Laryngeal complaints and videolaryngoscopic laryngeal alterations in rheumatoid arthritis patients and its association with disease activity and duration

2019 ◽  
Vol 11 (5) ◽  
pp. 216-223
Author(s):  
Mohamed Baraka ◽  
Hossam ElDessouky ◽  
Alaa Abdel Azeez Labeeb ◽  
Eman Ezzat ◽  
Asmaa ElDessouky
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Systemic Disease ◽  
Vocal Folds ◽  
Moderate Activity ◽  
University Hospitals ◽  
Self Assessment ◽  
Perceptual Assessment ◽  
The Impact

Background: Rheumatoid arthritis (RA) is an autoimmune systemic disease with a wide clinical presentation. The laryngeal manifestations are often masked by the articular disability often experienced in the early and late stages of the disease. Objective: Association between different laryngeal complaints and videolaryngoscopic laryngeal alterations in patients with RA, and disease activity and duration. Patients and methods: A retrospective study was conducted on 79 patients with RA. All subjects were recruited from the out-patient clinic of physical medicine, rehabilitation, and rheumatology in Al-Menoufia University Hospitals during the period from March 2015 to March 2017. All patients were subjected to both phoniatric and rheumatological assessment. Results: Patients with phonasthenic symptoms and globus pharynges had significantly (p=0.01, 0.008 respectively) higher disease duration than patients without. No significant association found between rheumatoid arthritis duration and different videolaryngoscopic laryngeal alterations, patient’s self-assessment of the impact of laryngeal complaints on their lives, and auditory perceptual assessment (APA) of patient’s voice characters. As regards rheumatoid disease's activity no significant correlation has been established (p>0.05) with different laryngeal complaints except for patients in remission who had higher prevalence of intermittent dysphonia than patients with low activities. Rheumatoid disease's activity had no significant association with different laryngeal findings except those with moderate activity; they had significantly higher prevalence of vocal folds nodules than patients with high activity and patients in remission. Conclusion: A significant association between the disease's duration and presence of laryngeal complaints, dysphonia, and its persistence has been established. Also, patients with phonasthenic symptoms and globus pharynges had significantly higher disease duration than patients without. Rheumatoid diseases activity had significant association with different laryngeal complaints in patients with remission that had higher prevalence of intermittent dysphonia than patients with low activities. No significant association between the disease activity and different laryngeal findings that has been found except for patients with DAS-28>3.2, they had significantly higher prevalence of rheumatoid nodules.

scholarly journals OP0299 IN RHEUMATOID ARTHRITIS PATIENTS HIGHER NUMBER OF COMORBIDITIES PREDICTS 6-MONTH INSUFFICIENT RESPONSE TO FIRST BIOLOGIC THERAPY AND EVENTUAL CATEGORIZATION OF THE DISEASE AS DIFFICULT-TO-TREAT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 184.2-184
Author(s):  
I. Flouri ◽  
A. Repa ◽  
N. Avgustidis ◽  
N. Kougkas ◽  
A. Eskitzis ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Response To Therapy ◽  
Disease Classification ◽  
University Hospital ◽  
Tnf Inhibitor ◽  
Definition Of ◽  
The Impact

