scholarly journals Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study

2018 ◽  
Vol 77 (9) ◽  
pp. 1295-1302 ◽  
Author(s):  
Dominique Baeten ◽  
Mikkel Østergaard ◽  
James Cheng-Chung Wei ◽  
Joachim Sieper ◽  
Pentti Järvinen ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Primary Endpoint ◽  
Activity Index ◽  
Study Drug ◽  
Disease Activity Index ◽  
Dose Finding ◽  
Double Blind ◽  
Registration Number ◽  
Activity Index Score ◽  
Interleukin 23

ObjectivesTo evaluate the efficacy and safety of risankizumab, a humanised monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), in patients with active ankylosing spondylitis (AS).MethodsA total of 159 patients with biological-naïve AS, with active disease (Bath Ankylosing Spondylitis Disease Activity Index score of ≥4), were randomised (1:1:1:1) to risankizumab (18 mg single dose, 90 mg or 180 mg at day 1 and weeks 8, 16 and 24) or placebo over a 24-week blinded period. The primary outcome was a 40% improvement in Assessment in Spondylo Arthritis International Society (ASAS40) at week 12. Safety was assessed in patients who received at least one dose of study drug.ResultsAt week 12, ASAS40 response rates were 25.5%, 20.5% and 15.0% in the 18 mg, 90 mg and 180 mg risankizumab groups, respectively, compared with 17.5% in the placebo group. The estimated difference in proportion between the 180 mg risankizumab and placebo groups (primary endpoint) was –2.5% (95% CI –21.8 to 17.0; p=0.42). Rates of adverse events were similar in all treatment groups.ConclusionsTreatment with risankizumab did not meet the study primary endpoint and showed no evidence of clinically meaningful improvements compared with placebo in patients with active AS, suggesting that IL-23 may not be a relevant driver of disease pathogenesis and symptoms in AS.Trial registration numberNCT02047110; Pre-results.

Association of IL-12B Genetic Polymorphism with the Susceptibility and Disease Severity of Ankylosing Spondylitis

2011 ◽  
Vol 39 (1) ◽  
pp. 135-140 ◽  
Author(s):  
RUEY-HONG WONG ◽  
JAMES CHENG-CHUNG WEI ◽  
CHUN-HUANG HUANG ◽  
HONG-SHEN LEE ◽  
SHANG-YAN CHIOU ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Severity ◽  
Activity Index ◽  
Disease Activity Index ◽  
T Helper 17 ◽  
Tyrosine Kinase 2 ◽  
Polymerase Chain ◽  
Activity Index Score ◽  
Interleukin 23

Objective.Interleukin 23 (IL-23) stimulates the differentiation of T helper 17 (Th17) cells, which are involved in the pathogenesis of ankylosing spondylitis (AS). Binding of IL-23 to the IL-23 receptor complex activates Janus kinases 2 and tyrosine kinase 2, which phosphorylate IL-23R and subsequently promote the transcription of the IL-17 gene. IL-12B encodes a p40 subunit common to IL-12 and IL-23. We evaluated the effects of IL-12B and IL-23R genotype on the occurrence and clinical features of AS.Methods.A total of 362 patients with AS and 362 healthy controls were enrolled in the study. Genotypes of IL-12B A1188C (rs3212227) and IL-23R C2370A (rs10889677) were identified by polymerase chain reaction/restriction fragment-length polymorphism. Disease activity and functional status were assessed by Bath AS indices.Results.Subjects carrying IL-12B CC [matched relative risk (RRm) 1.93, 95% CI 1.23–3.03] and IL-12B AC (RRm 1.73, 95% CI 1.21–2.46) genotypes had a significantly greater risk of developing AS than subjects with the IL-12B AA genotype. Subjects carrying both IL-12B CC and IL-23R AA genotypes also had a significantly higher risk (RRm 2.98, 95% CI 1.51–5.89) of developing AS compared to those with IL-12B AA and IL-23R CC/CA genotypes, and this interaction between IL-12B and IL-23R was significant. Patients with AS who had IL-12B CC and IL-12B AC genotypes had an obviously increased Bath Ankylosing Spondylitis Disease Activity Index score compared to those who carried the IL-12B AA genotype (4.3 vs 3.7).Conclusion.The IL-12B A1188C genotype was associated with the development and disease severity of AS.

