 6.1], respectively. TOFA tablets were prescribed at a dose of 5 mg twice daily for 24 weeks with possible dose escalation to 10 mg twice daily after 12 weeks. At the beginning of the investigation, at 12 and 24 weeks, the investigators assessed disease activity and TOFA therapy efficiency of according to DAPSA, DAS28 and minimal disease activity (MDA) criteria: tender joint count ≤1, swollen joint count ≤1, a psoriasis area severity index (PASI) ≤1 or body surface area (BSA) ≤3%, pain intensity ≤15 mm, patient global assessment ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, and enthesitis ≤1. They also determined the number of patients who had achieved remission (DAPSA ≤4, DAS28 score <2.6), low disease activity (DAPSA 5-14, ≤2.6, DAS28 <3.2) or MDA (5 out of the 7 criteria) during TOFA therapy at 24-week follow-up. The safety of therapy was evaluated by analyzing the drug-induced adverse events (AE): the frequency, severity and time of their occurrence were studied. Results and discussion. At 24 weeks after initiation of TOFA therapy, there was a significant decrease of median DAPSA and DAS28 values as compared to baseline, to 11 [4.3; 17.3] and 2.6 [1.7; 3.4] respectively. The median Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) also significantly decreased from 6 [4.2; 7] and 3.8 [2.8; 4.4] to 1.4 [0.6; 3.2] and 1.5 [1; 2.1] respectively. The median BSA was significantly reduced from 3 [1; 5] to 0.5 [0.1; 2]. At 24 weeks after initiation of TOFA therapy, DAPSA and DAS28 low disease activity/remission were achieved by 38.5/23.1% and 17.9/53.9% of patients, respectively. Fifteen (38.5%) patients achieved MDA. 38 (92.7%) of the 41 patients completed a full TOFA therapy cycle. Two patients dropped out of the investigation due to ineffective therapy and one due to AE (diarrhea occurring up to 10 times daily, headache, elevated blood pressure, and lacrimation). At 24 weeks, 14 (34.2%) patients reported to have AE. The most common AE noted in 7 (17.1%) patients were infections: acute respiratory viral infection (n=3), fever (n=2), and folliculitis (n=2). In addition, two patients had diarrhea and two had headache. Conclusion. TOFA is an effective drug for the treatment of PsA patients with moderate or high inflammatory activity, has a significant effect on all clinical manifestations of PsA and has a satisfactory safety profile.

The Uses of Disease Activity Scoring and the Physician Global Assessment of Disease Activity for Managing Rheumatoid Arthritis in Rheumatology Practice

2009 ◽  
Vol 36 (5) ◽  
pp. 925-929 ◽  
Author(s):  
J. TIMOTHY HARRINGTON
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Office Visit ◽  
Inactive Disease ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Soft Tissue Rheumatism ◽  
Assessment Of Disease Activity ◽  
Rheumatology Practice

Objective.To evaluate the uses of quantitative disease activity scoring and a physician global assessment of disease activity for managing rheumatoid arthritis (RA) in rheumatology practice.Methods.The Global Arthritis Score (GAS) and a physician global assessment (Physician Global) were determined during each office visit for a community practice RA population. The GAS was calculated from patients’ self-reported pain, functional assessment, and tender joint count. The Physician Global was recorded on a 10-point visual analog scale. The correlation of these 2 disease activity measures was determined for the most recent office visit of 185 patients with RA, and the reasons for discordant results were identified by chart review.Results.The GAS and Physician Global were concordant for active or inactive disease in 126 of 185 patients (68%) and were discordant in 59 (32%). Forty-five of these discordant patients had a high GAS while their Physician Global indicated inactive disease. Their GAS values were high because of osteoarthritis, back pain, soft tissue rheumatism, and/or prior joint damage rather than active RA. The other 14 patients had a low GAS with an uncontrolled Physician Global for a variety of reasons.Conclusion.(1) An RA disease activity score and a quantitative Physician Global can be measured during rheumatology office visits to document patients’ disease status. (2) Disease activity scoring contributes valuable information, but should not replace the Physician Global in guiding RA patient management or reimbursement decisions.

