scholarly journals POS1301 DRUG SURVIVAL OF BIOLOGICS WITH RESPECT TO COMBINATION WITH METHOTREXATE IN TREATMENT OF POLYARTICULAR JIA

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 932.2-933
Author(s):  
G. Horneff ◽  
D. Windschall ◽  
K. Minden ◽  
T. Hospach ◽  
F. Dressler ◽  
...  
Keyword(s):  
Disease Activity ◽  
Rheumatoid Factor ◽  
Combination Treatment ◽  
Wald Test ◽  
First Line ◽  
Research Support ◽  
Biologic Treatment ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Biologic Monotherapy

Background:In polyarticular juvenile idiopathic arthritis (pJIA) biologic therapies are often combined with methotrexate (MTX). This combination was shown to increase efficacy in adult rheumatoid arthritis patients. MTX may also have a protective effect on the formation of anti-drug antibodies and thus may prolong drug survival. In pJIA, there are few and sometimes controversial data available.Objectives:To compare the effect of combination treatment with MTX on discontinuation due to inefficacy and on drug survival discontinuation of biologics approved for first line treatment of pJIA.Methods:Patients from the German BIKER registry with their first treatment course with Adalimumab, Etanercept, Golimumab or Tocilizumab were selected. Rates of ineffectiveness-related withdrawal were analysed and compared using χ2-test, Wald-test and Kaplan-Meier analysis of patients receiving biologic monotherapy or concomitant methotrexate. Cases were censored if MTX was discontinued before the biologic.Results:2173 pJIA patients were identified who for the first time received a biologic. Etanercept (ETA) was by far the most frequently used biologic for first line biologic treatment in pJIA (77%) followed by Adalimumab (ADA, 16%). Patients on Golimumab (GOL) received most frequently a combination with MTX (86.5%), while patients on Tocilizumab (TOC) had the lowest rate of combination treatment (53%).ETA/ADA/GOL/TOC was given as monotherapy in 500(30%)/89(26%)/5(13.5%)/46(47%) and combined with MTX in 1179 (70%)/259(74%)/32(86.5%)/51(53%) cases. More patients with rheumatoid-factor negative (54 vs 50%; p=0.04) and rheumatoid-factor positive pJIA (13 vs 10%, p=0.04) received combination with MTX, while more patients in the monotherapy cohort had extended oligoarthritis (40 vs 32%, p<0.001). Patients with MTX had a shorter disease duration (4 vs 5.5years, p<0.001) and received concomitant steroid more often (34 vs 24%), p<0.001). There was no statistical difference regarding disease activity parameters (active joint count, patient assessment and physician assessment of disease activity, ESR, CRP, CHAQ-DI, JADAS10). Discontinuation due to ineffectiveness was reported for ETA/ADA/GOL/TOC in 20%/18%/14%/28% of patients, respectively in 3.7/4.9/6/10.5 patients/100 treatment years. Thus discontinuation due to inefficacy was reported less frequently with ETA compared to ADA (p=0.046) and TOC (p<0.001) and with ADA compared to TOC (p<0.001).Patients on ETA and ADA had a slightly, but not statistically significant lower rate of withdrawal for ineffectiveness if on methotrexate (Figure 1). There was no difference regarding baseline disease activity parameters in patients with ETA/ADA monotherapy compared with combination with MTX, apart from patients with ETA+MTX receiving more often systemic steroids at baseline (36vs 24%,p<0-001). For both GOL and TOC treatment, no baseline differences in disease activity between cohorts with monotherapy and MTX combination could be shown. The combination with MTX led to significantly lower rates of discontinuation due to inefficacy (p<0.05) with GOL and TOC (Figure 1).Conclusion:Patients with pJIA mostly were treated with a combination of the biologic and MTX rather than with biologic monotherapy. Treatment was discontinued due to lack of efficacy in 14% to 28%. No statistically significant effect of combination treatment with MTX versus monotherapy could be observed regarding the rate of treatment failures in patients treated with ETA or ADA. However, combination treatment with MTX significantly prolonged the survival of GOL and TOC in patients with polyarticular JIA. The results are limited by low patient numbers in the GOL cohort and possible bias by JIA category.Figure 1.Kaplan Meier plot of drug survival in patients with monotherapy or with combination with MTX of the indicated biologicDisclosure of Interests:Gerd Horneff Speakers bureau: MSD, Grant/research support from: Pfizer, Roche, Chugai, MSD, Daniel Windschall: None declared, Kirsten Minden Speakers bureau: Pfizer, Abbvie, Grant/research support from: Pfizer, Toni Hospach: None declared, Frank Dressler: None declared, Frank Weller-Heinemann: None declared, Boris Huegle: None declared, Ivan Foeldvari Speakers bureau: Pfizer, Ariane Klein: None declared

scholarly journals AB0337 TOFACITINIB MONOTHERAPY OR COMBINED WITH METHOTREXATE IN PATIENTS WITH RHEUMATOID ARTHRITIS SHOW SIMILAR RETENTION OVER FOUR YEARS. REPORT FROM RHUMADATA ®

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1467.1-1467
Author(s):  
D. Choquette ◽  
L. Bessette ◽  
L. Choquette Sauvageau ◽  
I. Ferdinand ◽  
B. Haraoui ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Treatment Initiation ◽  
Retention Rate ◽  
Janus Kinase ◽  
P Value ◽  
Research Support ◽  
Medication Discontinuation ◽  
Kaplan Meier

