AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

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AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5263 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1463.2-1464

Author(s):

S. Bayat ◽

K. Tascilar ◽

V. Kaufmann ◽

A. Kleyer ◽

D. Simon ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Cox Regression ◽

Real Life ◽

Inadequate Response ◽

Research Support ◽

Das 28 ◽

Patient Reported ◽

One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

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FRI0273 EFFECTIVENESS AND RETENTION RATE OF SECUKINUMAB FOR PSORIATIC ARTHRITIS AND AXIAL SPONDYLOARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN LORHEN REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3197 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 722.1-723

Author(s):

E. G. Favalli ◽

A. Marchesoni ◽

S. Balduzzi ◽

C. Montecucco ◽

C. Lomater ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Disease Duration ◽

Axial Spondyloarthritis ◽

Retention Rate ◽

Real Life ◽

Advisory Board ◽

Inactive Disease ◽

Real Life Setting

Background:Observational data on the use of secukinumab for the treatment of spondyloarthritides are still lacking. Large population-based registries that allow long-term follow-up have been increasingly used to investigate the performance of biologic drugs in a real life setting.Objectives:The aim of this study is to evaluate the effectiveness and the retention rate of secukinumab in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients in a real-life setting over a 3-year follow-up period.Methods:Data of all PsA and axSpA patients (diagnosed according to CASPAR and ASAS criteria, respectively) treated with secukinumab were prospectively collected in the Italian multicentric LORHEN registry. Effectiveness was measured as the mean change from baseline of Disease Activity in PSoriatic Arthritis score (DAPSA) in PsA and Ankylosing Spondylitis Disease Activity Score (ASDAS) in axSpA patients. Rates of DAPSA remission and ASDAS inactive disease were also computed. The 3-year retention rate was calculated by the Kaplan-Meier method and compared between PsA and axSpA by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 195 PsA (55.4% females, mean age 50.7 [±11.8] years, mean disease duration 10 [±7.8] years, mean baseline DAPSA 23.12 [±12.3]) and 94 axSpA (61.7% males, mean age 49.1 [±12.7] years, mean disease duration 10.4 [±9.4] years, mean baseline ASDAS 3.41 [±1.1]) patients who received secukinumab as first (26.5 and 33%, respectively) or subsequent biologic agent. Compared with baseline, the 3-, 6- and 12-month mean values of both DAPSA (12.6 [±9], 11.2 [±10.5] and 9.3 [±7.5], respectively) and ASDAS (2.23 [±0.9], 2.15 [±0.9], and 1.84 [±0.9], respectively) were significantly decreased (p<0.001 for all the timepoints). The 3-, 6-, and 12-month rates of remission/inactive disease were 15.5, 25.4, and 30.5% in PsA and 18, 23.7, and 28.6% in axSpA group, respectively. One- and 3-year retention rate (figure 1) were respectively 79.4% and 66.6% in PsA and 72.3% and 70.1% in axSpA patients, with no significant difference between the two groups (p=0.517). The most frequent reason for withdrawal was inefficacy in both PsA (n=41) and axSpA (n=20), whereas only 8 PsA and 6 axSpA patients discontinued secukinumab because of adverse events.Conclusion:Our data confirmed in a real-life setting the 1-year clinical efficacy and the 3-year survival of secukinumab in both PsA and axSpA. The safety profile of secukinumab was very favorable for both the indications. No significant differences were observed in the performance of secukinumab between ax-SpA and PsA.References:[1]Deodhar A, et al. Arthritis Research & Therapy; 2019.[2]Mease PJ, et al. RMD Open. BMJ Specialist Journals; 2018;4(2):e000723.[3]Baraliakos X, et al. Clin Exp Rheumatol. 2018 Jan;36(1):50–5.Disclosure of Interests:Ennio Giulio Favalli Consultant of: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Speakers bureau: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Antonio Marchesoni Speakers bureau: Abbvie, Pfizer, UCB, Novartis, Celgene, Eli Lilly, Silvia Balduzzi: None declared, Carlomaurizio Montecucco: None declared, Claudia Lomater Consultant of: Advisory board for Sanofi, Novartis, Abbvie, Gloria Crepaldi Consultant of: Advisory board for Sanofi and Celgene, Speakers bureau: BMS, MSD, Silvia Talamini: None declared, Chiara Bazzani: None declared, Enrico Fusaro: None declared, Marta Priora: None declared, Aurora Iannello: None declared, Giuseppe Paolazzi: None declared, Roberto Caporali Consultant of: AbbVie; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme; Celgene; Bristol-Myers Squibb; Pfizer; UCB, Speakers bureau: Abbvie; Bristol-Myers Squibb; Celgene; Lilly; Gilead Sciences, Inc; MSD; Pfizer; Roche; UCB