Effects of Homoeopathic Single and Minimum Dose on Non-Radiographic Axial Spondyloarthritis—BASDAI Assessment

2020 ◽  
Vol 33 (01) ◽  
pp. 041-052
Author(s):  
Deepak Kumar ◽  
Eiphrangdaka L. Suchiang ◽  
Gautam Pal
Keyword(s):  
Ankylosing Spondylitis ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Low Back ◽  
Beneficial Effects ◽  
Mild Disease ◽  
Minimum Dose ◽  
Before And After ◽  
Activity Index Score

AbstractEarly cases of ankylosing spondylitis do not have the typical presentation of radiographic sacroiliitis but present as non-radiographic axial spondyloarthritis (nr-axSpA) where both are varieties of axSpA. Homoeopathic prescription based on totality of symptoms offers a promising relief to nr-axSpA where peripheral joints are also affected. Here, a 27-year-old male patient presented with bilateral heel pain, pain in low back, pain on base of right toes, pain in neck with stiffness for 1 year had refractive response to conventional medication. Diagnosis was confirmed by Assessment of SpondyloArthritis International Society diagnostic criteria for axSpA. Single medicine and minimum dose of Silicea showed its effectiveness on the symptoms' improvement and Bath Ankylosing Spondylitis Disease Activity Index score whereby score of 8.8 (active disease) before treatment changed to 1.2 (inactive or mild disease) after treatment. Various other parameters were assessed accordingly before and after treatment. This case report encourages further exploring the beneficial effects of homoeopathic treatment in clinical condition like axSpA utilising validated scale.

Efficacy of TNFα blockers in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysis

2014 ◽  
Vol 74 (6) ◽  
pp. 1241-1248 ◽  
Author(s):  
Johanna Callhoff ◽  
Joachim Sieper ◽  
Anja Weiß ◽  
Angela Zink ◽  
Joachim Listing
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Effect Size ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Meta Analysis ◽  
Disease Activity Index ◽  
Effect Sizes ◽  
Double Blind ◽  
Mixed Effect

ObjectivesThis meta-analysis investigates the efficacy of tumour necrosis factor α (TNFα) blockers versus placebo for the treatment of ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).MethodsA systematic literature search was conducted independently by two reviewers. Double-blind randomised controlled trials (RCTs) investigating the efficacy of adalimumab, certolizumab, etanercept, golimumab or infliximab in approved dosages in comparison with placebo were included. The use of concomitant non-steroidal antirheumatic drugs was allowed. The outcome parameters were improvement in disease activity and function measured by the Bath AS disease activity index (BASDAI), Bath AS functional index (BASFI) and ASAS40 response. The effect sizes of the changes in BASDAI/BASFI between TNFα blocker and placebo comparator groups were calculated. Mixed effect models were applied separately for RCTs with AS and nr-axSpA patients and differences between those groups were evaluated in a joint model.Results20 studies with data from 3096 patients were included in the analysis: 15 studies with AS patients, four with nr-axSpA patients and one with both. For AS patients, TNFα blockers showed better efficacy than placebo for BASDAI (effect size 1.00), BASFI (effect size 0.67) and ASAS40 response (OR 4.7). For nr-axSpA patients, the differences were smaller (effect sizes 0.73, 0.57; OR 3.6). However, after adjustment for the year of publication as a proxy for disease severity, no differences in the effect sizes between the AS and nr-axSpA trials were observed.ConclusionsCompared with placebo, TNFα blockers improve disease activity and functional capacity clinically meaningful for both AS and nr-axSpA patients.

scholarly journals Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial

2021 ◽  
pp. annrheumdis-2021-221019
Author(s):  
Lars Erik Kristensen ◽  
Mauro Keiserman ◽  
Kim Papp ◽  
Leslie McCasland ◽  
Douglas White ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Primary Endpoint ◽  
Study Drug ◽  
Signs And Symptoms ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
American College Of Rheumatology ◽  
Interleukin 23