Background:Since the introduction of biologic agents around the turn of the century, the scientific evidence shows that the majority of agents, independent of the therapeutic target, have a better outcome when used in combination with methotrexate (MTX). In 2014, tofacitinib (TOFA), an agent targeting Janus kinase 1 and 3, has reached the Canadian market with data showing that the combination with MTX may not be necessary [1,2].Objectives:To evaluate the efficacy and retention rate of TOFA in real-world patients with rheumatoid arthritis (RA).Methods:Two cohorts of patients prescribed TOFA was created. The first cohort was formed of patients who were receiving MTX concomitantly with TOFA (COMBO) and the other of patients using TOFA in monotherapy (MONO). MONO patients either never use MTX or were prescribed MTX post-TOFA initiation for at most 20% of the time they were on TOFA. COMBO patients received MTX at the time of TOFA initiation or were prescribed MTX post-TOFA initiation for at least 80% of the time. For all those patients, baseline demographic data definitions. Disease activity score and HAQ-DI were compared from the initiation of TOFA to the last visit. Time to medication discontinuation was extracted, and survival was estimated using Kaplan-Meier calculation for MONO and COMBO cohorts.Results:Overall, 194 patients were selected. Most were women (83%) on average younger than the men (men: 62.6 ± 11.0 years vs. women: 56.9 ± 12.1 years, p-value=0.0130). The patient’s assessments of global disease activity, pain and fatigue were respectively 5.0 ± 2.7, 5.2 ± 2.9, 5.1 ± 3.1 in the COMBO group and 6.2 ± 2.5, 6.5 ± 2.6, 6.3 ± 2.8 in the MONO group all differences being significant across groups. HAQ-DI at treatment initiation was 1.3 ± 0.7 and 1.5 ± 0.7 in the COMBO and MONO groups, respectively, p-value=0.0858. Similarly, the SDAI score at treatment initiation was 23.9 ± 9.4 and 25.2 ± 11.5, p-value=0.5546. Average changes in SDAI were -13.4 ± 15.5 (COMBO) and -8.9 ± 13.5 (MONO), p-value=0.1515, and changes in HAQ -0.21 ± 0.63 and -0.26 ± 0.74, p-value 0.6112. At treatment initiation, DAS28(4)ESR were 4.4 ± 1.4 (COMBO) and 4.6 ± 1.3 (MONO), p-value 0.5815, with respective average changes of -1.06 ± 2.07 and -0.70 ± 1.96, p-value=0.2852. The Kaplan-Meier analysis demonstrated that the COMBO and MONO retention curves were not statistically different (log-rank p-value=0.9318).Conclusion:Sustainability of TOFA in MONO or COMBO are not statistically different as are the changes in DAS28(4)ESR and SDAI. Despite this result, some patients may still benefit from combination with MTX.References:[1]Product Monograph - XELJANZ ® (tofacitinib) tablets for oral administration Initial U.S. Approval: 2012.[2] Reed GW, Gerber RA, Shan Y, et al. Real-World Comparative Effectiveness of Tofacitinib and Tumor Necrosis Factor Inhibitors as Monotherapy and Combination Therapy for Treatment of Rheumatoid Arthritis [published online ahead of print, 2019 Nov 9].Rheumatol Ther. 2019;6(4):573–586. doi:10.1007/s40744-019-00177-4.Disclosure of Interests:Denis Choquette Grant/research support from: Rhumadata is supported by grants from Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Consultant of: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Speakers bureau: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Loïc Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant of: Pfizer, Abbvie, Amgen, Novartis, Speakers bureau: Pfizer, Amgen, Boulos Haraoui Grant/research support from: Abbvie, Amgen, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, and UCB, Consultant of: Abbvie, Amgen, Lilly, Pfizer, Sandoz, UCB, Consultant of: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Merck, Pfizer, Roche, and UCB, Speakers bureau: Pfizer, Speakers bureau: Amgen, BMS, Janssen, Pfizer, and UCB, Frédéric Massicotte Consultant of: Abbvie, Janssen, Lilly, Pfizer, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: ArthroLab Inc., Grant/research support from: TRB Chemedica, Speakers bureau: TRB Chemedica and Mylan, Jean-Pierre Raynauld Consultant of: ArthroLab Inc., Marie-Anaïs Rémillard Consultant of: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Édith Villeneuve Consultant of: Abbvie, Amgen, BMS, Celgene, Pfizer, Roche, Sanofi-Genzyme,UCB, Paid instructor for: Abbvie, Speakers bureau: AbbVie, BMS, Pfizer, Roche, Louis Coupal: None declared

THU0399 HOW DO TNF-ALPHA-INHIBITORS IN MEDICAL HISTORY AFFECT PATIENT REPORTED OUTCOMES AND RETENTION IN ANKYLOSING SPONDYLITIS PATIENTS TREATED WITH SECUKINUMAB IN REAL WORLD? - GERMAN AQUILA STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 436-437
Author(s):  
U. Kiltz ◽  
J. Brandt-Juergens ◽  
P. Kästner ◽  
E. Riechers ◽  
D. Peterlik ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Outcomes ◽  
Medical History ◽  
Physical Functioning ◽  
Real World ◽  
Interim Analysis ◽  
Retention Rates ◽  
Research Support ◽  
Kaplan Meier