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3321 ◽

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

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POS0927 EFFECTIVENESS AND SAFETY OF SECUKINUMAB IN NAïVE OR TNF-INHIBITORS FAILURE AXIAL SPONDYLOARTHRITIS PATIENTS IN REAL LIFE: A 24-MONTHS PROSPECTIVE MULTICENTRIC STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2121 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 726.1-726

Author(s):

M. Lorenzin ◽

A. Ortolan ◽

M. S. Chimenti ◽

A. Marchesoni ◽

E. Lubrano ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Axial Spondyloarthritis ◽

Real Life ◽

X Rays ◽

Research Support ◽

Group A ◽

Group B ◽

Activity Indices

Background:Axial Spondyloarthritis (axSpA) can be distinguished in radiographic axSpA (r-axSpA) and non-radiographic (nr-axSpA). Secukinumab (SEC) is a novel treatment for axSpA, but data from real-life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of axSpA patients on SEC followed in 8 Italian Rheumatologic centers for 24-months;2)to compare the features and disease-activity indices of SEC-treated axSpA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors failure patients (group B).Methods:Consecutive patients with active axSpA (diagnosis according Assessment of SpondyloArthritis International Society ASAS criteria), who started SEC treatment, were evaluated prospectively.Data on disease characteristics, previous/ongoing treatments and imaging were collected. Disease-activity/functional/clinical scores and biochemical values were recorded at baseline (T0), at 6 (T6), 12 (T12), and 24 (T24) months. Effectiveness was evaluated over-time with descriptive statistics. Anova (Kruskal Wallis) and generalized linear models were used to compare variables over-time. Infections,adverse events were collected.Results:One-hundred-seven patients [49.53% men; median age 49years; median treatment duration 18.5years] were enrolled;53(49.53%) had HLA-B27, 47.66% were r-axSpA and 52.34% nr-axSpA. Signs of sacroiliitis were present on MRI in 97 (90.65%) and X-rays in 51 (47.66%). SEC was prescribed as first line biologic treatment in 32 (29.9%) patients and as second or more line biological treatment in 75 (70.1%) patients (Figure 1). In all population significant decrease was achieved in:Visual Analogue Scale of pain and general-health; Leeds Enthesitis Index;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-s);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein. Bath Ankylosing Spondylitis Metrology Index and Erythrocyte-sedimentation-rate not significantly decreased. Effectiveness was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [T0=3.4 (2.9-3.9) vs T24=1.9 (1.2-2.7);p=0.02] and in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [T0=6.6 (5.0-7.8) vs T24=3.2 (2.0-5.0);p=0.03].At T0 group B had a longer disease duration (p=0.04),a greater prevalence of peripheral arthritis (p=0.02),enthesitis (p=0.04) and psoriasis (p=0.05) and was mostly male (p=0.05),while no significant difference was observed for functional and disease-activity indices and signs of sacroiliitis on MRI/X-rays. At T24 group A showed better physical functioning and lower disease activity compared to group B [HAQs A vs. B=0.1(0.0-0.5) vs 0.3(0.1-0.8); BASFI A vs B=1.6(0.8-4.8) vs 4.0(2.5-4.6); BASDAI A vs B=2.2(1.0-3.8) vs 3.9(2.7-5.0);ASDAS A vs B=1.3(1.0-2.2) vs 2.1(1.6-2.9)].After T24 of treatment 70.2% of Group A and 68.4% of Group B had a low disease activity,accordingly to ASDAS<2.1. Twenty-three patients (21.5%) stopped the treatment during the follow-up mainly because of primary (7) or secondary loss of efficacy (9).Only 7 patients suspended SEC because of adverse events.A low number of episodes of mild infections (19) occurred;SEC was instead permanently discontinued in 4 cases for:oral refractory mucositis (2);recurrent aphthosis (1);recurrent broncopneumoniae (1).The retention rate at t24 was good in the whole population (73%).Survival curves for Group A and B were similar (log-rank test=0.81;p=0.69).Conclusion:In a real-life clinical setting,SEC was safe and effective in axSpA, as shown by a significant decrease of BASDAI and ASDAS over a 24-months follow-up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Augusta Ortolan: None declared, Maria Sole Chimenti: None declared, Antonio Marchesoni Grant/research support from: AM has received honoraria and speaker fees from Abbvie, Pfizer, MSD, UCB, Novartis, Janssen, Eli-Lilly., Ennio Lubrano: None declared, Leonardo Santo Speakers bureau: Speaker from Jansen, Novartis, Pfizer, UCB, MSD, Sanofi, Angelo Semeraro: None declared, Carlo Salvarani: None declared, Nicolò Girolimetto: None declared, Emanuela Praino: None declared, Giulia Lavinia Fonti: None declared, Rosario Foti: None declared, Antonio Carletto: None declared, Andrea Doria Grant/research support from: ADhas received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen., Roberta Ramonda Grant/research support from: RR has received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen.