scholarly journals Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE

2020 ◽  
Vol 7 (4) ◽  
pp. 851-866 ◽  
Author(s):  
Yue Yang ◽  
Xing-Fu Li ◽  
Xiao Zhang ◽  
Chun-De Bao ◽  
Jian-Kang Hu ◽  
...  
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Activity Index ◽  
Disease Activity Index ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Acr20 Response ◽  
Subgroup Analyses ◽  
Baseline Characteristics ◽  
Assessment Of Disease Activity

Abstract Introduction Baricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, which has demonstrated significant efficacy in patients with moderately to severely active rheumatoid arthritis (RA). This analysis aims to describe the efficacy and safety of baricitinib in Chinese RA patients with an inadequate response to methotrexate (MTX-IR), and to analyze the effects of baseline characteristics on the efficacy of baricitinib treatment. Methods In this 52-week, randomized, double-blind, placebo-controlled study, 231 Chinese patients with moderately to severely active RA who had MTX-IR were randomly assigned to placebo (n = 115) or baricitinib 4 mg once daily (n = 116). The primary endpoint was American College of Rheumatology 20% (ACR20) response at week 12. Other efficacy measures included ACR50, ACR70, Physician’s Global Assessment of Disease Activity, Patient’s Global Assessment of Disease Activity, patient’s assessment of pain, Disease Activity Score in 28 joints using high-sensitivity C-reactive protein, remission and low disease activity rates according to Simplified Disease Activity Index or Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, and mean duration and severity of morning joint stiffness, worst tiredness and worst joint pain were analyzed. Additionally, subgroup analyses were performed across baseline characteristics. Results Statistically significant improvement in ACR20 response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo. Most of the secondary objectives were met with statistically significant improvements. Efficacy of baricitinib was irrespective of patient demographics and baseline characteristics. Safety events were similar between the baricitinib and placebo groups. Conclusions The efficacy of baricitinib 4 mg in Chinese patients with moderately to severely active RA and prior MTX-IR was clinically significant compared to placebo regardless of baseline characteristics. Baricitinib was well tolerated with an acceptable safety profile during the full study period. Trial Registration NCT02265705

scholarly journals AB0817 DOES SMOKING AFFECT SECUKINUMAB TREATMENT OUTCOMES AND SAFETY IN PATIENTS WITH PSORIATIC ARTHRITIS? - REAL WORLD DATA FROM THE GERMAN AQUILA STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1711.1-1711
Author(s):  
E. Riechers ◽  
U. Kiltz ◽  
J. Brandt-Juergens ◽  
P. Kästner ◽  
D. Peterlik ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Interim Analysis ◽  
Smoking Status ◽  
Depressive Mood ◽  
Research Support ◽  
Real World Data ◽  
World Data ◽  
Number Of Patients

