scholarly journals SAT0366 CLINICAL RESPONSE TO BIOLOGIC DMARDS IN AXIAL SPONDYLOARTHRITIS AND AXIAL PSORIATIC ARTHRITIS. DIFFERENT DISEASES, SAME OUTCOMES?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1130.2-1130
Author(s):  
D. Benavent ◽  
C. Plasencia ◽  
K. N. Franco Gomez ◽  
L. Nuño ◽  
A. Balsa ◽  
...  

Background:Patients with psoriatic arthritis may present predominant axial involvement. Currently, it is unclear whether these patients should be considered as axial spondyloarthritis (axSpA) with psoriasis or psoriatic arthritis with axial involvement –also known as axial PsA (axPsA). Data comparing medium-term treatment response to biological drugs in axSpA and axPsA would add relevant information to answer this question.Objectives:To compare the clinical response and predictor factors after one year of biological therapy in patients with axSpA and axPsA.Methods:One-year follow-up data from all patients (pts) with axSpA or axPsA (defined by the treating rheumatologist) included in a prospective cohort of pts receiving biological therapy from la Paz University Hospital between 2002 and 2019 were analysed. Demographic information, laboratory tests, concomitant treatments and disease status were collected at baseline. Clinical disease activity was measured by PhGA and ASDAS criteria at baseline, 6 and 12 months. According to ASDAS, disease activity was defined as: inactive disease (ID) (ASDAS <1.3), low disease activity (LDA) (ASDAS 1.3-2.1), high disease activity (HDA) (ASDAS 2.1-3.5) and very high disease activity (VHDA) (ASDAS >3.5). Clinical important improvement and major improvement were defined by ASDAS (delta-ASDAS ≥ 1.1 and ≥ 2.0, respectively). According to PhGA, disease activity was assorted by consensus of 3 expert rheumatologists in: ID with PhGA<5, LDA with PhGA 5-30, HDA with PhGA >30-60 and VHDA with PhGA >60. Clinical improvement by PhGA was defined as an improvement of 30 % compared to baseline. In the statistical analysis, the frequency of pts achieving each clinical activity status and clinical improvement at 6m and 12m were compared using Fisher test, separately for axSpA and axPsA. Baseline predictor factors for achieving clinical response and clinical improvement were identified using univariable and multivariable binary regression.Results:Out of 352 included pts, 287 (81.5%) had axSpA and 65 (18.5%) axPsA. Sixty percent were males, 158 (45%) smokers, with mean (SD) baseline disease activity of ASDAS (bASDAS): 3.3 (0.9) and PhGA: 39.1 (21.5). Biological therapies initiated included TNF inhibitors in 93.8 % and secukinumab in 6.2%. In comparison to axPsA, pts with axSpA were more HLA B27 positive (p<0.001) and had better PhGA at baseline (p=0.02). They also had more uveitis (p=0.03) and were more radiographically affected (p<0.001).Response rates at 6m and 12m in both diseases according to ASDAS are shown in Figure 1, and to PhGA in Figure 2. Both diseases presented a similar clinical response, and no statistically significant differences were observed for any disease activity interval between them for ASDAS or PhGA. There were no differences between both diseases on clinical improvement, regardless the type of measurement.Figure 1.Response rates (in percentage) by ASDAS at 6m and 12m in axSpA and PsAIn the group of axSpA, the univariate analysis observed that LDA (by ASDAS) at 12m was associated with bASDAS (OR=0.67, p=0.02), male gender (OR=2.8, p=0.001) and HLA B27 positive (OR=2.3, p=0.01). In the multivariate analysis, these variables remained significantly associated with LDA (bASDAS: OR= 0.67; p<0.05; male gender: OR=2.7, p<0.01; and HLA B27 positivity OR=2.6, p<0.01). In the group of axPsA, the univariate analysis showed a tendency that male pts achieved LDA more frequently at 6m (OR=3.0, p=0.05) and at 12m (OR=2.75, p=0.09). In the multivariable analyses, none of the factors was significantly associated neither with clinical improvement nor with LDA in pts with axPsA.Conclusion:In clinical practice, pts with axSpA and axPsA present a similar clinical response to biological therapy within the first year of treatment. Male pts seem to have better medium-term outcomes in both diseases, and HLA B27 pts respond better in axSpA.Disclosure of Interests:Diego Benavent: None declared, Chamaida Plasencia: None declared, Karen Nathalie Franco Gomez: None declared, Laura Nuño: None declared, Alejandro Balsa Grant/research support from: BMS, Roche, Consultant of: AbbVie, Gilead, Lilly, Pfizer, UCB, Sanofi, Sandoz, Speakers bureau: AbbVie, Lilly, Sanofi, Novartis, Pfizer, UCB, Roche, Nordic, Sandoz, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1666-1667
Author(s):  
D. Benavent ◽  
V. Navarro-Compán ◽  
I. Monjo ◽  
M. Novella-Navarro ◽  
A. Balsa ◽  
...  