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AB0774 TIME TO RESPONSE FOR CLINICAL AND PATIENT-REPORTED OUTCOMES IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH TOFACITINIB, ADALIMUMAB OR PLACEBO

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.994 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1685.2-1685

Author(s):

D. D. Gladman ◽

L. C. Coates ◽

J. Wu ◽

L. Fallon ◽

M. A. Hsu ◽

...

Keyword(s):

Disease Activity ◽

Kinase Inhibitor ◽

Initial Response ◽

Analysis Data ◽

Janus Kinase ◽

Research Support ◽

Two Phase ◽

Treatment Groups ◽

Link Type ◽

Patient Reported

Background:With multiple disease domains affected in PsA, clinical and patient-reported outcome (PRO) measures are important to assess disease improvement following treatment. Rapid, meaningful improvements in disease activity are a priority for physicians and patients (pts). Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. Higher proportions of pts achieved responses in PROs and clinical measures when treated with tofacitinib for 3 months vs placebo (PBO).1-5Proportions of responders were also similar between tofacitinib and adalimumab (ADA) after 3, 6 and 12 months.2,3,5Objectives:To determine the time to initial response using responder definitions for selected PROs and clinical endpoints in pts with active PsA treated with tofacitinib, ADA or PBO switching to tofacitinib.Methods:In this post hoc analysis, data were collected from two Phase 3 studies (OPAL Broaden [12 months;NCT01877668]; OPAL Beyond [6 months;NCT01882439]).3,4Pts receiving tofacitinib 5 or 10 mg twice daily (BID), subcutaneous ADA 40 mg once every two weeks (Q2W; OPAL Broaden only), or PBO switching to tofacitinib 5 or 10 mg BID at Month (M)3, were included. Responder definitions included: HAQ-DI ≥0.35-point improvement from baseline (BL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score ≥4-point improvement from BL, minimal disease activity (MDA) yes/no composite response (meeting at least 5 of 7 criteria) and PsA Disease Activity Score (PASDAS) post-BL score of ≤3.2 and >1.6-point improvement from BL. First post-BL data were collected at Week 2 (eg for HAQ-DI) or M1. Time-to-event analyses were performed using the Kaplan-Meier (KM) method, with pts censored at the last observed visit. Log-rank tests compared time to initial response across treatment groups.Results:KM analyses show days to initial response (Figure 1, Figure 2). Time to initial HAQ-DI response was significantly different between treatment groups in OPAL Broaden (p<0.01): faster response in pts receiving tofacitinib 5 mg BID, tofacitinib 10 mg BID and ADA 40 mg Q2W vs pts who switched from PBO to tofacitinib at M3 (Figure 1a). A similar, but not significant (ns), trend was observed for HAQ-DI responses in OPAL Beyond (Figure 1b). Generally, initial FACIT-F responses were achieved faster (ns) in pts receiving tofacitinib 5 mg BID vs other treatment in both studies (Figure 1c, Figure 1d). Times to initial MDA and PASDAS responses were similar between tofacitinib and ADA treatment groups (Figure 2).Conclusion:Times to initial response in functional ability and disease activity were similar in pts treated with either tofacitinib or ADA. Time to initial response prior to first post-BL observation (Week 2 or M1) was not estimable in this analysis. These results may help physicians better understand the time frame for a meaningful response in pts receiving tofacitinib.References:[1]Strand et al. RMD Open 2019;5:e000808.[2]Strand et al. RMD Open 2019;5:e000806.[3]Mease et al. NEJM 2017;377:1537-50.[4]Gladman et al. NEJM 2017;377:1525-36.[5]Helliwell et al. Arthritis Res Ther 2018;20:242.Acknowledgments:Study sponsored by Pfizer Inc. Medical writing support was provided by Eric Comeau of CMC Connect and funded by Pfizer Inc.Disclosure of Interests:Dafna D Gladman Grant/research support from: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – consultant, Laura C Coates: None declared, Joseph Wu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lara Fallon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Ming-Ann Hsu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Andrew G Bushmakin Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Elizabeth Bacci Employee of: Evidera, Joseph C Cappelleri Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Philip Helliwell: None declared