Background:Secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin 17A, is approved for treatment of patients with ankylosing spondylitis (AS). However, there is lack of real-world evidence on SEC treatment outcomes, disease activity, physical functioning and on its retention, especially in anti-tumor necrosis factor (anti-TNF) naïve patients and patients pretreated with different anti-TNFs in medical history.1Objectives:The aim of this interim analysis is to evaluate SEC treatment outcomes on disease activity, physical functioning and retention rates in AS patients stratified by number of anti-TNFs (naive, 1 or ≥2) in medical history.Methods:AQUILA is an ongoing, multi-center, non-interventional study. AS and psoriatic arthritis patients treated with SEC in daily practice are enrolled and observed from baseline (BL, d0 or d1 of study start) up to week 52 according to clinical routine. Real-world effectiveness of SEC was assessed prospectively and analyzed as observed. Here, we report interim results of SEC effectiveness on different treatment outcomes in AS patients by means of validated questionnaires such as patient´s global assessment (PGA), Bath Ankylosing Disease Activity Index (BASDAI), and Assessment of Spondyloarthritis Health Index (ASAS-HI). In addition, retention rates (time from study inclusion until premature SEC treatment discontinuation) were assessed through Kaplan-Meier plots. This interim analysis focuses onanti-TNF naïveand AS patients treated with1 anti-TNFor≥2 anti-TNFsin medical history. Wilcoxon tests were conducted to show significant differences between the subgroups.Results:At BL, 311 AS patients were included; 72 (23.2%) of them received SEC already for more than 1 day up to more than 6 months before BL. Most AS patients were anti-TNF-experienced (71.1%): 82 (26.4%) and 139 (44.7%) AS patients had 1 or ≥2 prior anti-TNF treatments, respectively. BL scores for PGA, BASDAI and ASAS-HI were similar between the different anti-TNF subgroups. Constant improvement was shown in all parameters from BL up to week 52, irrespective of prior anti-TNF treatment (PGA-anti-TNF naïve: 5.9 to 3.5, PGA-1 anti-TNF:6.1 to 4.2 and PGA-≥2 anti-TNFs:6.7 to 5.1; BASDAI-anti-TNF naïve: 5.3 to 3.4, BASDAI-1 anti-TNF:5.5 to 3.7 and BASDAI-≥2 anti-TNFs:5.7 to 4.7). However, overall better improvement was observed inanti-TNF naïvepatients, as seen by the example of ASAS-HI (Fig. 1). Between 30% and 40% of patients prematurely discontinued SEC treatment in the subgroups1 anti-TNFand≥2 anti-TNFs, respectively, while only about 20% did so in theanti-TNF naïveAS patients (Fig. 2).Conclusion:SEC has shown to improve disease activity, physical functioning and QoL in anti-TNF-naïve and pretreated AS patients in a real-world setting. The benefits of SEC were numerically more distinct in anti-TNF-naïve patients. Moreover, SEC demonstrated high retention rate, particularly in anti-TNF-naïve patients, thereby confirming previously reported real-world data on SEC from EuroSpA research collaboration network.2References:[1]Glintborg B, et al, Ann Rheum Dis 2013;72:1149-55; 2. Michelsen B, et al, Arthritis Rheumatol 2019:71(suppl10) #1822Disclosure of Interests: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, Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, SanofiFigure 1.Change of health in AS patients treated with SEC stratified by anti-TNF pretreatmentFigure 2.SEC treatment retention depending on anti-TNF pretreatment (Kaplan-Meier plot)

scholarly journals AB0740 SECOND-LINE BIOLOGIC DMARDs SURVIVAL IN PSORIATIC ARTHRITIS. DATA FROM A SPANISH THIRD-LEVEL HOSPITAL.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1665.2-1666
Author(s):  
J. Arroyo Palomo ◽  
I. Del Bosque Granero ◽  
A. Corral Bote ◽  
B. A. Blanco Cáceres ◽  
J. Bachiller-Corral
Keyword(s):  
Survival Analysis ◽  
Psoriatic Arthritis ◽  
Second Line ◽  
Hla B27 ◽  
First Line ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Level Hospital ◽  
Necrosis Factor ◽  
Axial Involvement