Background:Difficult-to-treat rheumatoid arthritis (D2T RA) was recently defined by a EULAR study group (1) and, as a disease category it is largely complicated and under-researched. Patient comorbidities may play a significant role in the response to therapy with biologic disease-modifying antirheumatic drugs (bDMARDs) and in the disease classification as D2T RA.Objectives:To evaluate the impact of comorbidities [studied as total Comorbidities Count (CC) and rheumatic disease comorbidity index (RDCI)] on 6-month response to therapy with the first bDMARD in real-world clinical practice and on eventual disease designation as D2T RA.Methods:Prospective study of all RA patients who start any bDMARD in a tertiary centre University Hospital after their consent. All patient comorbidities [among a list of approximately 100 pre-specified major comorbidities] are registered by treating physicians. Response to therapy was defined as achievement of low disease activity or remission (LDA/Rem) according to simplified disease activity index (SDAI) and health assessment questionnaire (HAQ) improvement of ≥ 0.25.D2T RA patient group was defined according to the EULAR definition of D2T RA and was compared to: a/ all other patients and b/ to a sub-group of patients designated as “well-controlled RA” (follow-up ≥2 years and ≥2 visits in the last year in LDA/Rem).Logistic regression models were used to adjust for the potential confounding of age, sex, disease duration, seropositivity, number of previous synthetic DMARDs, type of 1st bDMARD initiated (TNF inhibitor vs. non-TNF inhibitor), co-administered methotrexate and corticosteroids (yes/no), baseline SDAI and HAQ and year of therapy start.Results:Analysis included 501 RA patients who received a total of 1098 bDMARD treatments. At 1st bDMARD treatment start, patients (women: 81%) had a median (IQR) age: 60 (51-68) years, disease duration: 5.4 (3-11) years, SDAI: 36 (28-46), HAQ: 1.0 (0.5-1.5), CC: 3 (2-6) και RDCI: 2 (0-3).In adjusted analyses, total comorbidity count (CC) ≤1 (vs ≥ 2) was predicting LDA/Rem at 6 months of therapy [OR (95%CI) = 4.1 (1.5-11), p=0.005], while RDCI=0 (vs. ≥ 1) was predicting HAQ improvement ≥ 0.25 [OR (95% CI) = 2.6 (1.2-6.7), p=0.046].During 2614 patient-years of follow-up, the disease in 98 patients could be classified as “D2T RA”, while 127 patients had “well-controlled RA”. Baseline independent predictors for D2T RA compared to all other patients were RDCI ≥ 1 (vs. 0) [OR = 3.3 (1.7-9.4), p = 0.024], female sex [OR =3.1 (1.01-9.5)] and age [OR = 0.97 (0.94-0.99)]. Multivariable analyses for predictors of “D2T” compared to “well-controlled” RA yielded similar results.Conclusion:In RA patients starting the first bDMARD treatment, a higher number of comorbidities at baseline is an independent predictor of lower 6-month response to therapy and final disease classification as “difficult-to-treat” RA.References:[1]Nagy G, Roodenrijs NM, Welsing PM, Kedves M, Hamar A, van der Goes MC, et al. EULAR definition of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis. 2021 Jan;80(1):31–5.Acknowledgements:Pancretan Health Association and Special Account for Research Grants (ELKE) – University of Crete.Disclosure of Interests:None declared.

scholarly journals The impact of T2T therapy on the treatment of the patients with the early rheumatoid arthritis (data from OREL registry)

2021 ◽  
Vol 59 (3) ◽  
pp. 269-274
Author(s):  
V. V. Rybakova ◽  
A. S. Avdeeva ◽  
D. A. Dibrov ◽  
E. L. Nasonov
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
High Activity ◽  
Intensive Therapy ◽  
Long Term Results ◽  
Moderate Activity ◽  
Treatment Target ◽  
Low Disease Activity ◽  
Synthetic Dmards ◽  
The Impact