ObjectiveTo evaluate risankizumab, a biological therapy that inhibits interleukin 23, in patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD).MethodsIn the randomised, placebo-controlled, double-blind KEEPsAKE 1 trial, 964 patients with active PsA were randomised (1:1) to receive risankizumab 150 mg or placebo at weeks 0, 4 and 16. The primary endpoint was the proportion of patients achieving ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Here, we report the results from the 24-week double-blind period; the open-label period with all patients receiving risankizumab is ongoing.ResultsAt week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (57.3% vs placebo, 33.5%; p<0.001). Significant differences were also observed for risankizumab versus placebo for the first eight ranked secondary endpoints, including skin and nail psoriasis endpoints, minimal disease activity and resolution of enthesitis and dactylitis (p<0.001). Adverse events and serious adverse events were reported at similar rates in the risankizumab and placebo groups. Serious infections were reported for 1.0% and 1.2% of patients receiving risankizumab and placebo, respectively. There was one death in the risankizumab group (urosepsis deemed unrelated to the study drug).ConclusionsRisankizumab treatment results in significantly greater improvement of signs and symptoms of PsA compared with placebo and is well tolerated in patients with active PsA who have responded inadequately or are intolerant to ≥1 csDMARD.Trial registration numberNCT03675308.

scholarly journals Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study

2017 ◽  
Vol 45 (3) ◽  
pp. 341-348 ◽  
Author(s):  
Atul Deodhar ◽  
John D. Reveille ◽  
Diane D. Harrison ◽  
Lilianne Kim ◽  
Kim Hung Lo ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Activity Index ◽  
Controlled Trial ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Link Type ◽  
Secondary Endpoints

Objective.To evaluate the safety and efficacy of intravenous golimumab (GOL) in patients with active ankylosing spondylitis (AS).Methods.In a phase III, randomized, double-blind, placebo (PBO)-controlled trial, 208 patients were randomized (1:1) to intravenous (IV) infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, 12, and every 8 weeks, or PBO (n = 103) at weeks 0, 4, and 12, with crossover to GOL at Week 16. The primary endpoint was ≥ 20% improvement from baseline in the Assessment of Spondyloarthritis International Society Criteria (ASAS20) at Week 16. Secondary endpoints included ASAS40, ≥ 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), and change in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16. Safety was monitored through Week 28.Results.Significantly greater proportions of GOL-treated patients had ASAS20 response at Week 2 (37.1% vs 19.4%; p = 0.005) and at Week 16 (73.3% vs 26.2%; p < 0.001). At Week 16, 41.0% of those receiving GOL achieved BASDAI50 compared with 14.6% of those taking PBO (p < 0.001), and the GOL group had greater mean improvement in BASFI (−2.4 vs −0.5; p < 0.001). Through Week 16, 23.3% of patients in the PBO group and 32.4% of patients in the GOL group had ≥ 1 adverse event (AE); infections being the commonest type of AE. Through Week 28, two GOL-treated patients had a serious AE.Conclusion.GOL 2 mg/kg administered IV at weeks 0, 4, and every 8 weeks significantly reduced the signs and symptoms of AS in adults. AE were consistent with other antitumor necrosis factor therapies, with no new safety signals (Clinicaltrials.gov: NCT02186873).

scholarly journals AB0840 DIAGNOSIS VALUE OF INTERLEUKIN 23 IN SPONDYLOARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1443.3-1444
Author(s):  
L. Kharrat ◽  
M. Slouma ◽  
A. Tezeghdenti ◽  
W. Dkhili ◽  
R. Dhahri ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Enzyme Linked Immunosorbent Assay ◽  
Healthy Controls ◽  
Reactive Protein ◽  
Asas Criteria ◽  
The Mean ◽  
Interleukin 23