Background:Psoriatic arthritis (PsA) covers a wide spectrum of disease manifestations, including arthritis, enthesitis, dactylitis and axial spondylitis. This range of symptoms presents a challenge to the treating physician. Biologic disease-modifying antirheumatic drugs (bDMARDs) have proven effective through randomized clinical trials; and most international PsA guides include them as main option upon first-line treatment failure. However, studies regarding drug efficacy after bDMARD switching are scarce, lower response rates and drug survival on consecutive lines has been explored in previous research.Objectives:To assess bDMARDs survival after first-line failure in PsA patients treated in a third-level hospital and to determine baseline clinical and laboratory parameters associated with drug survival.Methods:We conducted a retrospective, single-centre study. 47 patients who received a second-line bDMARD were included, with diagnosis of PsA according to the criteria of an expert rheumatologist. All patients were studied according to a standard protocol. Data regarding bDMARD prescribed, baseline characteristics, axial or peripheral involvement and immunological profile (included both HLA-B27 and HLA-Cw6) were extracted. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at bDMARD start were included, as well. Kaplan-Meier, log-rank analyses and Cox regression models were applied.Results:Of 47 patients receiving a second bDMARD, 55,3% (26) were female and mean (S.D.) age was 40,6 (12,52) years. Median (interquartile range) disease duration was 10,1 (3,7-14,8) years. Prescribed drugs were Adalimumab (ADL) (36,2%, 17), Etanercept (ETN) (27,6%, 13), Infliximab (IFX) (6,4%, 3), Golimumab (GOL) (10,6%, 5), Certolizumab (CTZ) (4,3%, 2), Secukinumab (SCK) (8,5%, 4) and Apremilast (APR) (6,4%, 3). 42,3% cases suffered from axial involvement, rest of the sample (57,6%) presented a pure peripherical form of PsA. HLA-B27 and -Cw6 were assessed in 80,9% (38) and 68,1% (32), respectively; of whom, HLA-B27 carriers were 10,5% and HLA-Cw6 positive, 46,9%. Mean CRP level was 10,25 mg/L and mean ESR was 23,17 mm. Patients showed mean and median global drug retention of 44,57 (29,8-59,3) and 23 months. At 12-month visit, drug survival was 70%, 47% at 24 months, and 33% at 4 years from onset. Mean drug persistence by bDMARD prescribed was: ADL, 62,1 months; ETN, 51,9 months; IFX, 39 months; GOL, 22,8 months; CTZ, 9,5 months; SCK, 13,5 months; and APR, 16,3 months. Through log-rank analyses, differences in drug retention were investigated by several variables. Female sex (30,35m, 16,5-44,2 m.) was identified as statistically significant different than male patients (62,5m, 35,6-89,4m, p=0,021). Although not significant, other differences were remarkable: non-axial involvement, HLA-Cw6 negativity, HLA-B27 positivity and CRP level over 5 mg/L. No differences were found between altered and normal ESR patients.Conclusion:Second-line bDMARD survival is lower in female PsA patients, according to our data and previous bibliography. Despite our reduced sample and possible bias, non-axial involvement, absence of HLA-Cw6, presence of HLA-B27 and higher levels of CRP at biologic onset might be predictors of better drug persistence. Further investigations are required on this field.References:[1]Glintborg B et al. Clinical Response, Drug Survival, and Predictors Thereof Among 548 Patients With Psoriatic Arthritis Who Switched Tumor Necrosis Factor α Inhibitor Therapy. Results from the Danish Nationwide DANBIO Registry. Arthritis Rheum 2013:65(5):1213-23.[2]Stober C et al. Prevalence and predictors of tumour necrosis factor inhibitor persistence in psoriatic arthritis. Rheumatology (Oxford) 2018:57(1):158-163.Table 1. Kaplan–Meier survival analysis of persistence according to sex.Table 2. Kaplan Meier survival analysis of persistence according to HLA-Cw6.Disclosure of Interests:None declared

scholarly journals POS1053 COMPARISON OF BASELINE CHARACTERISTICS BETWEEN PATIENTS CONTINUING OR DISCONTINUING APREMILAST AT TWELVE MONTHS IN THE REWARD STUDY (THE NETHERLANDS)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 805.1-805
Author(s):  
R. Bos ◽  
T. Jansen ◽  
S. De Jong ◽  
A. Castiglia ◽  
M. Vis
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Interim Analysis ◽  
Disease Duration ◽  
Joint Involvement ◽  
Research Support ◽  
Mild Disease ◽  
Drug Survival ◽  
Baseline Characteristics

Background:Previous analysis of the REWARD study reported that patients with limited joint involvement have a considerable burden of disease1. Recent data suggest that patients with moderately active psoriatic arthritis (PsA) and a limited joint involvement have a high likelihood of achieving treatment goals when treated with apremilast2. According to EULAR recommendations a PDE4 inhibitor may be considered in patients with mild disease and an inadequate response to at least one csDMARD, in whom neither a bDMARD nor a JAK inhibitor is appropriate and the value of apremilast may be found in treating patients with relatively mild disease (oligoarticular)3.Objectives:The objective of this prospective, multicentre, non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast in patients with PsA. Patients will be followed up for a maximum of 12 months. This interim analysis compared the baseline characteristics and experience on apremilast for two subgroups of patients, those remaining on apremilast versus the ones that discontinued.Methods:In this interim analysis we included patients with data available at cut-off date of 03 November 2020. Patient enrollment and follow up of current subjects is ongoing. Descriptive statistics (n’s and percents for categorical data, means for continuous data) were used to summarize the baseline data by subgroup. Kaplan Meier plots are presented to show patients’ experience on apremilast by subgroup.Results:85 patients were included in the analysis. 30 patients have completed the study, 39 patients have discontinued and 16 are ongoing. At baseline 22 (26%) patients were biologic experienced and 62 (74%) were biologic naïve. Both groups had a comparable disease activity measured with clinical disease activity in psoriatic arthritis (cDAPSA) scores. Biologic experienced patients had a longer disease duration compared to biologic naïve patients (mean 9.7 vs 6.2 years). Inefficacy of previous medication was the main reason for starting apremilast in both subgroups. Overall, 86% (n=69) of patients were still receiving apremilast at month 3, 60% (n=46) at month 6, and 41% (n=26) at month 12 (Figure 1). Drug survival (length of time until discontinuation of apremilast) for biologic naïve patients was 93% at month 3, 73% at month 6 and 58% at month 12. Drug survival of biologic experienced patients was 67%, 20%, and 0% at months 3, 6, and 12, respectively. At baseline mean values of body mass index (BMI), swollen joint count (SJC), tender joint count (TJC), psoriatic arthritis impact of disease (PsAID) were comparable between both groups (Table 1). Reasons for discontinuation were mainly lack of efficacy (49%) and adverse events (44%). In this analysis the nature and frequency of adverse events is in line with the known profile of apremilast.Conclusion:In this interim analysis, patients who were biologic naïve had a better probability to remain on treatment than those who were biologic experienced. Baseline characteristics were similar between the two groups, apart from disease duration that was longer in the biologic experienced group. Best drug survival is achieved when apremilast is prescribed earlier in the PsA treatment course, before biologics and after csDMARDs, as per apremilast EU label.References:[1]Jansen TL, et al. Ann Rheum Dis. 2019;78:913 [abstract FRI0442][2]Mease PJ, et al. Arthritis Care Res 2020 72 6 814–821[3]Gossec L, et al. Ann Rheum Dis 2020;79:700–712Disclosure of Interests:Reinhard Bos Consultant of: AbbVie BV, Genzyme Europe, Janssen-Cilag, Novartis, Pfizer, Grant/research support from: Galapagos, Tim Jansen Consultant of: AbbVie, Celgene Corporation – consultant, Speakers bureau: Grunenthal, Sobi – speakers bureau, Grant/research support from: ReumaNederland, Olatec, Grunenthal – grant/research support, Sylvia de Jong Shareholder of: Employee of Amgen Inc, Employee of: Employee of Amgen Inc, Antonio Castiglia Shareholder of: Employee of Amgen Inc, Employee of: Employee of Amgen Inc, Marijn Vis Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer.