Aim – to analyze long-term results of intensive treatment initiated at rheumatoid arthritis (RA) onset in real clinical practice.Material and methods. 93 RA patients were included. Subcutaneous MTX was initiated at 10–15 mg per week with further dose escalation up to 20–30 mg per week. If MTX monotherapy did not allow to achieve treatment target of remission or low disease activity, biologics were added.Results. Against the background of observation, there was a significant decrease in the activity of diseases and the level of acute phase indicators, after 12 months of treatment, the values of the DAS28-ESR indices were 2.76 [2; 3.7], SDAI – 5.34 [1.8; 9.7], CDAI – 5 [1.5; 9.5], corresponded to low disease activity; remission was achieved in 48.6%, low activity – in 17.5%, moderate activity remained in 31%, high activity – in 2.7% of patients. After 6 years the median age of patients was 58 [49; 66] years, the disease duration – 84 [79; 89] months, the low disease activity was documented in 21.3%, and remission – in 7.8% of patients. After 6 years, the value of the activity indices was: DAS28 – 4 [3.4; 4.59], SDAI – 15.06 [9.32; 21], CDAI – 15 [9; 21]; remission – in 7.7%, low disease activity – in 21.1%, moderate activity – in 60%, high activity – in 11.1% of patients.Conclusion. Intensive therapy initiated at RA onset demonstrates high effectiveness, allowing to achieve remission/low disease activity in about 30% of patients. Adherence to this strategy allowed to discontinue biologics in and synthetic DMARDs after achieving treatment target.

scholarly journals AB0711 FOLLOW-UP OF PATIENTS UNDER BIOLOGICS IN THE ERA OF LOCKDOWN

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1387.2-1387
Author(s):  
V. F. Boussougou ◽  
K. Nassar ◽  
S. Janani
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
University Hospital ◽  
Inflammatory Rheumatic Diseases ◽  
Moderate Activity ◽  
Healthcare Facilities ◽  
French Study ◽  
Patient Reported ◽  
The Impact

Background:The management of patients with inflammatory rheumatic diseases under biologics has raised many questions about the global management of patients in the time of COVID-19 pandemic. This period could have been particularly painful for the patients due to the virus itself, and to the difficulty to access to healthcare facilities due to the lockdown.Objectives:To assess the impact of the lockdown in patients under biologics.Methods:This is a descriptive study, conducted between 03/01/2021 and 07/31/2021 in the Department of Rheumatology of the University Hospital of Ibn Rochd in Casablanca. Inclusion criteria were all patients on biologics during the lockdown period. The number of painful, swollen joints, pain visual analogue scale, and disease activity were collected before and during the lockdown.Results:Thirty-one patients under biologics were included. The average age was 43.4 years. There were 17 males and 14 females (sex ratio M/F 1,21). Cormibidities were hypertension and type 2 diabetes (9.7%), hypertension and dyslipidemia (6.5%), arrhythmia (6.5%), smoking (9.7%), hypertension and dysthyroidism (3.2%). All the patients were under biologics with an average duration of 2 years distributed as follows: 3 patients on etanercept (9.67%), 8 patients on tocilizumab (28.8%), 10 patients on infliximab (32.25%), 5 patients on adalimumab (16.12%)), 4 patients under golimumab (12.90%), 1 under secukinumab (3.22%). Biologics were associated with conventional synthetic disease-modifying antirheumatic drugs in 38.7% (methotrexate 12.9%, salosopyrine25, 8%), corticosteroids in 25.7%, non-steroidal anti-inflammatory drugs in 16.1%. The disease activity before COVID-19 of the patients was: 48.39% weak activity, 35.4% remission, 16.13% moderate activity. No patient reported a flare of the disease. During lockdown, 5 patients reported a flare of their disease (16.12%) They were followed for: 2 spondyloarthritis, 1 rheumatoid arthritis, 1 psoriatic arthritis, 1 adult onset Still’s disease. All the patients have temporarily stopped their drugs because they couldn’t come to their appointments because of the lockdown.Conclusion:Our study notes that the patients who kept their follow-up during lockdown have maintained a control of their disease activity. Our results are consistent with the observations of a French study on the impact of lockdown on the activity of rheumatoid arthritis. However, those who couldn’t come to their control appointment due to the lockdown had a flare of their disease. This study remains limited due to the monocentric nature and the small size of our sample.Disclosure of Interests:None declared

scholarly journals POS1234 IMPACT OF THE CHANGE IN ADMINISTRATION ROUTE OF TOCILIZUMAB AND ABATACEPT, DUE TO THE COVID-19 LOCKDOWN ON DISEASE ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 900.1-900
Author(s):  
L. Diebold ◽  
T. Wirth ◽  
V. Pradel ◽  
N. Balandraud ◽  
E. Fockens ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Physical Activity ◽  
Disease Activity ◽  
Univariate Analysis ◽  
Route Of Administration ◽  
Anxiety And Depression ◽  
Administration Route ◽  
Factors Associated ◽  
The Impact

