AB0426 Biologic Spacing in Rheumatoid Arthritis Patients in Persistent Disease Activity Control: A Real Life Experience

Abstract Objectives Rituximab (RTX) use in the treatment of RA can be complicated by decrease in IgG, IgM or IgA levels (hypogammaglobulinemia-HGG). The aim of this study was to define the frequency of HGG in RA patients treated with RTX and to identify associations between its occurrence and patients’ characteristics, disease outcomes and serious infections rate. Methods RA patients treated with RTX in two rheumatology centers from January 2007 to January 2020 were retrospectively examined. Demographical, clinical and laboratory parameters were recorded at baseline and at last visit. Results Eighty-three patients (84.3% females) with a mean age of 63.2 years were enrolled. They had baseline DAS28(CRP) of 5.2 (1.1) and received a median (range) of 8 (2–20) RTX cycles. A total of 43.4%, 24.1% and 31.3% developed ‘any HGG’, ‘low IgG’ and ‘low IgM’, respectively. Lower baseline IgG and IgM levels were predictors of ‘low IgG’ and ‘low IgM’ occurrence, respectively. Patients who developed ‘low IgM’ exhibited lower DAS28(CRP) and increased rates of remission and low disease activity compared with those with normal IgM levels. Patients who maintained normal IgG were receiving methotrexate more frequently. No differences were observed in serious infections rate among subgroups. Conclusion HGG occurred in 43% of RTX-treated patients. Patients who developed low IgG or low IgM had lower baseline levels than those who did not. Concomitant DMARD and corticosteroid therapy was not associated with HGG. Low IgM, but not low IgG, development was associated with better disease outcomes. HGG was not associated with an increased incidence of serious infections.

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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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SAT0170 Bdmards Mono vs Combo Therapy in Rheumatoid Arthritis. Analysis of A Rheumatological Single Tertiary Center Real-Life Experience

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-eular.6015 ◽

2016 ◽

Vol 75 (Suppl 2) ◽

pp. 728.2-729

Author(s):

I. Farina ◽

E. Galuppi ◽

B. Abdel Hafith ◽

A. Lo Monaco ◽

M. Govoni

Keyword(s):

Rheumatoid Arthritis ◽

Life Experience ◽

Real Life ◽

Tertiary Center

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Unmet needs in the treatment of rheumatoid arthritis. An observational study and a real-life experience from a single university center

Seminars in Arthritis and Rheumatism ◽

10.1016/j.semarthrit.2018.06.003 ◽

2019 ◽

Vol 48 (4) ◽

pp. 597-602 ◽

Cited By ~ 19

Author(s):

Evripidis Kaltsonoudis ◽

Eleftherios Pelechas ◽

Paraskevi V. Voulgari ◽

Alexandros A. Drosos

Keyword(s):

Rheumatoid Arthritis ◽

Observational Study ◽

Unmet Needs ◽

Life Experience ◽

Real Life ◽

University Center

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AB0179 BEYOND DISEASE ACTIVITY, PAIN, “TIME” AND “TIMING” ACCOUNT FOR DISABILITY IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS FROM A REAL-LIFE COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1089 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1389-1389

Author(s):