scholarly journals SAT0115 COGNITIVE IMPAIRMENT WAS FREQUENT IN PATIENTS WITH RHEUMATOID ARTHRITIS STARTING A BIOLOGIC, WITH SIMILAR RATES OF INHIBITION OR OVERSTIMULATION: AN ANALYSIS OF 84 PATIENTS FROM THE SARIPRO STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 991-992 ◽  
Author(s):  
H. Marotte ◽  
F. E. Lévy-Weil ◽  
R. M. Flipo ◽  
T. Schaeverbeke ◽  
E. Fakra ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cognitive Impairment ◽  
Disease Activity ◽  
Rheumatoid Factor ◽  
Exploratory Analysis ◽  
Inadequate Response ◽  
Cognitive Inhibition ◽  
Research Support ◽  
Lower Tertile ◽  
Patient Reported

Background:While cognitive impairment is an issue for patients with rheumatoid arthritis (RA), there are few data available on its frequency and possible link with other outcomes in RA.Objectives:To assess cognitive impairment in RA and its association with RA and patients’ characteristics.Methods:The SariPRO study (NCT 03449758) was a French multicenter study assessing the effects of sarilumab 200 mg on patient-reported outcomes in patients with moderately to severely active RA with an inadequate response or intolerance to conventional synthetic or biologic DMARDs. This report focuses on baseline data.The main outcome of this analysis was cognitive impairment evaluated by the cognitive sub-score of the patient-reported multidimensional assessment of mood disorders (MAThyS) scale. This sub-score is scored between 0 (i.e. feeling that thoughts occur slower) and 40 (i.e. racing thoughts) where 20 is the best state. This sub-score was analyzed by tertiles where the lowest tertile indicates general inhibition, the second tertile includes normal states, and the highest tertile indicates general excitation. In addition to the MAThyS total score and sub-scores (Cognition, Emotion, Psychomotricity, Motivation and Sense perception), age, gender, duration of RA, methotrexate use, antibody status (rheumatoid factor/ACPA positivity), fatigue (FACIT-F), anxiety /depression (HADS), as well as patient global assessment (PGA) were collected. Cognitive impairment was defined as inhibition (first tertile) and excitation (third tertile). The association between cognitive inhibition and patients’ characteristics (demographic, psychological and disease activity) was estimated by univariate and multivariate logistic regression in an exploratory analysis. There was no imputation of missing data.Results:In all 84 patients were included, characteristics at baseline were as expected for an RA population initiating a biologic: mean (SD) age: 59.1 (12.3) years, 75.0% female, disease duration 10.0 (10.3) years, rheumatoid factor positivity 76.1%, ACPA positivity 81.3%, and DAS28 5.0 (1.1). The mean (SD) MAThyS cognition score was 18.2 (4.9). In the exploratory multivariate analysis, factors associated to cognitive inhibition were depression (HADS depression score ≥ 8, odds ratio, OR=3.15 [95% confidence interval, 1.16; 8.59], p=0. 025), emotion inhibition (lower tertile of the MATHYS emotion regulation: OR=4.76 [1.54; 14.28]; p=0.007) and low motivation (lower tertile of motivation: OR=4.17 [1.54; 11.11]; p=0.005).Conclusion:Cognitive impairment was frequent in this population of patients with active RA, with similar rates of cognitive inhibition and cognitive excitation. The results suggest that there may be an association between cognitive inhibition, depression, emotion dysregulation and absence of motivation. Unexpectedly, this exploratory analysis did not show an association between cognition impairment and demographic characteristics or disease activity.References:[1]Study was sponsored by Sanofi GenzymeDisclosure of Interests:Hubert MAROTTE Grant/research support from: Bristol Myers Sqibb, Lilly France, MSD, Novartis, Nordic Pharma, Pfizer, SanofiAventis, Consultant of: AbbVie, Amgen, Bristol Myers Sqibb, Lilly France, MSD, Novartis, Nordic Pharma, Pfizer, SanofiAventis, Paid instructor for: Sanofi-Aventis, Speakers bureau: Sanofi-Aventis, Florence E Lévy-Weil Employee of: Sanofi Genzyme employee, René-Marc Flipo Consultant of: Johnson and Johnson, MSD France, Novartis, Sanofi, Speakers bureau: Johnson and Johnson, MSD France, Novartis, Sanofi, Thierry Schaeverbeke: None declared, Eric Fakra Consultant of: Janssen, Lundbeck, Otsuka, 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

scholarly journals AB0229 A NATIONAL, MULTICENTER, SECONDARY DATA USE STUDY EVALUATING EFFICACY AND RETENTION OF FIRST-LINE BIOLOGIC TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-LIFE SETTING FROM TURKBIO REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1140-1141
Author(s):  
A. Yazici ◽  
Ö. Özdemir Işik ◽  
E. Dalkiliç ◽  
S. S. Koca ◽  
Y. Pehlivan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Real World ◽  
Retention Rate ◽  
Real Life ◽  
Retention Rates ◽  
First Line ◽  
Research Support ◽  
Biologic Treatment ◽  
Number Of Patients