Background:Among therapeutics used to treat rheumatoid arthritis (RA), Tocilizumab (TCZ) and Abatacept (ABA) are both biologic agents that can be delivered subcutaneously (SC) or intravenously (IV). During the first COVID-19 lockdown in France, all patients treated with IV TCZ or IV ABA were offered the option to switch to SC administration.Objectives:The primary aim was to assess the impact of changing the route of administration on the disease activity. The second aim was to assess whether the return to IV route at the patient’s request was associated with disease activity variation, flares, anxiety, depression and low physical activity during the lockdown.Methods:We conducted a prospective monocentric observational study. Eligibility criteria: Adult ≥ 18 years old, RA treated with IV TCZ or IV ABA with a stable dose ≥3 months, change in administration route (from IV to SC) between March 16, 2020, and April 17, 2020. The following data were collected at baseline and 6 months later (M6): demographics, RA characteristics, treatment, history of previous SC treatment, disease activity (DAS28), self-administered questionnaires on flares, RA life repercussions, physical activity, anxiety and depression (FLARE, RAID, Ricci &Gagnon, HAD).The primary outcome was the proportion of patients with a DAS28 variation>1.2 at M6. Analyses: Chi2-test for quantitative variables and Mann-Whitney test for qualitative variables. Factors associated with return to IV route identification was performed with univariate and multivariate analysis.Results:Among the 84 patients who were offered to switch their treatment route of administration, 13 refused to change their treatment. Among the 71 who switched (48 TCZ, 23 ABA), 58 had a M6 follow-up visit (13 lost of follow-up) and DAS28 was available for 49 patients at M6. Main baseline characteristics: female 81%, mean age 62.7, mean disease duration: 16.0, ACPA positive: 72.4%, mean DAS28: 2.01, previously treated with SC TCZ or ABA: 17%.At M6, the mean DAS28 variation was 0.18 ± 0.15. Ten (12.2%) patients had a DAS28 worsening>1.2 (ABA: 5/17 [29.4%] and TCZ: 5/32 [15.6%], p= 0.152) and 19 patients (32.8%) had a DAS28 worsening>0.6 (ABA: 11/17 [64.7%] and TCZ: 8/32 [25.0%], p= 0.007).At M6, 41 patients (77.4%) were back to IV route (26 TCZ, 15 ABA) at their request. The proportion of patients with a DAS28 worsening>1.2 and>0.6 in the groups return to IV versus SC maintenance were 22.5%, 42.5% versus 11.1% and 22.2% (p=0.4), respectively. The univariate analysis identified the following factors associated with the return to IV route: HAD depression score (12 vs 41, p=0.009), HAS anxiety score (12 vs 41, p=0.047) and corticosteroid use (70% vs 100%, p=0.021), in the SC maintenance vs return to IV, respectively.Conclusion:The change of administration route of TCZ and ABA during the first COVID-19 lockdown was infrequently associated with a worsening of RA disease. However, the great majority of the patients (77.4%) request to return to IV route, even without disease activity worsening. This nocebo effect was associated with higher anxiety and depression scores.Disclosure of Interests:None declared

scholarly journals AB0143 THE EFFECT OF RHEUMATOID ARTHRITIS AND SPONDILOARTHRITIS ON PREGNANCY: A LONGITUDINAL RETROSPECTIVE COHORT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1099.1-1099
Author(s):  
F. Pistillo ◽  
A. La Rosa ◽  
P. De Sandre ◽  
E. Fracassi ◽  
G. Scanelli ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Pregnancy Outcome ◽  
Congenital Malformation ◽  
Drug Exposure ◽  
Neonatal Outcome ◽  
Demographic Data ◽  
Moderate Activity ◽  
Moderate Disease ◽  
Rheumatology Unit