Background:Several studies have shown a negative association between smoking status and psoriatic arthritis (PsA) clinical outcomes.1,2The German non-interventional study AQUILA provides real-world data on the influence of smoking on therapeutic effectiveness and safety issues under secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin-17A.Objectives:The aim of this interim analysis is to describe selected baseline (BL) demographics, to evaluate SEC effectiveness on disease activity and depressive mood and to report the safety profile depending on smoking status of PsA patients.Methods:AQUILA is an ongoing, multi-center study including up to 2700 patients with active PsA or ankylosing spondylitis. Patients were observed from BL up to week (w) 52. Real-world data was assessed prospectively and analyzed as observed. In addition to the assessment of C-reactive protein (CRP), data was collected on patient´s disease activity (tender/swollen joint counts, TJC/SJC), skin disease activity (Psoriasis Area and Severity Index, PASI) and depressive mood (Beck´s Depression Inventory version II, BDI-II). For calculation of the proportion of patients who experienced (serious) adverse events ((S)AEs), all PsA patients were included who received at least one dose of SEC irrespective of further documentation of any study visit. This interim analysis focuses on subgroups non-smoker (NS) and smoker (S).Results:At BL, 641 PsA patients were included: 49.8% (n=319) non-smokers (NS) and 24.3% (n=156) smokers (S). 17.5% (n=112) were ex-smoker and 8.4% (n=54) of unknown smoking status. In both, NS and S, the proportion of women was higher (58.0% in NS and 67.3% in S). NS were slightly older than S (mean age: 53.8/49.7 years). There were no significant differences between NS and S in mean CRP within the 52 weeks (Fig. 1A). Both TJC and SJC improved over time and were similar between NS and S (Fig. 1B). Although mean absolute PASI value was worse in S at BL, a similar temporal improvement was seen in both groups (NS: 7.0 at BL to 1.0 at w52; S: 9.2 at BL to 1.0 at w52). BDI-II scores decreased in both groups with overall higher values in S (NS: 10.9 at BL to 9.1 at w52; S: 12.8 at BL and 10.8 at w52). Regarding the occurrence of AEs and SAEs with or without suspected relationship to SEC, NS had percentagewise less events than S (Table 1). In addition, percentage of PsA patients who discontinued SEC treatment due to an AE was lower for NS compared to S.Table 1.Overview of AEs (and SAEs) under SEC treatment depending on smoking status in PsA patientsNumber of patients withNS (N=333), n (%)S (N=161),n (%)P valueAE233 (70.0)118 (73.3)0.11AE with suspected relationship to SEC129 (38.7)72 (44.7)0.10SAE74 (22.2)45 (28.0)0.06SAE with suspected relationship to SEC29 (8.7)18 (11.2)0.37Figure 1.Disease activity in PsA patients treated with SEC depending on the smoking status**CRP data/ACR joint counts were documented not for all PsA patients at BL and subsequent visits.Conclusion:In a real-world setting, SEC improved disease activity and depressive mood of PsA patients with no obvious differences between NS and S. Overall, this interim analysis shows that SEC is an effective and reliable treatment, irrespective of the PsA patients’ smoking status. Further progress of the AQUILA study as well as long-term data from other real-world observational studies with SEC, such as SERENA, will reveal whether this trend will continue.References:[1]Hojgaard P et al, Ann Rheum Dis 2015; 74:2130-6; 2. Eder L et al, Arthritis Care Res 2011 Aug; 63:1091-7Disclosure of Interests:Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

scholarly journals Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Health Assessment ◽  
Severity Index ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Minimal Disease Activity ◽  
Tender Joint ◽  
Minimal Disease

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.

scholarly journals SAT0434 MINIMAL CLINICALLY IMPORTANT DIFFERENCE IN OUTCOME MEASURES FOR USE IN CLINICAL CARE AND PRAGMATIC TRIALS IN PsA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1173.1-1174
Author(s):  
A. Ogdie ◽  
M. E. Husni ◽  
J. Scher ◽  
E. Craig ◽  
S. Reddy ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Outcome Measures ◽  
Global Assessment ◽  
Outcome Measure ◽  
Pragmatic Trials ◽  
Research Support ◽  
Patient Reported ◽  
The Mean