Background:Treatment in Psoriatic Arthritis (PsA) has undergone a major revolution in recent years, with the development of new targets and molecules. Despite these advances, data from clinical practice demonstrating a change in management success are scarce.Objectives:To evaluate if the proportion of patients (pts) with PsA maintaining an acceptable medium-term control of the disease activity after starting a first biologic agent is increasing over time.Methods:Prospective cohort including 101 patients (pts) with PsA starting a 1st biologic (TNF inhibitor, anti-IL 17 inhibitor) in a tertiary hospital between 2002-2018. Demographic, clinical and laboratory data were collected at the beginning of treatment. Disease activity indexes (ASDAS for axPsA and DAPSA for pPsA) were collected before starting biologic, six and twelve months later (baseline, 6m and 12m visit, respectively). Low disease activity (LDA) was defined as ASDAS < 2.1 (axPsA) and DAPSA ≤14 (pPsA). Three groups were established according to biologic initiation date: period 1 (p1) (between 2002-2007), (p2) 2008-2013 and (p3) 2014-2018. Each period had a minimum follow-up of 1 year for every patient. For each interval, the percentage of pts achieving persistent (at both follow-up visits) LDA was determined, as a marker of acceptable medium-term control of the disease. All collected variables were compared between groups by ANOVA and Chi-Squared test.Results:Out of the 101 pts initiating biological therapy, 46 % were males and 57 % had peripheral PsA. At the biologic treatment start, mean ± SD age was 48.5 ± 12 years and disease duration was 9.9 ± 10 years. Biological therapies initiated included etanercept in 38 % of pts, infliximab in 24 %, adalimumab in 25 %, golimumab in 7 %, secukinumab in 3 % and certolizumab in 3 %.Stratified by time intervals, 36 (35.6%) pts started in p1, 36 (35.6%) in p2 and 29 (28.8%) in p3. Baseline characteristics of pts by periods are shown in Table 1. For patients in p3, compared to the previous intervals, a significant lower CRP (p=0.03) and ESR (p=0.004) were found at baseline, whereas there were no significant differences on baseline disease activity indices. Fifty-one (50%) pts achieved persistent-LDA after one year of starting biologic. Figure 1 reports the total number of patients that were in LDA in all the visits in the 1styear, stratified per period of time and predominant manifestation. A lower percentage of patients in LDA (33% in p1 vs, 67% in p2 vs 52% in p3, p = 0.02) was found in the first interval, in comparison to the most recent periods. The difference in response between p2 and p3 is mainly due to the group of patients with pPsA, whereas the improvement in the group of patients with axPsA remains constant in both periods.Table 1.Baseline patient’s characteristics by periods of timeFigure 1.Patients achieving persistent-LDA during the 1styear of biological therapy, stratified by period of time and by disease.* Statistically significant difference with respect to p1.Conclusion:The percentage of pts with PsA achieving LDA status after one year of initiating a biological therapy has substantially increased over time. A lower threshold of inflammation at biological therapy start and a broader spectrum of therapies might explain this better management on PsA.Disclosure of Interests:Diego Benavent: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Irene Monjo: None declared, Marta Novella-Navarro: None declared, Alejandro Balsa Grant/research support from: BMS, Roche, Consultant of: AbbVie, Gilead, Lilly, Pfizer, UCB, Sanofi, Sandoz, Speakers bureau: AbbVie, Lilly, Sanofi, Novartis, Pfizer, UCB, Roche, Nordic, Sandoz, Chamaida Plasencia: None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1630.1-1630
Author(s):  
D. Benavent ◽  
V. Navarro-Compán ◽  
C. Plasencia ◽  
D. Peiteado ◽  
A. Villalva ◽  
...  