Background:Many patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA) are in their childbearing years. Concerns exist regarding the interplay between the rheumatic diseases and the pregnancy (1).Objectives:Actually, there are contradictory data regarding the pregnancy outcome in patients with RA and SpA (2). Thus, we performed this longitudinal retrospective study to evaluate the effect of RA and SpA on pregnancy outcome.Methods:The data of 78 pregnancies of 60 women followed from April 2017 to December 2020 at pregnancy clinic of Internal Medicine Unit, San Bortolo Hospital, Vicenza and Rheumatology Unit, University of Verona were reviewed. Fifty (64.1%) women were affected by RA and 28 (35.9%) by SpA. Information regarding demographic data, disease activity, drug exposure and maternal/foetal outcomes were collected in an electronic database. Details concerning pregnancy complications and congenital malformation were also collected. We compared pregnancy and foetal/neonatal outcome, medication use and disease activity between women affected by RA and SpA. Moreover, we evaluated the effect of disease activity on pregnancy outcome.Results:Overall, there were 70 (86.4%) live births, 10 (12.3%) miscarriages and 1 (1.2%) foetal death. There were three twin pregnancies. Even there was a higher rate of glucocorticoids and bDMARDs use in RA than in SpA group, respectively 40% vs 21% and 70% vs 57,1%, there were no statistical differences regarding drug exposure at conception. Moreover, there were no differences concerning disease activity at conception. Still, a higher rate of glucocorticoids and bDMARDs, respectively 26% vs 10.7% and 46% vs 39.3% were used in RA than in SpA patients during pregnancy. Furthermore, we did not find any statistical differences regarding maternal and foetal/neonatal outcome between pregnancies in the RA and those in the SpA groups. There were four (4.9%), congenital malformation, two (3.8%) in RA group and two (6.9%) in SpA group. About one-third of patients 24 (30.7%) presented a moderate disease activity at conception as evaluated by DAS28PCR and BASDAI. However, there were no significant differences, on maternal and foetal/neonatal outcome in patients with moderate activity disease with respect of those in clinical remission.Conclusion:Even a higher rate of glucocorticoids and bDMARDs were used in RA than in SpA patients, there was no differences on pregnancy outcome between them.References:[1]Ostensen M. Nat Rev Rheumatol. 2017;13:485-493. doi: 10.1038/nrrheum.2017.102.[2]Polachek et al. J Rheumatol 2020;47:161-163. doi: 10.3899/jrheum.190631.Disclosure of Interests:None declared

scholarly journals AB0115 COMPARISON OF ULTRASOUND FINDINGS BETWEEN TNF INHIBITORS AND NON-TNF INHIBITORS AT FIRST BIOLOGICS IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1086.2-1087
Author(s):  
T. Okano ◽  
T. Koike ◽  
K. Inui ◽  
K. Mamoto ◽  
Y. Yamada ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Power Doppler ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Significant Difference ◽  
The Us ◽  
Us Findings ◽  
Improvement Ratio