Background:While several outcome measures have been studied for use in clinical studies of psoriatic arthritis, little is known about thresholds of meaning such as minimal clinically important improvement (MCII).Objectives:To investigate the distribution of scores for candidate outcome measures for pragmatic trials in PsA and to calculate the MCII for each outcome measure.Methods:We performed a longitudinal cohort study within the Psoriatic Arthritis Research Consortium (PARC), a multi-center study based in the US. Patients completed validated PROs (patient reported outcomes) and rheumatologists completed skin, joint, enthesis and dactylitis scores at therapy initiation and follow up 12-16 weeks later. In addition, patients completed a global assessment of response at the follow up visit, categorizing their status as improved, stayed the same, or worsened and then ratied the importance of the change on a scale from 0-7.1We then calculated and plotted the change in each of the following measures: Routine Assessment of Patient Index Data (RAPID3), clinical Disease Activity of Psoriatic Arthritis (cDAPSA), Patient Reported Outcome Measure Information System (PROMIS) Global Health short form (10a) physical health (PH) subscore, patient pain assessment, patient global assessment (0-10 NRS), and physician global assessments (0-10 NRS) of the joints and overall. We calculated the MCII as the mean change in score (with 95% confidence interval) among patients who reported improvement and rated the level of improvement as “almost none/hardly at all” or “a little important.” Additionally, we calculated Spearman’s correlation coefficients between the measures and the global assessment of response.Results:Among 148 unique patients, 233 therapy change visits were eligible for analysis. The average age was 52.5 years, 52% were female and mean BMI was 29.6. Baseline RAPID3 was 11.1 (SD 6), cDAPSA 17.9 (SD 13.9), PROMIS PH 42 (SD 8), patient global 4.2 (SD 2.5), TJC 5.9 (SD 7.5), and SJC 2.9 (SD 4.5). TNFi comprised 61% of drug initiations, 21% were IL17i and the remainder were other biologics and oral systemic therapies. At follow up, 63 (27%) patients rated themselves as improved whereas 103 (44%) stayed the same and 67 (29%) reported worsening. The mean change in each measure by patient-reported response (improved, stayed the same, or worsened) are shown in Figures 1A & B. In general, the mean score increased from ‘improved’ to ‘worsened’ as expected (with the exception of PROMIS PH which declines given a different direction of scoring). The MCII for each measure was as follows: RAPID3 -1.8 (-4.1 to 0.5), Patient Global -0.6 (-1.6 to 0.4), Physician Global -1 (-1.9 to -0.1), cDAPSA -5.7 (-9.8 to -1.7), and PROMIS PH 1.9 (-2.1 to 5.8). Correlation for each measure with the global assessment of response were: RAPID3 0.48, Patient Global 0.37, Physician Global 0.39, cDAPSA 0.51, and PROMIS PH 0.39.Figure 1A. Distribution of change (median, IQR) in RAPID3, Physician Global, Patient Global, PROMIS10a physical therapy by patient reported response.Conclusion:This is the first study to test thresholds of meaning for these particular measures in PsA. The MCII values are relatively low for all outcome measures. This may be related to the relatively low disease activity at baseline but is consistent with patients seen in clinical practice initiating therapy.2References:[1]Ward MM et al. J Clinical Epi 2014;2Ward MM et al. J Clinical Epi 2015Figure 2B. Distribution of change (median, IQR) in clinical DAPSA by patient reported response.Disclosure of Interests:Alexis Ogdie Grant/research support from: Pfizer, Novartis, Consultant of: Abbvie, Amgen, BMS, Celgene, Corrona, Janssen, Lilly, Pfizer, Novartis, M Elaine Husni Grant/research support from: Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Regeneron, and UCB, Jose Scher Consultant of: Novartis, Janssen, UCB, Sanofi., Ethan Craig: None declared, Soumya Reddy Grant/research support from: AmgenCelgeneAbbvie, Consultant of: AmgenPfizerNovartisJaansenUCB, Jessica A. Walsh Grant/research support from: AbbVie, Pfizer, Janssen, Consultant of: AbbVie, Novartis, Eli Lilly and Company, UCB

scholarly journals SAT0411 EFFICACY AND SAFETY OF IXEKIZUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS AND INADEQUATE RESPONSE TO TNF INHIBITORS: THREE YEAR RESULTS FROM A PHASE 3 STUDY (SPIRIT-P2)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1158.1-1158
Author(s):  
J. Gratacos-Masmitja ◽  
A. Turkiewicz ◽  
E. Dokoupilova ◽  
A. M. Gellett ◽  
A. T. Sprabery ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Outcome Measures ◽  
Signs And Symptoms ◽  
Severity Index ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Research Support ◽  
Intent To Treat