Background:Tocilizumab (TCZ) is a human anti-interleukin (IL)-6 receptor antibody approved in Turkey for the treatment of rheumatoid arthritis (RA).Objectives:In this study our purpose was to describe the disease activity, quality of life (QoL), and retention rate in RA patients who were prescribed TCZ as first-line biologic treatment in a real-world setting.Methods:Anonymized patient registry of TURKBIO was used based in a national, multicenter, and retrospective context. We conducted a search in the registry between years 2013 and 2020 and included adult RA patients who were prescribed with TCZ as their first-line biologic treatment with a post-TCZ follow-up of at least 6 months. CDAI, DAS28-(ESR), and HAQ-DI scores in 6, 12, and 24 months were obtained. Pairwise comparison was carried out for survey scores across baseline and timepoints. Subgroup analysis for route of TCZ administration was performed. EULAR response criteria were used for response evaluation. Retention of TCZ was evaluated by Kaplan-Meier analysis.Results:Overall,130 patients with a mean RA duration of14 years were included in the study. 87.7% of the patients were female and mean age was53 (SD; 15.0). Median duration of follow-up was 18.5 months. Majority (90.8%) of patients were given tocilizumab via intravenous route at baseline. Number of patients with ongoing TCZ treatment and follow-up at 6, 12, and 24 months were 121 (93%), 85 (65%), and 46 (35%), respectively. Remission rates at 6, 12, and 24 months per CDAI (<2.8) and DAS28-(ESR) (<2.6) scores were 61.5%, 44.6%, 30%, and 54.6%, 40.8%, 27.7%, respectively. CDAI, DAS28-(ESR) and HAQ-DI survey scores significantly improved at 6, 12 and 26 months, respectively (p<0.001) (Table 1) in both IV and SC TCZ subgroups. At 6, 12 and 24months 74.8%, 82.5% and 86.4% of patients achieved a EULAR good response respectively. Twenty-three patients (17.6%) discontinued TCZ at 24 months. Of these, 19 patients discontinued due to unsatisfactory response. Retention rates of TCZ at 6, 12, and 24 months were 93%, 84.3%, and 72.2%, respectively (Figure 1).Conclusion:TCZ as a first-line biologic treatment was found to be clinically effective in this real-world study with a high retention rate. These results are in line with the results gathered from previous TCZ controlled and real-life studies in which TCZ was found clinically safe and effective.References:[1]Haraoui B, Casado G, Czirjak L, Taylor A, Dong L, Button P, Luder Y, Caporali R. Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies. Rheumatol Ther. 2019 Jun;6(2):231-243.[2]Favalli EG, Raimondo MG, Becciolini A, Crotti C, Biggioggero M, Caporali R. The management of first-line biologic therapy failures in rheumatoid arthritis: Current practice and future perspectives. Autoimmun Rev. 2017 Dec;16(12):1185-1195.[3]Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results from an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec; 5(2): 551–565.Disclosure of Interests:Ayten Yazici Speakers bureau: PFIZER, AbbVie, NOVARTIS, Özlem Özdemir Işik: None declared, Ediz Dalkiliç Speakers bureau: AbbVie, UCB Pharma, PFIZER, Roche, MSD, NOVARTIS, Süleyman Serdar Koca Speakers bureau: MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, SANOFİ, Yavuz Pehlivan Speakers bureau: PFIZER, NOVARTIS, MSD, CELLTRION, Consultant of: PFIZER, Soner Şenel: None declared, Nevsun Inanc Speakers bureau: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Paid instructor for: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Consultant of: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Grant/research support from: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Servet Akar Speakers bureau: LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, Paid instructor for: LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB, AMGEN, Grant/research support from: PFIZER, Sema Yilmaz: None declared, Özgül Soysal Gündüz: None declared, Ayse Cefle Speakers bureau: UCB Pharma, PFIZER, MSD, AbbVie, AMGEN, NOVARTIS, Fatos Onen Speakers bureau: AbbVie, LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Paid instructor for: AbbVie, LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Grant/research support from: PFIZER

scholarly journals AB0236 DIFFERENCES AND DETERMINANTS OF PHYSICIAN’S AND PATIENT’S PERCEPTION IN GLOBAL ASSESSMENT OF RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1418.1-1418
Author(s):  
S. Azevedo ◽  
F. Guimarães ◽  
D. Almeida ◽  
D. Faria ◽  
J. Silva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatoid Factor ◽  
Global Assessment ◽  
Short Form ◽  
Biologic Treatment ◽  
Disease Evolution ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Of Disease Activity