Background:Interleukin 23 (IL-23) is a pivotal pro-inflammatory cytokine in the Th17/IL-23 axis which became the center of attention in researches during these last decades, especially during spondyloarthritis (1).Objectives:We aimed to study the diagnosis value of IL-23 serum in spondyloarthritis.Methods:We conducted a case-control study, including 144 subjects divided into 2 groups:-G1: 72 patients meeting the Assessment of SpondyloArthritis International Society (ASAS) criteria for spondyloarthritis (SA)-G2: 72 healthy controls matched for age and sex.For each SA patient we collected the following parameters: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), ASDAS (Ankylosing Spondylitis Disease Activity Score), BASFI (Bath Ankylosing Spondylitis Functional Index), and BASRI (Bath Ankylosing Spondylitis Radiology Index).The IL-23 level was measured using Enzyme-linked immunosorbent assay (ELISA).Erythrocyte Sedimentation rate (ESR) and C-reactive protein (CRP) were also measured.We performed a ROC analysis and computed the air under the curve (AUC) at IL-23 to diagnose SA patients.Statistical analysis was performed using “IBM SPSS Statistics” software version 25.Results:The study included 57 men and 15 women. The mean age was 44.84 ± 13.42 years. The mean age at the onset of the disease was 35.97 ± 12.88 years. The disease duration was 8.54 ± 7.7 years.Seventy-nine per cent of our patients had axial radiographic spondyloarthritis (n=57). Peripheral involvement was found in 45.8% (n=33). Eighteen patients had both axial and peripheral involvement concomitantly. Psoriasis was found in 36.1% of the cases (n=26).The mean BASDAI and ASDAS-CRP were 3.21 ± 1.64 and 3.05 ± 1.51, respectively.The mean was BASFI 3.88 ± 2.69. The mean was BASRI 5.26 ± 4.14.The mean ESR and CRP were 36.74 ± 29.38 mm/hr and 20.45 ± 25.19 mg/dL, respectively.IL-23 level was significantly higher in patients compared to healthy controls (23.1 ± 2.72 pg/mL and 5.02 ± 0.59 pg/mL, respectively, p<0.0001).As shown in Figure 1, the AUC value to distinguish between spondyloarthritis and healthy control was 0.705 (p<0.0001). IL-23 cut-off was 7.96 pg/mL (Sensibility= 69.4%, specificity=98.6%).Figure 1.AUC at IL-23 between SA patients 0.705 (p<0.0001) Nevertheless, no correlation was found between serum IL-23 levels and the following parameters: ESR, CRP, BASDAI, ASDAS-CRP, BASFI and BASRI.Conclusion:As reported to previous studies, our study showed that IL-23 is significantly higher in SA patients (2).Interestingly, IL-23 was able to distinguish between SA patients and healthy controls with a cut-off of 7.96 pg/mL. This finding suggests that IL-23 may be practical for the diagnosis of SA.References:[1]K V, D E. IL-23 Responsive Innate-Like T Cells in Spondyloarthritis: The Less Frequent They Are, the More Vital They Appear [Internet]. Vol. 17, Current rheumatology reports. Curr Rheumatol Rep; 2015 [cité 13 avr 2020]. Disponible sur: https://pubmed.ncbi.nlm.nih.gov/25874346/[2]Wang X, Lin Z, Wei Q, Jiang Y, Gu J. Expression of IL-23 and IL-17 and effect of IL-23 on IL-17 production in ankylosing spondylitis. Rheumatol Int. sept 2009;29(11):1343-7.Disclosure of Interests:None declared

Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study

2011 ◽  
Vol 70 (6) ◽  
pp. 1108-1110 ◽  
Author(s):  
I-H Song ◽  
F Heldmann ◽  
M Rudwaleit ◽  
H Haibel ◽  
A Weiß ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Pilot Study ◽  
Activity Index ◽  
Disease Activity Index ◽  
Inadequate Response ◽  
Open Label ◽  
Tnfα Inhibitor ◽  
Group 2 ◽  
Activity Index Score ◽  
Group 1

ObjectiveTo prospectively explore the short-term efficacy and safety of abatacept in patients with ankylosing spondylitis (AS).MethodsIn this prospective open-label pilot study, abatacept (10 mg/kg) was administered intravenously on days 1, 15, 29 and every 28 days thereafter up to week 24 in 15 tumour necrosis factor α (TNFα)-inhibitor naive patients (group 1) and 15 patients with inadequate response to TNFα inhibitors (group 2) with active AS. The primary end point was the proportion of patients with 40% improvement according to the Assessment of SpondyloArthritis international Society criteria (ASAS40) in both groups at week 24.ResultsAt week 24, ASAS40 was reached by 13% of group 1 and 0% of group 2; 20% improvement (ASAS20) was reached by 27% and 20%, respectively. There was no significant change of Bath Ankylosing Spondylitis Disease Activity Index score, patient global assessment or C reactive protein. Overall, abatacept was well tolerated.ConclusionsIn this pilot open-label AS study a major response was not observed.