Background:In rheumatoid arthritis (RA), biologics treatment is one of the effective treatment options. Usually, there is no difference in therapeutic effect regardless of which biologics is used, but the effect for joint synovitis is unknown. Recently, ultrasound (US) has played a role of sensitive imaging modality in the diagnosis and follow-up of patients with RA.Objectives:The aim of this study was to compare the improvement of US findings between TNF inhibitors and non-TNF inhibitors at first biologics in patients with RA.Methods:Fifty-four RA patients who started the first biologics from September 2016 to December 2018 were included in this longitudinal study (SPEEDY study, UMIN000028260). All the patients were performed clinical examination, blood test and US examination at baseline, 4, 12, 24, 36 and 52 weeks. A US examination was performed at the bilateral first to fifth metacarpophalangeal (MCP) joints, first interphalangeal (IP) and second to fifth proximal interphalangeal (PIP) joints, wrist joints (three part of radial, medial and ulnar) and first to fifth metatarsophalangeal (MTP) joints, by using HI VISION Ascendus (Hitachi Medical Corporation, Japan) with a multifrequency linear transducer (18-6 MHz). The gray scale (GS) and power Doppler (PD) findings were assessed by the semi-quantitative method (0-3). GS score and PD score (both 0-108 points) were defined as the sum of each score. The change of disease activity and US findings were compared between TNF group and non-TNF group.Results:Among 54 cases, 32 patients were used TNF inhibitor and 22 were non-TNF inhibitor. Age and duration of RA were significantly higher in the non-TNF group, and MTX dose was significantly lower in the non-TNF group. The baseline inflammatory markers tended to be higher in the non-TNF group and the disease activity was also higher in the non-TNF group. However, the US findings showed no significant difference in both GS and PD between two groups at baseline. US improvement ratio was no difference between TNF group and non-TNF group at 4, 12, 24, 36 and 52 weeks in both GS and PD score. Regardless of the type of biologics, patients with long-term disease duration tended to have poor improvement in US synovial fingings.Table 1.Baseline patient and disease characteristicsTNF (n=32)non-TNF (n=22)P valueFemale patients, n (%)21 (65.6)16 (72.7)0.767Age (years)63.5±15.471.0±9.00.030Disease duration (years)6.5±8.213.0±11.70.032CRP (mg/dl)1.8±2.53.0±3.20.170DAS28-ESR5.0±1.45.8±1.20.022GS score26.1±18.831.8±21.10.313PD score17.6±11.423.1±14.60.150Figure 1.GS and PD improvement ratio at 4, 12, 24, 36 and 52 weeksConclusion:There was no difference in the US findings improvement between patients with TNF inhibitor and non-TNF inhibitor at first biologics in patients with RA.References:[1]Grassi W, Okano T, Di Geso L, Filippucci E. Imaging in rheumatoid arthritis: options, uses and optimization. Expert Rev Clin Immunol. 2015;11:1131-46.[2]Nishino A, Kawashiri SY, Koga T, et al. Ultrasonographic Efficacy of Biologic andTargeted Synthetic Disease-ModifyingAntirheumatic Drug Therapy in RheumatoidArthritis From a Multicenter RheumatoidArthritis Ultrasound Prospective Cohort in Japan. Arthritis Care Res (Hoboken). 2018;70:1719-26.Acknowledgements:We wish to thank Atsuko Kamiyama, Tomoko Nakatsuka for clinical assistant, Setsuko Takeda, Emi Yamashita, Yuko Yoshida, Rika Morinaka, Hatsue Ueda and Tomomi Iwahashi for their special efforts as a sonographer and collecting data.Disclosure of Interests:None declared

scholarly journals POS0492 A MOLECULAR SIGNATURE RESPONSE CLASSIFIER PREDICTS THE LIKELIHOOD OF EULAR NON-RESPONSE TO TNF INHIBITOR THERAPIES IN RA: RESULTS FROM A RETROSPECTIVE COHORT ANALYSIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 478.2-479
Author(s):  
L. Zhang ◽  
C. van der Tog ◽  
A. den Broeder ◽  
T. Mellors ◽  
E. Connolly-Strong ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Predictive Value ◽  
Molecular Signature ◽  
Response Criteria ◽  
Treat To Target ◽  
Inadequate Response ◽  
Tnf Inhibitor ◽  
Target Setting ◽  
The Impact

