scholarly journals Efficacy of ustekinumab in biologic-naïve patients with psoriatic arthritis by prior treatment exposure and disease duration: data from PSUMMIT 1 and PSUMMIT 2

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e000990 ◽  
Author(s):  
Iain B McInnes ◽  
Soumya D Chakravarty ◽  
Isabel Apaolaza ◽  
Shelly Kafka ◽  
Elizabeth C Hsia ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Duration ◽  
Prior Treatment ◽  
Subcutaneous Injections ◽  
Treatment Groups ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Factor Inhibitor ◽  
Inflammatory Drugs ◽  
Post Hoc

ObjectiveTo evaluate the efficacy of ustekinumab by prior treatment exposure and disease duration in tumour necrosis factor inhibitor (TNF)-naïve patients with psoriatic arthritis (PsA) in the PSUMMIT 1 and PSUMMIT 2 studies.MethodsIn the phase 3, randomised, placebo-controlled PSUMMIT 1 and PSUMMIT 2 studies, adults with active PsA for ≥6 months despite conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or non-steroidal anti-inflammatory drugs (NSAIDs) (PSUMMIT 1) or csDMARDs, NSAIDs and/or anti-TNF agents (PSUMMIT 2) were enrolled. Patients were randomised to subcutaneous injections of placebo, ustekinumab 45 mg or ustekinumab 90 mg at weeks 0 and 4 and every 12 weeks. Efficacy was assessed at week 24 using the American College of Rheumatology criteria and 28-joint count disease activity score using C reactive protein (DAS28-CRP); radiographical progression, enthesitis, and dactylitis were also assessed in this post hoc analysis.ResultsA total of 747 patients were included; all 747 were TNF-naïve, of which, 179 were methotrexate-naïve and TNF-naïve, and 146 were all csDMARD-naïve and TNF-naïve. At week 24, greater proportions of ustekinumab-treated patients had ≥20%/50%/70% improvement in American College of Rheumatology criteria (ACR20/ACR50/ACR70) responses, DAS28-CRP response and DAS28-CRP remission versus placebo in all three prior-treatment populations, with similar differences between treatment groups. Greater proportions of ustekinumab-treated patients also had complete resolution of enthesitis and dactylitis at week 24 across the three prior-treatment populations. Mean changes from baseline in total van der Heijde-Sharp Score at week 24 were generally smaller for ustekinumab-treated patients versus placebo but were statistically significant only in the full TNF-naïve population. Response rates for ACR20/ACR50/ACR70 were similar for TNF-naïve patients with PsA durations of <1 year, ≥1 to <3 years, and ≥3 years.ConclusionUstekinumab-treated patients demonstrated greater clinical response at week 24 compared with placebo regardless of prior treatment exposure and PsA disease duration.

scholarly journals Comparison of Etanercept Monotherapy and Combination Therapy with Methotrexate in Psoriatic Arthritis: Results from 2 Clinical Trials

2016 ◽  
Vol 43 (6) ◽  
pp. 1063-1067 ◽  
Author(s):  
Bernard Combe ◽  
Frank Behrens ◽  
Neil McHugh ◽  
Fiona Brock ◽  
Urs Kerkmann ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Combination Therapy ◽  
Health Assessment ◽  
Severity Index ◽  
Joint Disease ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Psa Response ◽  
Questionnaire Disability

Objective.To evaluate the clinical/functional outcomes associated with etanercept (ETN) monotherapy versus combination therapy in psoriatic arthritis (PsA).Methods.Data from patients with PsA who received ETN alone (n = 322) or combined with methotrexate (MTX; n = 152) for 24 weeks in 2 placebo-controlled clinical trials were summarized across studies.Results.Similar proportions of patients in the monotherapy and combination therapy groups achieved the PsA Response Criteria (80% and 83%) and the American College of Rheumatology improvements of 20% (ACR20; both 70%); numerically higher proportions receiving monotherapy achieved ACR50 (55% vs 48%) and ACR70 (35% vs 27%). Little between-group difference was observed in the 28-joint Disease Activity Score with C-reactive protein, the Psoriasis Area and Severity Index, and the Health Assessment Questionnaire–Disability Index improvement.Conclusion.ETN with and without MTX provided similar benefits in active PsA.

scholarly journals The ratio of measured to estimated glomerular filtration rate may be a marker of early mortality and dialysis requirement