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P289 A French nationwide prospective study on patients with Crohn’s disease and ulcerative colitis treated with Infliximab-biosimilar CT-P13 in a real-life setting: two-year follow-up of the ReFLECT study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.413 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S320-S321

Author(s):

Y Bouhnik ◽

S Nancey ◽

M Assing ◽

N Mammar ◽

D Laharie

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Disease Activity ◽

Safety Data ◽

Real Life ◽

Life Study ◽

Mayo Score ◽

Real Life Setting

Abstract Background ReFLECT study was carried out to investigate real-life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator. Methods This multicentre, prospective, observational study was conducted in France to assess characteristics of patients (pts) receiving CT-P13, its effectiveness and safety in a real-life setting. Eligible were both pts who had been switched from IFX originator (IFXS) and IFX-naïve pts started on CT-P13 (IFXN). These interim descriptive statistical analyses are about pts with Crohn’s disease (CD) and ulcerative colitis (UC). Results Among the 1370 adult pts included between October 2016 and April 2019, data were analysed for 508 CD pts (48.6% males; mean age ± SD: 37.7±13.7; median [Q1;Q3] disease duration: 6.2 [1.9;13.7] years; 323 IFXN/145 IFXS) and 213 UC pts (54%; 42.9±17.2; 5.4 [1.6;12.8]; 154 IFXN/46 IFXS). Previous biologics other than IFX were taken by 32.9% of CD and 39.0% of UC pts; 31% (CDS) and 23% (UCS) of pts were switched from IFX originator to CT-P13. At the time of the first administration of CT-P13, disease had been more active in IFXN vs IFXS pts: 52.9% vs 13.3% in CD with a median [Q1;Q3] Harvey Bradshaw Index (HBI) of 4 [1;8] vs 1 [0;2] and, 82.9% vs 33.3% in UC with a median Mayo Score of 7 [3;10] vs 2 [0;4]. In IFXS pts, disease activity remained stable after 2 years of treatment with median differences of HBI and Mayo score since first administration of 1 [0;2] and 0 [-4;1]. In IFXN pts, median differences of HBI and Mayo score since first administration were -2 [-7;1] and -7 [-8;-5]; CT-P13 brought disease activity down to levels below or comparable to those seen in IFXS pts. Reasons for CT-P13 withdrawing and safety data are reported in Tables 1 and 2. Conclusion Year 2 follow-up data indicate that CT-P13 effectively induced improvement in disease activity in IFXN pts with CD or UC and maintained stable activity in IFXS pts. This real-life study did not highlight any new safety concerns.

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Efficacy and safety of long-acting pasireotide in acromegalic patients in the real life: The reappraisal of the first-dose follow-up visit

Endocrine Abstracts ◽

10.1530/endoabs.70.aep1065 ◽

2020 ◽

Author(s):

Claudio Urbani ◽

Francesca Dassie ◽

Benedetta Zampetti ◽

Di Certo Agostino Maria ◽

Renato Cozzi ◽

...

Keyword(s):

Real Life ◽

Efficacy And Safety ◽

The Real ◽

Long Acting

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POS0693 EFFICACY AND SAFETY OF BELIMUMAB IN PATIENTS WITH LUPUS NEPHRITIS IN REAL-LIFE SETTING: RESULTS FROM A LARGE, NATIONWIDE, MULTICENTRIC, PROSPECTIVE COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1757 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 594-595

Author(s):

F. Saccon ◽

M. Gatto ◽

M. Zen ◽

M. Fredi ◽

F. Regola ◽

...