Background:Spondyloarthritis (SpA) is a group of heterogeneous diseases that includes axial SpA (axSpA), such as ankylosing spondylitis and axial non-radiographic SpA, and Psoriatic Arthritis (PsA) with peripheral and/or axial involvement (axPsA). Currently, it is not well known if the characteristics and burden of the disease in patients with axPsA are similar to that of patients with axSpA.Objectives:To compare the demographic, clinical and structural features between patients with axSpA and axPsA.Methods:Data from an observational prospective cohort including all patients with SpA initiating biological therapy because of predominant axial manifestations from 2002-2019 in a university hospital were analyzed. AxSpA and axPsA were defined in clinical practice according to the prescribing rheumatologist, based on clinical features and complementary examinations. Demographic information, laboratory tests, disease presentation, sacroiliitis according to modified New York criteria in the pelvis X-ray, disease activity indexes (ASDAS and BASDAI) and concomitant treatment before starting biological drug were collected from the electronic medical record and biologic database. In the statistical analysis, chi square or the exact Fisher’s test was used for categorical and t-student or U-Mann Whitney for continuous variables, according to the distribution of the data. Then, the association between demographic and clinical features and each disease was analysed using univariable and multivariable logistic regression models.Results:Out of 352 included patients, 287 (81.5%) had axSpA, and 65 had axPsA (18.5%). Baseline characteristics are shown in Table 1. Mean baseline ASDAS was 3.3±0.9 and 3.1±1.0 for axSpA and axPsA, respectively. Biological therapies initiated can be seen in Figure 1. No significant differences at baseline were observed between axSpA and axPsA for most of the characteristics including: gender, age at diagnosis, age at starting biologic, disease duration before biologic, smoking habit, CRP, disease activity, enthesitis, dactylitis, inflammatory bowel disease (IBD), patient global assessment and sulfasalazine use. However, there were differences between diseases in some relevant characteristics. AxSpA patients had less peripheral involvement (41.5 vs. 78.5 %, p=0.004), more uveitis (15.3 vs. 3.1 %, p=0.03) and were more frequently HLA-B*27 positive (72.3 vs 34.1 %, p<0.001), in comparison to axPsA patients. They also had better physician global assessments (PhGA) (37.4 vs 44.4, p=0.02), and a higher grade of radiographic sacroiilitis. AxSpA patients used less global baseline concomitant therapy (p=0.001), methotrexate (p<0.001) and prednisone (p<0.01), whereas they used more sulfasalazine (p=0.003) than axPsA patients in our cohort. After running multivariate analyses, the absence of peripheral manifestations (OR=4.7; p<0.001) and the positivity of HLA-B27 (OR=5.4; p<0.001) were independently associated with axSpA.Table 1. Baseline stratified characteristics. Results are shown as absolute numbers (percentages) or mean ± standard deviation.Conclusion:Despite being spondyloartrithis with many common traits, axSpA and axPsA present some differences in clinical practice. Whereas axSpA patients are more frequently HLA-B27 positive, axPsA have more peripheral involvement. These differences in clinical presentation between both diseases may contribute to variances in therapeutic management, such as increased use of baseline concomitant therapy in axPsA patients who initiate biological therapy.Figure 1.Biological therapies initiated in axSpA and axPsADisclosure of Interests:Diego Benavent: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Chamaida Plasencia: None declared, Diana Peiteado: None declared, Alejandro Villalva: None declared, Alejandro Balsa Grant/research support from: BMS, Roche, Consultant of: AbbVie, Gilead, Lilly, Pfizer, UCB, Sanofi, Sandoz, Speakers bureau: AbbVie, Lilly, Sanofi, Novartis, Pfizer, UCB, Roche, Nordic, Sandoz