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
James G. Heaf ◽  
Rafal Yahya ◽  
Morten Dahl
Keyword(s):  
Dialysis Initiation ◽  
National Patient Registry ◽  
Treatment Groups ◽  
Reactive Protein ◽  
Ckd Stage ◽  
National Patient ◽  
Highly Correlated ◽  
Post Hoc ◽  
Unplanned Dialysis

Abstract Background It has been suggested that, in patients with CKD stage 5, measured GFR (mGFR), defined as the mean of urea and creatinine clearance, as measured by a 24-h urine collection, is a better measure of renal function than estimated GFR (eGFR), based on the CKD-EPI formula. This could be due to reduced muscle mass in this group. Its use is recommended in the ERBP guidelines. Unplanned dialysis initiation (DI) is associated with increased morbidity, mortality, and reduced modality choice and is generally considered undesirable. We hypothesized that the ratio mGFR/eGFR (M/E) aids prediction of death and DI. Methods All 24-h measurements of urea and creatinine excretion were extracted from the clinical biochemistry databases in Zealand. Data concerning renal diagnosis, comorbidity, biochemistry, medical treatment, mortality and date of DI, were extracted from patient notes, the National Patient Registry and the Danish Nephrology Registry. Patients were included if their eGFR was < 30 ml/min/1.73m2. The last available value for each patient was included. Follow-up was 12 months. Results One thousand two hundred sixty-five patients were included. M/E was median 0.91 ± 0.43. It was highly correlated to previous determinations. It was negatively correlated to eGFR, comorbidity, high age and female sex. It was positively related to albumin and negatively to C-reactive protein. M/E was higher in patients treated with ACE inhibitors and diuretics but no other treatment groups. On a multivariate analysis, M/E was negatively correlated with mortality and combined mortality/DI, but not DI. A post hoc analysis showed a negative correlation to DI at 3 months. For patients with an eGFR 10–15 ml/min/1.73m2, combined mortality and DI at 3 months was for low M/E (< 0.75) 36%, medium (0.75–1.25) 20%, high (> 1.25) 8%. A low M/E predicted increased need for unplanned DI. A supplementary analysis in 519 patients where body surface area values were available, allowing BSA-corrected M/E to be analyzed, revealed similar results. Conclusion A low mGFR/eGFR ratio is associated with comorbidity, malnutrition, and inflammation. It is a marker of early DI, mortality, and unplanned dialysis initiation, independently of eGFR, age and comorbidity. Particular attention paid to patients with a low M/E may lower the incidence of unplanned dialysis requirement.

Biological Therapy for Psoriatic Arthritis in Clinical Practice: Outcomes Up to 2 Years

2010 ◽  
Vol 37 (11) ◽  
pp. 2362-2368 ◽  
Author(s):  
LIISA M. VIRKKI ◽  
BINDU C. SUMATHIKUTTY ◽  
MERJA AARNIO ◽  
HEIKKI VALLEALA ◽  
RIITTA HEIKKILÄ ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Health Assessment ◽  
Routine Care ◽  
Biological Drugs ◽  
Acr20 Response ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Factor Α ◽  
Assessment Questionnaire ◽  
Necrosis Factor

Objective.To evaluate the performance of biological drugs in psoriatic arthritis (PsA) in a routine care setting, using the Finnish national register of biological treatment (ROB-FIN).Methods.Patients with PsA who started therapy with infliximab or etanercept between June 2000 and February 2006 (n = 127) were followed for up to 24 months. Response was evaluated using American College of Rheumatology response criteria including individual measures.Results.Significantly diminished values for swollen and tender joints, patient’s global and pain assessments, doctor’s global assessment of disease activity, erythrocyte sedimentation rate, C-reactive protein, and Health Assessment Questionnaire score were observed within 3 months after commencement of both infliximab and etanercept. Values remained significantly lower throughout the 24 months of followup. ACR20 response at 3 months was 79% (n = 22/28) for infliximab and 76% (n = 34/45) for etanercept. The first biological drug was discontinued in 16% due to lack of effectiveness and in 6% due to adverse events.Conclusion.Anti-tumor necrosis factor-α therapy, often combined with conventional disease-modifying antirheumatic drugs, appeared to have limited toxicity and persistent effectiveness for up to 2 years in a cohort of Finnish patients with severe peripheral PsA.

scholarly journals POS1020 EFFICACY OF TOFACITINIB ON DACTYLITIS IN INDIVIDUAL DIGITS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 777.2-778
Author(s):  
A. M. Orbai ◽  
P. J. Mease ◽  
P. Helliwell ◽  
O. Fitzgerald ◽  
M. Bdewi ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Kinase Inhibitor ◽  
Janus Kinase ◽  
Research Support ◽  
Two Phase ◽  
Janus Kinase Inhibitor ◽  
Treatment Groups ◽  
Link Type ◽  
Hands And Feet ◽  
Post Hoc