H. Assunção ◽

A. R. Prata ◽

M. Luis ◽

L. Brites ◽

J. Dinis de Freitas ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Functional Disability ◽

Disease Duration ◽

Univariate Analysis ◽

Real Life ◽

Severe Disability ◽

Self Perception ◽

Modifiable Factors ◽

Time To Diagnosis

Background:Patients with rheumatoid arthritis (RA) suffer from joint pain, stiffness and fatigue and are therefore limited in their physical activities. Since functional disability is a major determinant of quality of life in patients with RA, an optimized approach should focus on the maintenance of functional ability.Objectives:To evaluate self-reported disability in RA patients and to identify its influencing clinical and demographic factors in a real-life cohort of patients with RA.Methods:Cross-sectional study of consecutive patients with RA fulfilling the ACR/EULAR 2010 and/or ACR 1987 RA classification criteria, followed in a Portuguese tertiary care centre. Variables collected included socio-demographic and clinical variables (disease duration; time from symptoms onset to diagnosis, classified as short (≤ 2 years) and long (> 2 years); time of diagnosis, categorised as <2000, 2000-2009, ≥2010); DAS28-CRP-3V and its individual components; pain assessed through visual analogue scale (0-100 mm) and self-perception of anxiety/ depression through EQ5D dimension 5. Disability was assessed through Health Assessment Questionnaire (HAQ) score and categorised as none-to-mild (<1) or moderate-to-severe (1-3). Comparison between groups was assessed through chi-square or T-student test, as adequate. Variables with p<0.1 and others clinically relevant in the researcher’s perspective were included in a multivariable logistic regression model. Previously to the analysis, all the assumptions were verified. Given the implementation of new strategies regarding diagnosis and treatment of RA in the last decade, a subgroup analysis was performed for patients with diagnosis performed after 2010).Results:A total of 251 patients were included (78.9% female, aged 62.0±12.1 years, disease duration 16.7±11.2 years), with a mean DAS28-CRP-3V of 2.24 ±0.87, with 65.3% being in remission or low disease activity. The mean HAQ score was 1.2±0.8. Over half of the patients (56.2%) reported moderate-to-severe disability. In the univariate analysis, moderate-to-severe disability was more frequent in female patients (60.6% vs 39.6%, p<0,006), in patients with moderate-to-severe self-perception of anxiety/depressive symptoms (67.2% vs 44.2%, p<0.001) and in patients with diagnosis before the year 2000, 2000-2009 than ≥2010 (71.4% vs 63.1% vs 36.7%; p< 0.001). In addition, patients with moderate-to-severe disability tended to be older (65.05 vs 57.98, p<0,001), to have longer disease duration (20.07 vs 12.39, p <0.001), to report more pain (VAS 58.08 vs 28.62, p<0.001) and to have higher disease activity (2.48 vs 1.95, p=0.001). In the multivariable analysis, pain (OR=1.04; 95%CI 1.03-1.06, p<0.001), disease activity (OR=1.51; 95%CI 1.01-2.26, p=0.049), and time of diagnosis (OR=0.553, 95%CI 0.38 -0.81, p=0.002) remained as independent factors associated with moderate-to-severe disability (R2: 0.40, p<0,001). In the subgroup of patients diagnosed after 2010, a longer time to diagnosis (>2 years) (OR=7.97, 95%CI 1.88-34.06; p=0.005) and pain (OR=1.05, 95%CI 1.03-1.08; p<0,001) remained as independent factors (R2= 0.44, p=<0.001).Conclusion:Functional disability remains a major problem in our patients with RA, despite clinical remission. Beyond non-modifiable factors, disease activity and pain are associated with higher disability. Moreover, in the subgroup of patients diagnosed after 2010 a long time to diagnosis was the major predictor of disability. However, a large variance of the reported functional disability remains unexplained. Hence, other factors should be properly evaluated in our patients in order to achieve a more holistic approach aiming at reducing functional disability.Disclosure of Interests:Helena Assunção: None declared, Ana Rita Prata: None declared, Mariana Luis: None declared, Luisa Brites: None declared, João Dinis de Freitas: None declared, Flavio Costa: None declared, Stefanie Silva: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, Catia Duarte: None declared

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Biologics registries

Oxford Textbook of Rheumatology ◽

10.1093/med/9780199642489.003.0034_update_002 ◽

2013 ◽

pp. 257-263

Author(s):

David Isenberg ◽

Angela Zink

Keyword(s):

Rheumatoid Arthritis ◽

Life Experience ◽

Real Life ◽

Cancer Development ◽

Controlled Trials ◽

Side Effect Profile ◽

Risk Of Infection ◽

Biologic Drugs ◽

Double Blind

Double-blind controlled trials undertaken over the past two decades have established the short-term effectiveness and side-effect profile of biologic drugs for patients with rheumatoid arthritis and related diseases. However, the development of biologics registers to capture ’real-life experience’ and explore long-term effectiveness and complications is equally important. In this chapter, we demonstrate how these registers have identified long-term joint benefits, a reduction in cardiovascular mortality, reassurance concerning fears about cancer development, and a balanced view of the risk of infection.

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P664 The impact of vedolizumab on extra-intestinal manifestations in inflammatory bowel disease patients: A real-life experience of a single-centre cohort

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.792 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S546-S547

Author(s):

M TRUYENS ◽

J Geldof ◽

G Dewitte ◽

E Glorieus ◽

G Varkas ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Disease Activity ◽

Bowel Disease ◽

Life Experience ◽

Real Life ◽

Intestinal Disease ◽

Single Centre ◽

Clinical Evolution ◽

Inflammatory Bowel ◽

The Impact

Abstract Background Vedolizumab (VDZ), a gut-specific anti-integrin, is approved as a treatment for moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). Extra-intestinal manifestations (EIMs) are frequently associated with inflammatory bowel disease (IBD). However, the effect of VDZ on EIMs remains unknown. The aim of the current study was to describe the prevalence of EIMs in IBD patients at VDZ initiation, the evolution during continued treatment as well as the occurrence of new EIMs. Methods A single-centre study was performed in IBD patients who were started on VDZ between May 2010 and February 2019. Retrospectively, the physician-reported EIMs and intestinal disease activity (clinical and endoscopic) were assessed at baseline, 6 months and 1 year after the start of VDZ. Results The cohort consisted of 134 patients, including 77 CD patients, 56 UC patients and 1 patient with unclassified IBD. At VDZ initiation EIMs were assessed in 127 patients and 17.3% had ≥ 1 EIM: 9 hepatic EIMs (2 patients with toxic hepatitis, 2 with autoimmune hepatitis and 5 with PSC), 7 arthropathies (6 patients with axial spondyloarthropathy and 1 with peripheral arthritis), 3 non-further specified axial or peripheral arthralgias and 3 cutaneous EIMs (urticaria, psoriasis and erythema nodosum). Clinical evolution of the EIMs is reported in Table 1, assessment of intestinal disease activity in Table 2. During follow-up, 23 new EIMs were seen, mainly arthralgia, which was often transient. VDZ was stopped in 39/130 (30%) patients due to active intestinal disease in 32 patients, patients’ choice (n = 1) or because of deep disease remission (n = 1). In five patients, VDZ was stopped because of insufficient control of EIM. Conclusion A good clinical intestinal response was observed. However, the clinical evolution of EIMs appears unaffected by the use of VDZ in our cohort. Prospective data are needed to confirm these results.

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