scholarly journals OP0142 NETAKIMAB REDUCES ANKYLOSING SPONDYLITIS ACTIVITY IN PATIENTS WITH OR WITHOUT SACROILIITS ON MRI: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 84.1-84
Author(s):  
I. Gaydukova ◽  
V. Mazurov ◽  
S. Erdes ◽  
T. Dubinina ◽  
A. Kundzer ◽  
...  
Keyword(s):  
New York ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Response ◽  
Activity Index ◽  
Disease Activity Index ◽  
Phase 3 ◽  
Double Blind ◽  
Active Sacroiliitis ◽  
The Difference

Background:The presence of sacroiliitis in patients (pts) with ankylosing spondylitis (AS) on imaging can be established both by sacroiliac joint (SIJ) X-ray or MRI. Active sacroiliitis on MRI as defined by ASAS is predictor of good treatment response to biological disease modifying anti-rheumatic drugs [1, 2]. Netakimab (NTK) is a humanized anti-interleukin-17A antibody approved for the treatment of AS, psoriatic arthritis, moderate-to-severe plaque psoriasis in Russia and Belarus. The difference in treatment response to NTK in AS pts with and without active sacroiliitis on MRI (MRI+/MRI−) is unclear.Objectives:To report the changes in AS activity in pts with and without sacroiliitis on MRI at week 16 of NTK treatment.Methods:ASTERA (NCT03447704) is an ongoing phase 3 placebo (PBO)-controlled clinical study, aimed at evaluating NTK efficacy in AS. All pts fulfilled modified New York criteria. Evaluation of acute inflammation on SIJ MRI was performed at the baseline but was not an inclusion criterion. This analysis includes pts received subcutaneous NTK 120 mg every 2 wks with available baseline SIJ MRI. The presence of sacroiliitis on MRI was defined as SPARCC>2. Efficacy endpoints included ASAS20/40, ASAS partial remission (PR), changes from baseline in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score).Results:67 MRI+ and 46 MRI− pts were included into analysis. Baseline characteristics were balanced across both arms. 42.4% of MRI+ pts and 38.3% of MRI− pts achieved ASAS40 at week 16 (p≥0.05), ASAS20 was observed in 65.2%/55.3% pts in the same arms respectively (p≥0.05). ASAS PR was reported for 15.2% MRI+ and 17.0% MRI− pts (p≥0.05). Improvements in BASDAI and ASDAS-CRP were similar across both arms. At wk 16, mean change from baseline in BASDAI was −2.7 vs −3.0 for MRI+ and MRI− pts respectively, mean change in ASDAS-CRP was −1.7 vs −1.4 in the same arms (p≥0.05 for all), (figure 1).Figure 1.Clinical improvements in AS disease activity. Mean change from baseline is shown for (A) ASDAS-CRP, and (B) BASDAIConclusion:NTK leads to decline of disease activity in AS pts irrespectively of sacroiliitis on MRI.References:[1]Rudwaleit M, et al. MRI in predicting a major clinical response to anti-tumour necrosis factor treatment in ankylosing spondylitis. Ann Rheum Dis. 2008;67(9):1276-81.[2]Sieper J, et al. A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015;67(10):2702-12.Acknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, V Mazurov: None declared, Shandor Erdes: None declared, Tatiana Dubinina: None declared, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Anna Eremeeva Employee of: Biocad

scholarly journals Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial

2020 ◽  
pp. annrheumdis-2020-218808
Author(s):  
Xenofon Baraliakos ◽  
Laure Gossec ◽  
Effie Pournara ◽  
Slawomir Jeka ◽  
Antonio Mera-Varela ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Visual Analogue Score ◽  
Spinal Pain ◽  
Inadequate Response ◽  
Double Blind ◽  
Registration Number ◽  
Axial Disease

ObjectivesMAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA).MethodsThis phase 3b, double-blind, placebo-controlled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12.ResultsPatients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p<0.0001).ConclusionsSecukinumab 300 mg and 150 mg provided significant improvement in signs and symptoms of axial disease compared with placebo in patients with PsA and axial manifestations with inadequate response to NSAIDs.Trial registration numberNCT02721966.

scholarly journals AB0664 DIAGNOSIS DELAY IN ANKYLOSING SPONDYLITIS PATIENTS IN EGYPT: FACTORS, SOCIOECONOMIC AND CLINICAL OUTCOME

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1627.2-1627
Author(s):  
F. I. Abdelrahman ◽  
M. Mortada
Keyword(s):  
Ankylosing Spondylitis ◽  
Social Life ◽  
Activity Index ◽  
Diagnostic Delay ◽  
Disease Activity Index ◽  
Diagnosis Delay ◽  
Functional Index ◽  
Delay In Diagnosis ◽  
Significant Difference ◽  
The Mean

Background:Ankylosing spondylitis (AS) is a destructive inflammatory disease which was reported to have the longest diagnostic delay among the inflammatory rheumatic disease. This lag period have a great impact on the clinical outcome and socioeconomic state of the patients. With the advent of tumor necrosis factor-α (TNF-α) inhibitors, early diagnosis in AS has become important(1).Objectives:to evaluate the period from symptom onset to diagnosis of AS in Egyptian patients and to examine possible reasons for delayed diagnosis and its impact on the economic and social life of the patients.Methods:The study included 87 AS patients diagnosed according to the Assessment of Spondyloarthritis international Society (ASAS) criteria (2). A face-to-face interview was applied to take medical history, and a questionnaire that contains some clinical aspects of disease was used. Diagnosis delay was described as the gap between first AS symptom and correct diagnosis of AS. Clinical and functional assessment of axial SpA measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI). The direct medical cost during years of delay (including costs of medical consultations, medications, investigations, physiotherapy and surgical treatment) had been estimated by Egyptian pound.Results:The study included 87 AS patients with mean age (30.03±8.3), 70 male (80.5%) and 17 female (19.5%).Mean delay in diagnosis was(5.7 ±4.9) years. Mean of diagnostic delay for patient diagnosed before 2010 is (14±4.4) and that of patients diagnosed after 2010 is (3.5±1.8) with significant difference between both (p value<0.0001). The main cause of delay was incorrect diagnosis as follow degenerative disc disease (43/87, 49.4%), non-specific back pain (31/87, 35.6%), rheumatoid arthritis (10/87,11.5%), rheumatic fever (2/87, 2.3%) and tuberculosis of spine (1/87, 1.1%). The mean of the medical visits was (6±5.4). Most incorrect initial diagnoses were made by orthopedicians (57.9%), followed by neurologists (22.2%) followed by rheumatologist (10%) and general phyisicians (9.9%). Absence of extra-articular manifestations, negative family history and juvenile age are significantly associated with diagnostic delay. Delay in diagnosis is significantly associated with higher disease activity index(BASDAI), functional index (BASFI), and damage index(BASMI). The mean of the costs during years of delay is (15671.3±546.1) with the mean of cost per each year delay (660.9±6.6) with high significant association between the cost and longer delay in diagnosis (<0.0001). Regarding work ability, we found that(32.2%) are fit for work, unfit (29.9%), partially fit (37.9%) with high significant difference between ability of work and shorter delay. Regarding social effect, 40.2 % of patients developed negative effect on social life with significant association to diagnostic delay (0.004).Conclusion:Our study confirmed the importance of early diagnosis of AS due to its impact on patient’s health outcome and socioeconomic state.We recommend to increase the awareness about the disease among healthcare professionals in our region.References:[1]Sykes M. et al: Diagnostic delay in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis; Ann Rheum Dis.2015;74:e44.[2]Rudwaleit M. et al: The development of Assessment of Spondyloarthritis international Society classification criteria for axial spondyloarthritis; Ann Rheum Dis, 68 (2009), pp.777-783.Disclosure of Interests:None declared

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