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 508-508
Author(s):  
M. Moly ◽  
C. Lukas ◽  
J. Morel ◽  
B. Combe ◽  
G. Mouterde

Background:Psoriatic arthritis (PsA) is a heterogeneous disease and its assessment is sometimes difficult. Perception of disease activity by patient and physician is frequently discordant in patients in clinical remission. Ultrasound (US) is an imaging technique, which can detect inflammation in PsA.Objectives:The aim of our study was to assess whether persistence of disease activity evaluated by the patient, considered in remission by his rheumatologist, was associated with inflammation measured by US.Methods:We performed a transversal monocentric study. PsA patients were included if they met the CASPAR criteria and were considered in remission by their rheumatologist. Demographic data, characteristics of the disease and treatments were collected. Discordance was defined by a difference between patient’s and rheumatologist’s global assessment ≥30/100 on a Visual Analogic Scale. An US examination was performed on 50 joints, 28 tendons and 14 entheses by an independent investigator. Synovial or tendon sheath hypertrophy and PD signal were evaluated on a semi-quantitative scale, B Mode and PD signal abnormalities on entheses were searched, according to the EULAR-OMERACT scoring system. US remission was defined by no power Doppler (PD) signal on joints, tendons and entheses and minimal US activity by maximum one PD signal on the same sites. Univariate and multivariate analyses were performed to evaluate factors associated with US abnormalities.Results:Sixty-two PsA patients were included. 40.3% were women, the mean (SD) age was 55 (14) years, 42% were in US remission and 71% in minimal US activity (Table 1), 19.4% had ≥1 PD synovitis and 88.7% had a B mode synovitis, 95.2% had a B mode abnormality on entheses and 51.6% had ≥1 PD signal on entheses. Thirty nine percent had a discordant disease activity assessment with their rheumatologist. In univariate analysis, discordance was not associated with US remission (OR=1.71 (95%CI 0.61-4.83), p=0.224) or US minimal disease activity (OR=0.99 (95%CI 0.32-3.05), p=0.602). In multivariate analysis, US remission was independently associated with female gender (OR=3.94 (95%CI 1.20-12.9), p=0.024) and younger age (OR=0.95 (95%CI 0.91-0.99), p=0.027). Minimal US activity was associated with history of enthesis lesion (OR=11.26 (95%CI 1.34-94.93), p=0.026) and age (OR=0.95 (95%CI 0.90-1), p=0.044).Table 1.Ultrasound characteristics of the 62 PsA patients.N (%)Ultrasound remission26 (41.9)Ultrasound minimal disease activity44 (71)Patients with ≥1 grey scale synovitis55 (88.7)Patients with ≥1 Power Doppler synovitis12 (19.4)Patients with ≥1 grey scale tenosynovitis15 (24.2)Patients with ≥1 Power Doppler tenosynovitis1 (1.6)Patients with ≥1 grey scale enthesitis lesion (thickness, hypo echogenicity, calcification, enthesophyte, erosion, bursitis)59 (95.2)Patients with ≥1 Power Doppler enthesitis32 (51.6)Conclusion:Our study showed persistent inflammation evaluated by US in PsA patients considered in remission by their rheumatologist. However, prevalence of residual inflammation evaluated by US was not higher in patients with self-assessment of their disease discordant from their rheumatologist.Disclosure of Interests:Marie Moly: None declared, Cédric Lukas: None declared, Jacques Morel: None declared, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Gael Mouterde: None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1699.1-1700
Author(s):  
F. Masini ◽  
K. Gjeloshi ◽  
E. Pinotti ◽  
F. Danzo ◽  
F. Guarino ◽  
...  