Keyword(s):

Lupus Erythematosus ◽

Independent Predictor ◽

Rescue Therapy ◽

Real Life ◽

Multivariate Logistic Regression Analysis ◽

Class Iii ◽

Baseline Serum ◽

Renal Response ◽

Real Life Setting

Background:LN is still a severe manifestation of Systemic lupus erythematosus (SLE) and multitarget therapy is needed to control the disease especially in refractory cases.Objectives:To evaluate renal response in SLE patients with glomerulonephritis (GN) treated with Belimumab in real-life setting.Methods:Patients with proteinuria >0.5 g/24 h and/or active sediment at baseline enrolled in a multicentre Italian cohort of SLE patients (BeRLiSS study), treated with monthly iv Belimumab 10 mg/kg plus standard of care were considered in this study. Complete renal response (CRR) was defined as proteinuria <0.5 g/24 h, estimated glomerular filtration rate (eGFR)≥90ml/min/1.73m2 and no rescue therapy. Primary efficacy renal response (PERR) was defined as proteinuria ≤0.7 g/24 h, eGFR ≥60ml/min/1.73m2 and no rescue therapy. Prevalence and predictive factors of CRR and PERR at 12 and 24 months after Belimumab initiation were analyzed by multivariate logistic regression analysis.Results:A total of 91 patients were considered in this study, 79 female, mean age 40.51±9.03 years, mean disease duration 12.18±8.15 years, median follow-up time after Belimumab initiation 22 months. Twenty patients had baseline proteinuria ≥0.5 <1 g/day, 17 ≥1 <2 g/day, 13 ≥2 g/day. Belimumab was started at GN onset in 20 (22%) patients and at the time of a renal flare in all other cases. Seventy-five patients underwent a renal biopsy: 1 class I, 4 class II, 14 class III, 47 class IV and 9 class V. Baseline serum creatinine was 82.44±29.26 umol/L; 15 patients showed eGFR<60ml/min/1.73m2 at baseline. Immunosuppresants were taken by 70 (76.9%) patients: 47 micofenolate, 15 azathioprine and 5 ciclosporine. Sixty patients (65.9%) were on antimalarials. During follow-up 34 (37.4%) patients achieved CRR. Among them 5 (14.7%) patients relapsed and 29 (85.3%) patients maintained remission. Mean time to achieved CRR was 9.71±5.91 months.High levels of baseline proteinuria were a negative independent predictor of CRR and PERR at 6 months (OR 0.044 CI95% 0.006-0.320 p=0.002 and OR 0.232 CI95% 0.091-0.596 p=0.002) and 12 months (OR 0.029 CI95% 0.002-0.556 p=0.019 and OR 0.056 CI95% 0.009-0.327 p=0.001). High levels of baseline creatinine were a negative independent predictor of renal response. Renal response at 6 months was a strong predictive factor of renal response at 12 and 24 months.Conclusion:Belimumab is an effective add-on therapy in the treatment of GN in real-life practice setting.Disclosure of Interests:None declared

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SAT0501 EARLY START OF BIOLOGICAL TREATMENT IN JUVENILE IDIOPHATIC ARTHRITIS: DOES A THERAPEUTIC WINDOW EXIST IN REAL LIFE?

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4611 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1207.2-1207

Author(s):

A. García Fernández ◽

A. Briones-Figueroa ◽

L. Calvo Sanz ◽

Á. Andreu-Suárez ◽

J. Bachiller-Corral ◽

...

Keyword(s):