Background:Ixekizumab (IXE) is a high affinity monoclonal antibody that selectively targets interleukin-17A. In the SPIRIT-P2 study, IXE every 4 (Q4W) or 2 (Q2W) weeks was superior to placebo (PBO) in improving the signs and symptoms of psoriatic arthritis (PsA) at Week 24 in patients (pts) with prior inadequate response or intolerance to 1 or 2 tumor necrosis factor inhibitors (TNFi).Objectives:To determine efficacy and safety of IXE treatment up to 3 years in pts with PsA.Methods:In SPIRIT-P2 (NCT02349295), 310 pts entered the extension period where pts maintained their original ixekizumab dose, and placebo pts received IXEQ4W or IXEQ2W (1:1). Pts failing to demonstrate ≥20% improvement in both tender and swollen joint counts at Week 32, or any subsequent visit, were discontinued (mandatory discontinuation criteria). Efficacy outcomes were ACR20/50/70 response, Psoriasis Area and Severity Index (PASI) 75/90/100 response, Leeds Enthesitis Index (LEI), Leeds Dactylitis Index-Basic (LDI-B), Minimal Disease Activity (MDA), and Disease Activity in Psoriatic Arthritis (DAPSA). Ad-hoc efficacy data are presented for intent-to-treat (ITT) pts initially randomized to IXE at Week 0. Observed and modified non-responder imputation (mNRI; missing data treated as non-response for pts discontinued due to lack of efficacy or adverse events [AEs]) was applied to categorical measures. Observed and modified baseline observation carried forward (mBOCF) was applied to continuous efficacy measures. Safety was analysed in pts exposed to at least one dose of IXE.Results:Of the 245 pts initially randomized to IXE at Week 0 (ITT), 64 (26.1%) pts discontinued due to lack of efficacy and 22 (9.0%) pts due to mandatory discontinuation criteria. Efficacy results are summarized below (Figure 1). Pts in SPIRIT-P2 who received IXEQ4W and IXEQ2W for 156 weeks reported sustained improvement in ACR responses and manifestations of PsA, including enthesitis, dactylitis, and skin outcomes. Treat-to-target measures such as MDA and DAPSA (Low Disease Activity or Remission) were achieved by 30.8% and 47.7% of pts, respectively on IXEQ4W, and by 29.2% and 40.7% of pts, respectively on IXEQ2W. Incidence rates (IR) of treatment-emergent adverse events (TEAEs) are provided below (Figure 2). Most TEAEs were mild or moderate in severity, and 38 out of 337 (5.9%) pts (safety population) discontinued due to AEs. The most common TEAEs were infections (IR=33.1) and injection site reactions (IR=5.4). Three deaths were reported in the study.Figure 1.Efficacy Outcome Measures at Week 156 (Intent-to-treat Population).ACR=American College of Rheumatology; IXE=ixekizumab; LEI=Leeds Enthesitis Index; LDI-B=Leeds Dactylitis Index-Basic; mNRI=modified non-responder imputation; PASI=Psoriasis Area and Severity Index; Q2W=every two weeks; Q4W=every four weeks.Figure 2.Safety Outcome Measures (Weeks 0-156).Safety was analysed in patients exposed to at least one dose of ixekizumab. During the double-blind treatment period (Weeks 0-24), one patient reported serious adverse events of anal fistula and anal abscess, which were considered by the sponsor to be IBD; however, an independent adjudication committee of external experts reviewed the case and determined the events to be “Not IBD.”Conclusion:In pts treated with IXE who had prior inadequate response or intolerance to 1 or 2 TNFi, improvements in the signs and symptoms of PsA persisted up to 3 years. No unexpected safety signals were observed, and the safety profile was consistent with previous studies of IXE.Disclosure of Interests:Jordi Gratacos-Masmitja Grant/research support from: a grant from Pfizzer to study implementation of multidisciplinary units to manage PSA in SPAIN, Consultant of: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Speakers bureau: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Anthony Turkiewicz Grant/research support from: Received research grants from AbbVie, Eli Lilly and Company, Janssen, Novartis, and Pfizer, Consultant of: Received consulting fees from AbbVie, Eli Lilly and Company, Janssen, Novartis, and Pfizer, Speakers bureau: On speaker bureau for Abbvie, Eli Lilly and Company, Janssen, Novartis, Pfizer, Eva Dokoupilova Grant/research support from: Eli Lilly, AbbVie, Novartis, Amanda M. Gellett Shareholder of: Eli Lilly and company, Employee of: Eli Lilly and company, Aubrey Trevelin Sprabery Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir J. Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB

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