Background:The association between hyperuricemia and psoriatic arthritis (PsA) is actually generally accepted. Previous studies have demonstrated that uric acid suppress 25(OH)D metabolism [1]. More evidence is required to demonstrate the immune modulatory effects in psoriasis, psoriatic arthritis and other autoimmune diseases. In particular, the potential association between 25-hydroxyvitamin D serum levels and PsA still remains unknown.Objectives:To assess a clinical association between uric acid/25(OH)D serum levels ratio related to PASI, BASDAI and DAPSA, if any, in patients with psoriatic arthritis.Methods:We retrospectively observed 61 patients with psoriatic arthritis referred to our outpatients clinic, independently from already being on therapy or naïve. All selected patients underwent only conventional non-biological therapy at baseline and none received vitamin D supplementation and either allopurinol or febuxostat previously. Blood samples were drawn from all participants for assessment of 25-hydroxyvitamin D and uric acid serum levels. Disease activity of psoriasis and psoriatic arthritis were assessed by the Psoriasis Area and Severity Index (PASI), the Disease Activity Index for Psoriatic Arthritis (DAPSA) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). We assessed the covariates of interest by the Wilcoxon non parametric test, through the SPSS 24 Software.Results:We observed 61 patients, mainly females (83.6%). At the univariate analysis, the uric acid/25(OH)D serum levels ratio revealed significantly associated with DAPSA and BASDAI indexes (p<0.001 and p<0.001, respectively), whilst no significant association emerged with the PASI index (p=0.462).Conclusion:Data in the literature about these associations in the context of psoriatic arthritis are really poor. As a consequence, our findings, though preliminary, suggest us to hypothesize a potential role of uric acid/25(OH)D serum levels ratio as potential inflammation marker in order to better assess the disease activity. However, future larger studies are needed to investigate more in depth this association.[1]Charoenngam N, Ponvilawan B, Ungprasert P. Vitamin D insufficiency and deficiency are associated with a higher level of serum uric acid: A systematic review and meta-analysis. Mod Rheumatol. 2019 Mar 4:1-6.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1161.1-1161
Author(s):  
S. Ganhão ◽  
S. Garcia ◽  
B. M. Fernandes ◽  
M. Rato ◽  
F. Pinheiro ◽  
...  

Background:Psoriatic arthritis (PsA) is an inflammatory arthritis that is characterized by a broad spectrum of clinical conditions, including axial skeletal involvement, enthesitis, dactylitis, uveitis and arthritis. Among those, enthesitis, the inflammation of the junction where the tendon, ligament or joint capsule inserts into the bone, is assigned to be the hallmark, affecting 35–50% of patients. Several clinical methods have been developed to measure it, including The Maastricht AS Enthesitis Score (MASES) index, which tests 13 entheses and the Spondyloarthritis Research Consortium of Canada (SPARCC) index that assesses 16.Objectives:To assess the relationship between enthesitis and clinical response in psoriatic arthritis.Methods:Retrospective study including all the patients with PsA meeting the CASPAR criteria, beginning first-line biologic therapy at our centre. Demographic and clinical data including age, gender, body mass index (BMI), smoking status, physical examination findings such as presence of enthesitis, dactylitis, chronic back pain, tender and swollen joint counts (TJC/ SJC), ESR, CRP, DAS 28 4vESR, BASDAI, BASFI, BASMI, ASDAS, HAQ, patient VAS score, MASES and SPARCC were collected from the Portuguese database Reumapt. Statistical analysis was performed with SPSS. Continuous variables were analysed through Spearman correlations.Results:We included 119 patients with PsA (60 female), of which 14.9% were active smokers. The mean age of patients was 46.3 ± 1.03 years. The median disease duration was 6.8 (0.3-33.8) years and the mean BMI was 26.8 ± 0.5 Kg/m2.Enthesitis, dactylitis, inflammatory back pain, peripheral arthritis, ungueal distrophy, and psoriasis were present in 53 (45.7%), 45 (38.8%), 76 (65.5%), 109 (94%), 45 (38.8%), 104 (89.7%) patients, respectively.At baseline, mean (SD) disease activity parameters were: DAS 28 4vESR 4.9 (0.2), ESR 33.2 (2.3) mm/h; CRP 2.35 (0.3) mg/dL, HAQ 1.3 (0.1), BASDAI 6.6 (0.2), ASDAS 3.9 (0.1), BASMI 3.7 (0.2), BASFI 5.8 (0.3), MASES 1.9 (0.3), SPARCC 2.3 (0.3). Median (min-max) values of TJC, SJC and patient VAS score at baseline were 4 (0-28), 3 (0-19), 76 (0-100), respectively.There were statistically significant positive correlations (0-12 months) between ΔMASES and ΔDAS 28 4vESR (p=0.02, rho=0.432), Δpatient VAS score (p=0.027, rho=0.307), ΔHAQ (p=0.02, rho=0.411), ΔBASDAI (p=0.025, rho=0.326), ΔBASFI (p=0.037, rho=0.315), ΔASDAS (p=0.023, rho= 0.331). Correlations between ΔSPARCC and ΔDAS 28 4vESR (p=0.023, rho=0.332), Δpatient VAS score (p=0.003, rho=0.402), ΔHAQ (p=0.012, rho=0.440), ΔBASDAI (p=0.011, rho=0.368), ΔBASFI (p=0.001, rho=0.445), ΔASDAS (p=0.002, rho= 0.437), ΔCDAI (p=0.039, rho=0.320) and ΔSDAI (p=0.039, rho=0.319), were also significant. However, there weren’t strong correlations between ΔMASES neither ΔSPARCC and PsARC response at 12 months.Conclusion:Our results suggest that enthesitis is correlated with clinical response in PsA, supporting the idea that it is a major determinant of disease activity. It should be given more importance, namely by incorporating it in daily clinical practice, due to its major role, both in establishing an early diagnosis and in assessing treatment response.References:[1]Sunar I, Ataman S, Nas K, Kilic E, Sargin B, Kasman SA, et al. Enthesitis and its relationship with disease activity, functional status, and quality of life in psoriatic arthritis: a multi‑center study. Rheumatol Int. 2019 Nov 26. doi: 10.1007/s00296-019-04480-9.Disclosure of Interests:Sara Ganhão: None declared, Salomé Garcia: None declared, Bruno Miguel Fernandes: None declared, Maria Rato: None declared, Filipe Pinheiro: None declared, Eva Mariz: None declared, Miguel Bernardes Speakers bureau: Abbvie, Amgen, Biogen, Eli-Lilly, Glaxo-Smith-Kline, Pfizer, Janssen, Novartis, Lúcia Costa: None declared