Disease Activity ◽

Biological Treatment ◽

Real Life ◽

Therapeutic Window ◽

Systemic Jia ◽

Active Arthritis ◽

The Impact ◽

Active Patients ◽

Active Disease

Background:Biological therapy (BT) has changed the treatment and perspectives of JIA patients but little is known about when is the best moment to start BT and the impact of this prompt iniciation.Objectives:To analyze the response to BT of Juvenile Idiophatic Arthritis (JIA) patients according to the time when the BT was started.Methods:A retrospective, descriptive study was conducted on JIA patients followed up in a referal hospital that started BT up to 24 months after diagnosis from 2000 to 2018. Disease activity was measured, at 2 years after diagnosis, according to Wallace criteria for remission (absence of: active arthritis, active uveitis, fever, rash or any other manifestation attributable to JIA, normal CRP and ESR, PGA indicating no active disease) for at least 6 months.Results:55 JIA patients that started BT up to 24 months from diagnosis were analyzed. 69,1% were girls with a median age at diagnosis of 8 years old IQR(3-13), median age at the start of BT of 9 years old IQR(3-13). Regarding JIA categories: 25,5% were Oligoarticular Persistent (OligP), 18,2% Systemic JIA (sJIA), 16,4% Entesitis related Arthritis (ERA), 12,7% Psoriatic Arthritis (APso) and Polyarticular RF- (PolyRF-), 5,5% Oligoarticular Extended (OligE) and Polyarticular RF+ (PolyRF+), 3,6% Undifferentiated (Und). 20% of patients had uveitis during followup. Conventional DMARD (cDMARD) was indicated in 83,6% of patients (95,7% Methotrexate) at diagnosis [median 0 months IQR(0-2,3)]. At the end of followup (2 years) only 30,9% of patients continued with cDMARDs. The main causes of discontinuation were: adverse events (46,7%), remission (36,7%). TNF inhibitors were precribed in 81,8% of patients and 18,2% of patients recieved two BT during the first 2 years from diagnosis. 54,5% of BT were indicated during the first 6 months from diagnosis, 27,3% from 7 to 12 months, 12,7% from 13 to 18 months, 5,5% from 19 to 24 months.After 2 years from diagnosis, 78,2% of patients were on remission and 21,8% active. Among patients with active disease: 75% had arthritis, 16,7% had uveitis and 8,3% had both. There were no differences regarding disease activity among patients with uveitis and neither taking cDMARDs. Regarding JIA categories: 66,7% of OligE, 57,1% of PolyRF- and 57,1% of APso patients were active at 2 years from diagnosis when compared to the other categories (p=0.004).Patients on remission at 24 months from diagnosis started sooner the BT than active patients [CI 95% (0,46-8,29) p=0,029]. The time when the BT was started was correlated to the activity at 2 years (K= 0,294 p=0,029). When the BT was prescribed after 7,5months from diagnosis it was correlated, in a COR curve, with a higher probability of active disease at 2 years (S= 0,67 E= 0,63). There was a correlation, among patients on remission at 2 years, between prompt start of BT and less time to reach remission (K= -0,345 p=0,024). Patients with active disease at 2 years, regardless of moment of BT iniciation, required more BT during follow-up (p=0,002).Conclusion:Prompt iniciation of BT was correlated with a better outcome. JIA patients that started BT early after diagnosis had a higher probability of remission after 2 years. Starting BT after 7,5 months was correlated with a higher probability of active disease at 2 years. Active disease at 24 months was correlated with persistent active disease during follow-up.Disclosure of Interests:None declared

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AB0509 SUSPENSIVE EFFICACY OF TOCILIZUMAB IN TREATMENT-NAÏVE PATIENTS WITH TAKAYASU ARTERITIS: TOCITAKA FRENCH PROSPECTIVE MULTICENTER OPEN-LABELLED TRIAL.

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4592 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1552.3-1552

Author(s):

A. Mekinian ◽

D. Saadoun ◽

J. C. N. F. [email protected] ◽

I. Q. M. F. [email protected] ◽

P. Jégo ◽

...

Keyword(s):

Disease Activity ◽

Takayasu Arteritis ◽

Immunosuppressive Drugs ◽

Relapse Free Survival ◽

Research Support ◽

Free Survival ◽

Treatment Naïve ◽

Steroid Sparing

Objectives:To assess long term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).Methods:In this multicenter, prospective, open-labelled trial, we aim to evaluate the benefit of adding tocilizumab to steroids in treatment-naïve patients with TAK, on discontinuation of steroids after 6 months of tocilizumab treatment, and to assess relapse-free survival following tocilizumab discontinuation.Results:Thirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. Among 11 (85%) patients which achieved remission at 6 months, 6 (54%) have reached primary endpoint.. Among the 5 remaining patients which continued steroids, 3 had a prednisone-equivalent dosage < 5mg/day. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3-4] at baseline, versus 1 [0-2] after 6 months; p <0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. All patients discontinued tocilizumab after 7 infusions, and no other immunosuppressive drugs was introduced, except for 1 patient which received methotrexate. After 9 and 12 months, respectively 7 (54%) and 6 (50%) patients achieved remission with less than 7.5 mg/day of prednisone, and 9 (69%) and 9 (75%) with doses <10 mg/day. During the 12 months follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.No severe AEs were considered related to study treatment and none required tocilizumab interruption or dose reduction. No deaths have occurred during the study period.Conclusion:Tocilizumab seems an effective steroid sparing therapy in TAK but its effect appears to be suspensive.Disclosure of Interests:Arsene Mekinian: None declared, david Saadoun: None declared, [email protected] [email protected]: None declared, [email protected] [email protected]: None declared, Patrick Jégo: None declared, [email protected] [email protected]: None declared, wxv wxv: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Mathieu Vautier: None declared, [email protected]>; [email protected]>;: None declared, Patrice cacoub: None declared, olivier fain: None declared

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