Background:Following RA treatment recommendations, most people with rheumatoid arthritis (RA) begin targeted therapy with TNF inhibitors (TNFi), even though inadequate response to TNFi therapies is widespread. Treatment changes from one medication to the next are currently fueled by disease-activity measures and eventually result in disease control for most patients; however, this “trial-and-error” approach wastes precious time on ineffective treatments. A delay in reaching treat-to-target goals has a negative effect on patient burden and, possibly, disease progression.1 Useful predictors for TNFi response have been challenging to identify but a specific molecular signature response classifier (MSRC) test was shown to be predictive for inadequate response to TNFi therapies.2 The impact of such identification has the potential to result in improved patient outcomes, but further validation would be welcome, especially for response criteria other than ACR50, and in a stringent treat-to-target setting with lower baseline disease activity.Objectives:To validate the predictive value of the MSRC test in identifying those patients who do not meet EULAR good response criteria after 6 months of TNFi treatment.Methods:Data from a prospective cohort study conducted in the Sint Maartenskliniek (Nijmegen, the Netherlands) of RA patients who started adalimumab or etanercept TNFi as their first biologic were included.3 Baseline RNA samples and clinical assessments were used to identify patients who had a molecular signature1 of non-response to TNFi therapy. Outcomes were calculated at six months using DAS28-CRP-based EULAR good response, and high and low confidence responders and non-responders were identified using Monte Carlo simulation with 2,000 repeats and 70% precision cut off. Outcome measurements were blinded for test results. Treatment switch before 6 months was imputed as non-response. Odds ratios and area under the ROC curve (AUC) assessments were used to evaluate the ability of the MSRC test to predict inadequate response at 6 months against EULAR good response criteria.Results:A total of 68 out of 88 RA patients were identified to have a high-confidence response status and were included in analyses (Table 1). EULAR good response was observed in 45.5% (31/68) of patients. Patients were stratified according to detection of a molecular signature of non-response with an AUC of 0.61. The odds that a patient with the molecular signature of non-response at baseline failed to achieve a EULAR good response at 6 months was four times greater than that of a patient lacking the molecular signature (odds ratio 4.0, 95% confidence interval 1.2-13.3).Table 1.Patient demographicsCharacteristicRA patients (N = 68)Age, median (SD)57 (11)Female, n (%)43 (63.2)CCP positive, n (%)34 (50.0)RF positive, n (%)38 (55.9)Prescribed adalimumab at baseline, n (%)11 (16.2)Prescribed etanercept at baseline, n (%)57 (83.8)Conclusion:In this validation study, the molecular signature of non-response identified patients who did not fulfill the EULAR good response criteria to TNFi therapies. The patient selection process for this study had limitations; additional analysis in an alternative cohort would further verify the performance of the MSRC test. Nevertheless, the test, previously validated for ACR50, now has been validated using EULAR good response in a treat-to-target setting.References:[1]Schipper LG et al, Time to achieve remission determines time to be in remission. Arthritis Res Ther 201[2]Mellors T, et al. Clinical Validation of a Blood-Based Predictive Test for Stratification of Response to Tumor Necrosis Factor Inhibitor Therapies in Rheumatoid Arthritis Patients. Network and Systems Medicine 2020[3]Tweehuysen L et al. Predictive value of ex-vivo drug-inhibited cytokine production for clinical response to biologic DMARD therapy in rheumatoid arthritis. Clin Exp Rheumatol 2019Disclosure of Interests:Lixia Zhang Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Celeste van der Tog: None declared, Alfons den Broeder Consultant of: Abbvie, Amgen, Cellgene, Roche, Biogen, Lilly, Novartis, Celltrion Sanofi, Gilead., Grant/research support from: Abbvie, Amgen, Cellgene, Roche, Biogen, Lilly, Novartis, Celltrion Sanofi, Gilead., Ted Mellors Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Erin Connolly-Strong Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Johanna Withers Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Alex Jones Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Viatcheslav Akmaev Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation

Sign in / Sign up

Export Citation Format

Share Document