Background:Patient’s Global Assessment of Disease Activity (PtGA) and Physician’s Global Assessment of Disease Activity (PhGA) are assessed as part of commonly used measures of disease activity in RA.1Both are important measures in treat-to-target strategies in Rheumatoid Arthritis (RA), but often provide discordant results.2,3This can provide an erroneous assessment of disease activity in patients under Biologic treatment and mislead treatment decisions, namely switches.Objectives:To assess differences and determinants of PtGA and PhGA in RA patients under biologic treatment.Methods:Cross-sectional study, including 46 patients with RA diagnosed according to the ACR/EULAR criteria, under biologic treatment, consecutively evaluated in day-care unit. Participants completed patient-reported outcomes (PROs), including PtGA, and sociodemographic characteristics. Physicians collected comorbidities and parameters of inflammatory activity (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]) and completed PhGA and disease activity score 28 with ESR (DAS28). SPSS was used for statistical analysis and significance level was defined as 2-sided p<0.05.Results:Clinical and laboratory characteristics of patients are shown in table 1. PtGA and PhGA were significantly different (36.1±27.6 mmvs8.7±14.2 mm, p< 0.001) and a positive discordance (PtGA>PhGA, more than 25mm in visual analogue scale [VAS]) was found in 54.3% of cases.PtGA had a correlation with PROs (Pain VAS, 36-Item Short Form Health Survey [SF-36], Health Assessment Questionnaire [HAQ], Functional Assessment of Chronic Illness Therapy [FACIT], EuroQol [EQ5D] and Hospital Anxiety and Depression Scale [HADS]), CRP, tender and swollen joint counts and an association with comorbidities like fibromyalgia or osteoarthritis (OA). No association was found between PtGA and age, sex, education level, profession, employment status, extra-articular manifestations, positivity of rheumatoid factor, ESR, years of disease evolution or number of biologic treatments. In multivariable analyse including SF-36, CRP, tender joints count and OA (R2adjusted= 0.672), the main predictors of PtGA were lower SF36, concomitant OA and higher CRP level.PhGA had a correlation with PtGA, pain VAS, CRP, tender and swollen joints. No association was found between PhGA and patient or physician age, patient or physician sex, extra-articular manifestations, positivity of rheumatoid factor, ESR level, years of disease evolution or number of biologic treatments. In multivariable analysis including ESR, tender and swollen joints count and CRP (R2adjusted= .800), the main predictors of PhGA were swollen joint count and higher CRP level.Conclusion:This study showed the variability implied on global assessment of RA activity. Overall PtGA is based on function and also in subjective and emotional experience of pain, whereas the PhGA is based on more objective measures, more related to disease activity.References:[1]Kanekoa Y. et al, Determinants of Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity in patients with rheumatoid arthritis: A post hoc analysis of overall and Japanese results from phase 3 clinical trials.Modern Rheumatology2018; 28(6):960–967[2]Furu M. et al. Discordance and accordance between patient’s and physician’s assessments in rheumatoid arthritis.Scand J Rheumatol.2014; 43(4):291-5.Ann Rheum Dis. 2016 Sep;75(9):1661-6. doi: 10.1136/annrheumdis-2015-208251. Epub 2015 Oct 22.[3]Portier A. et al, Patient-perceived flares in rheumatoid arthritis: A sub-analysis of the STRASS treatment tapering strategy trial.Joint Bone Spine. 2017; 84(5):577-581Disclosure of Interests:None declared

scholarly journals DISEASE ACTIVITY INDICES AND C-REACTIVE PROTEIN PREDICT SWITCHING OF THE FIRST BIOLOGICAL AGENT IN ANKYLOSING SPONDYLITIS PATIENTS – A SINGLE-CENTER OBSERVATIONAL STUDY

2017 ◽  
Vol 26 (3) ◽  
pp. 122-128
Author(s):  
Marius Trandafir ◽  
◽  
Claudiu C. Popescu ◽  
Monica Gabriela Dimancescu ◽  
Florian Berghea ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Retention Rate ◽  
Inactive Disease ◽  
Biologic Agent ◽  
Acute Phase Reactants ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Active Disease ◽  
Activity Indices

Objective. The study aimed at observing drug survival and determining potential predictors of anti-TNFα switch among ankylosing spondylitis (AS) patients. Methods. The study retrospectively recorded clinical data of patients fulfilling modified New York criteria in a single university clinic. The data were analyzed using appropriate statistical test, which were considered significant if p < 0.05. Results. A total of 120 patients met the inclusion criteria. Switchers had a median BASFI score of 2.7, a median ASDASCRP of 1.59 and a 41.7% prevalence of uveitis, compared to non-switchers which had a median BASFI score of 2.0, a median ASDASCRP of 1.20 and a uveitis prevalence of 22.9% respectively (p = 0.009; p = 0.025; p = 0.043). After a median of 7.0 years of observation, 96 patients (80.0%) were still being treated with their first anti-TNFα agent, with a Kaplan-Meier survival time estimate of 11.5 (10.1-12.9) years. The Kaplan-Meier study of the time of treatment until switch of the first biologic agent according to ASDASCRP categories revealed 9.3 (8.8-9.8) years for inactive disease, 10.6 (8.8-12.5) years for moderately active disease and 7.1 (5.7-8.5) years for highly active disease. The switch hazard ratio for CRP was 1.019 (1.007-1.031; p = 0.002), for BASDAI 1.226 (1.017-1.477; p = 0.032), for BASFI 1.264 (1.057-1.513; p = 0.010) and for ASDASCRP 1.592 (1.173-2.159; p = 0.003). Conclusion. Romanian AS patients on anti-TNFα agents exhibit high retention rate and drug survival of anti-TNFα agents. Switchers have significantly higher baseline disease activity indices which, along baseline acute phase reactants, can significantly predict switching of the first anti-TNFα agent. Patients with AS treated with anti-TNFα agents had a higher prevalence of uveitis than those who did not therapeutic switch.

First-Line Biologic Therapy and Obesity in Moderate-to-Severe Psoriasis: Results from the Prospective Multicenter Cohort Psobioteq

Dermatology ◽  
2021 ◽  
pp. 1-9
Author(s):  
Florence Assan ◽  
Florence Tubach ◽  
Hugo Arlegui ◽  
Manuelle Viguier ◽  
Marie Beylot-Barry ◽  
...  
Keyword(s):  
Biologic Therapy ◽  
Severe Psoriasis ◽  
Obese Patients ◽  
First Line ◽  
Biologic Treatment ◽  
Factors Associated ◽  
Drug Survival ◽  
Multicenter Cohort ◽  
Increased Risk ◽  
Pharmacological Studies

<b><i>Background:</i></b> Obesity is associated with an increased risk of psoriasis. <b><i>Objective:</i></b> In this study, we examined whether body mass index (BMI) is taken into account when choosing first-line biologic therapy for psoriasis. <b><i>Methods:</i></b> In this cohort study, we compared obese (BMI ≥30 kg/m<sup>2</sup>) and non-obese patients for the first-line biologic therapy prescribed, its survival, reasons for discontinuation, therapy optimization, co-prescription of methotrexate and factors associated with long drug survival. <b><i>Results:</i></b> A total of 931 patients were included: 594 (64%) were male, median age was 46 years (interquartile range 36–56). The most-prescribed biologic agents as first-line treatment were adalimumab (ADA; 42.7%), ustekinumab (UST; 29.9%) and etanercept (ETA; 22.9%); only frequency of infliximab (IFX) prescription differed between groups. Drug survival was significantly shorter for obese than non-obese patients (<i>p</i> &#x3c; 2.10<sup>–4</sup>) and was worse for obese than non-obese patients for UST (<i>p</i> = 0.009) and ETA (<i>p</i> = 0.02), with no difference for ADA (<i>p</i> = 0.11). The main reason for discontinuation was primary inefficacy (62%), which was more frequent in obese than non-obese patients. The cumulative incidence of optimization did not significantly differ between the groups, except for ADA (SHR 1.91, 95% CI [1.23–2.96], <i>p</i> = 0.005). On multivariate analysis, risk of discontinuation was associated with only ETA as first-line biologic therapy (HR 1.51, 95% CI 1.04–2.19). <b><i>Conclusion:</i></b> This study highlighted the lack of difference in prescription of first-line biologic treatment, except for IFX, between obese and non-obese patients presenting moderate-to-severe psoriasis. Drug survival in obese patients is shorter, mainly because of inefficacy, than in non-obese patients. This highlights the need for targeted pharmacological studies in obese individuals to find optimal administration schemes.

Anti-carbamylated Protein Antibodies and Serum Level of 14-3-3 Protein for Early Detection of Rheumatoid Arthritis Patient in Correlation with Rheumatoid Factor, Anti-CCP Antibodies, Disease Activity and Joint Damage using High Frequency Musculoskeletal Ultrasound

2020 ◽  
Vol 7 (2) ◽  
pp. 141-153
Author(s):  
Sahar A. Ahmed ◽  
Enas M. Darwish ◽  
Walaa A. Attya ◽  
Mai Samir ◽  
Mennatallah Elsayed ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatoid Factor ◽  
Disease Activity Score ◽  
Joint Damage ◽  
Musculoskeletal Ultrasound ◽  
Activity Score ◽  
Das 28 ◽  
Significant Difference ◽  
Hands And Feet

Background: Rheumatoid arthritis (RA) is a common progressive chronic inflammatory autoimmune disease which affects mostly small joints, causing pain, swelling, deformity, and disability. Although progress has been made in exploring RA nature, still there is a lot to know about the disease pathogenesis, diagnosis, and treatment. Aim of the Work: To investigate the role of serum anti-carbamylated protein antibodies and 14-3-3η in the diagnosis of RA compared to rheumatoid factor (RF), anti-CCP antibodies, and highfrequency musculoskeletal ultrasound used to assess the disease activity and joint damage. Methods: Serum anti-carbamylated protein antibodies and 14-3-3η were measured using ELISA in 61 RA patients and 26 normal controls. RA Disease Activity Score (DAS 28), X-ray and musculoskeletal ultrasound (hands and feet), carotid ultrasound (Intima-Media Thickness IMT) were used in assessing the RA disease. Results: Anti-carbamylated protein antibodies were significantly elevated in RA patients 4.5 (4.1- 8.9 U⁄ml) compared to the control 3.2(1.9- 4.3 U⁄ml) (p< 0.001) but 14-3-3η showed no significant difference. There was a significant positive correlation between anti-carbamylated protein antibodies, 14-3-3η levels and disease activity score assessed by DAS 28, increased IMT measured by carotid duplex, total synovitis and total erosion score were assessed by musculoskeletal ultrasound. There was no correlation between RF and anti-CCP antibodies. Anti-carbamylated protein antibodies were found to have 66.7% sensitivity and 85.2% specificity in RA diagnosis, while 14- 3-3η had 51.9% sensitivity and 72.1% specificity. Conclusion: Anti-carbamylated protein antibodies and 14-3-3η have a high sensitivity and specificity in RA diagnosis and had a correlation with the disease activity and joint damage.

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