2016 ◽  
Vol 83 (6) ◽  
pp. 721-725 ◽  
Author(s):  
Florenzo Iannone ◽  
Giorgio Carlino ◽  
Antonio Marchesoni ◽  
Piercarlo Sarzi-Puttini ◽  
Roberto Gorla ◽  
...  

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Walter P. Maksymowych ◽  
Thomas Kumke ◽  
Simone E. Auteri ◽  
Bengt Hoepken ◽  
Lars Bauer ◽  
...  

Abstract Background Identification of predictive clinical factors of long-term treatment response may contribute to improved management of non-radiographic axSpA (nr-axSpA) patients. This analysis aims to identify whether any baseline characteristics or Week 12 clinical outcomes in nr-axSpA patients with elevated C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI) enrolled in the C-axSpAnd study are predictive of achieving clinical response after 1 year of certolizumab pegol (CZP). Methods C-axSpAnd (NCT02552212) was a phase 3, multicentre study, including a 52-Week double-blind, placebo-controlled period. Enrolled patients were randomised to CZP 200 mg Q2W or placebo. Predictors of Week 12 (CZP group only) and Week 52 clinical response were identified using a multivariate stepwise logistic regression analysis. Response variables included Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% response (BASDAI50) and ASDAS inactive disease (ASDAS-ID). Predictive factors assessed included demographic and baseline characteristics and clinical outcomes at Week 12. A p-value <0.05 was required for forward selection into the model and p ≥0.1 for backward elimination. Missing data or values collected after switching to open-label treatment were accounted for using non-responder imputation. Sensitivity analyses accounted for patients with changes in non-biologic background medication. Results Of 317 enrolled patients, 159 and 158 were randomised to CZP and placebo, respectively. Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients. Consistent predictors of Week 52 response, measured by ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen (HLA)-B27 positivity and sacroiliitis on MRI at baseline. MRI positivity was also predictive of achieving ASDAS-ID at Week 52. Sensitivity analyses were generally consistent with the primary analysis. In placebo-treated patients, no meaningful predictors of Week 52 response were identified. Conclusions In this 52-Week, placebo-controlled study in nr-axSpA patients with elevated CRP and/or active sacroiliitis on MRI at baseline, MRI sacroiliitis and HLA-B27 positivity, but not elevated CRP or responses at Week 12, were predictive of long-term clinical response to CZP. Findings may support rheumatologists to identify patients suitable for TNFi treatment. Trial registration ClinicalTrials.gov, NCT02552212. Registered on 15 September 2015


RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001149 ◽  
Author(s):  
Philip S Helliwell ◽  
Dafna D Gladman ◽  
Soumya D Chakravarty ◽  
Shelly Kafka ◽  
Chetan S Karyekar ◽  
...  

BackgroundThe interleukin-12/23p40-subunit-inhibitor ustekinumab significantly improved spondylitis-related symptoms through Week 24 in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (PA-PRS) in PSUMMIT-1&2. We further evaluated ustekinumab’s effect on spondylitis-related endpoints in PSUMMIT-1&2 tumour necrosis factor-inhibitor (TNFi)-naïve patients with PA-PRS.MethodsPatients with active PsA (≥5 swollen and ≥5 tender joints, C-reactive-protein ≥ 3.0 mg/L) despite conventional (PSUMMIT-1&2) and/or prior TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45 mg, 90 mg or placebo (Week 0, Week 4, Week 16). Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck/back/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses were assessed at Weeks 12 and 24.ResultsThe pooled PSUMMIT-1&2, TNFi-naïve (n=747), PA-PRS (n=223) subset (158 with human-leucocyte-antigen (HLA)-B27 results) presented with moderate-to-severe spondylitis-related symptoms (mean BASDAI-neck/back/hip pain-6.51, mBASDAI-6.54, BASDAI-6.51, ASDAS-3.81). Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (−1.99 vs −0.18) and mBASDAI (−2.09 vs −0.59). Improvements in neck/back/hip pain and fatigue appeared numerically greater in HLA-B27+ than HLA-B27– patients; those for other domains were generally consistent. Greater proportions of ustekinumab versus placebo-treated patients achieved ASDAS clinically important improvement at Week 24 (decrease ≥ 1.1; 49.6% vs 12.7%; nominal p<0.05).ConclusionsImprovements in BASDAI neck/back/hip pain and mBASDAI among ustekinumab-treated, TNFi-naïve, PsA patients with PA-PRS were clinically meaningful and consistent across assessment tools. Numerically greater improvements in neck/back/hip pain in HLA-B27+ than HLA-B27– patients, noted in the context of similar overall mBASDAI improvements between the subgroups, suggest ustekinumab may improve disease activity in TNFi-naïve PsA patients likely to exhibit axial disease.Clinical trial registration numbersPSUMMIT 1, NCT01009086; PSUMMIT 2, NCT01077362.


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Amani E. Badawi ◽  
Waleed Ali Abou Samra ◽  
Ayman Abd El ghafar

Purpose. To evaluate the effects of preoperative presumed predictor factors on clinical and topographic outcomes in adult keratoconus (KC) 1 year after the standard corneal cross-linking (CXL). Design. Retrospective cohort study. Methods. The study included 84 KC patients (136 eyes) who were treated with conventional CXL. Postoperative best-corrected visual acuity (BCVA) and K max were considered the main predicted variables. The entire participants were divided into subgroups with cutoff values in accordance with the predictive variables. The predicted postoperative outcomes at one year were compared between the subgroups. Next, the predictive variables were analyzed by univariate and multivariate linear regression. Results. In respect to the BCVA, univariate analysis showed that the worse BCVA, the higher K max, and the relative thinner corneas were relatively good predictors of improvement, while multivariate evaluation revealed a strong interrelation with preoperative BCVA only. Regarding the postoperative flattening, univariate analysis found that the cone location and worse preoperative BCVA were the pronounced predictors, whereas the multivariate evaluation focused on the impact of the cone location only. Conclusions. The multivariate analysis disclosed a significant negative association between the baseline BCVA and postoperative BCVA and a positive relationship between the cone eccentricity and postoperative K max.


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