Background:Dactylitis, a hallmark of psoriatic arthritis (PsA), is a uniformly diffuse and sometimes painful swelling of the fingers and/or toes.1 Up to 50% of patients (pts) with PsA may experience dactylitis;1,2 as such, dactylitis is an accepted domain of PsA that should be considered in treatment decisions.3 In PsA, dactylitis typically involves feet more than hands; dactylitic joints more frequently have erosive damage, compared with non-dactylitic joints.2 There remains a need for effective therapies to treat dactylitis in pts with PsA. Improvements in dactylitis have been associated with tofacitinib, an oral Janus kinase inhibitor for the treatment of PsA.4,5Objectives:To assess the effect of tofacitinib on dactylitis by location (hands/feet) and individual digit involvement in pts with PsA.Methods:These post hoc analyses used data pooled from two Phase 3 studies (12-month OPAL Broaden [NCT01877668];5 6-month OPAL Beyond [NCT01882439]4) in pts with active PsA treated with tofacitinib 5 mg twice daily (BID; approved dose; to Month [M] 6), tofacitinib 10 mg BID (to M6) or placebo (PBO; to M3); pts were treated continuously with a single conventional synthetic disease-modifying antirheumatic drug. Pts were categorised by the presence of dactylitis at baseline (BL) in the hands and/or feet. Endpoints included change from BL in Dactylitis Severity Score (DSS),6 the number of dactylitic digits and the proportion of pts with dactylitis in individual digits at M1, M3 and M6. Descriptive statistics were generated by visit and treatment arm.Results:Data were pooled from 373 pts with DSS >0 at BL. BL characteristics, including gender, age, race, body mass index, PsA duration, BL DSS and dactylitic digits count were similar across dactylitis groups and treatment groups, except for pts with dactylitis in both the hands and feet, who had higher DSS compared to those with dactylitis in the hands or feet only, likely due to having more dactylitic digits (data not shown). Regardless of location, pts treated with tofacitinib had cumulative improvements from BL to M6 in DSS (Figure 1a) and in the number of dactylitic digits (Figure 1b); improvements in DSS were greater at M1 and M3, compared with PBO. Pts treated with tofacitinib 10 mg BID typically had numerically greater improvements in DSS, compared with pts treated with tofacitinib 5 mg BID (Figure 1a). Most pts treated with tofacitinib experienced improvement of dactylitis across all fingers and toes (Figure 1c–f); mean dactylitis presence was ≤15% at M6 in pts treated with tofacitinib for all digits. Generally, at M1 and M3, fewer pts treated with tofacitinib had dactylitis in any digit, compared with PBO (Figure 1c–f).Conclusion:Among pts with pre-existing dactylitis, treatment with tofacitinib resulted in improvements in dactylitis in hands, feet, or both, and in all digits as early as M1, and up to M6.References:[1]Kaeley et al. Semin Arthritis Rheum 2018; 48: 263-273.[2]Brockbank et al. Ann Rheum Dis 2005; 64: 188-190.[3]Coates et al. Arthritis Rheumatol 2016; 68: 1060-1071.[4]Gladman et al. N Engl J Med 2017; 377: 1525-1536.[5]Mease et al. N Engl J Med 2017; 377: 1537-1550.[6]Helliwell et al. J Rheumatol 2005; 32: 1745-1750.Acknowledgements:Study sponsored by Pfizer Inc. Medical writing support was provided by Eric Comeau, CMC Connect, and funded by Pfizer Inc.Disclosure of Interests:Ana-Maria Orbai Consultant of: Eli Lilly, Novartis, Pfizer Inc, Grant/research support from: AbbVie, Eli Lilly, Horizon, Janssen, Novartis, Philip J Mease Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Genentech, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun, UCB, Philip Helliwell Paid instructor for: Janssen, Novartis, Pfizer Inc, Consultant of: Eli Lilly, Oliver FitzGerald Speakers bureau: AbbVie, Janssen, Pfizer Inc, Consultant of: Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Pfizer Inc, Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis and Pfizer Inc, Mohammed Bdewi Speakers bureau: AbbVie, Pfizer Inc, Dona Fleishaker Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Rajiv Mundayat Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Pamela Young Shareholder of: Pfizer Inc, Employee of: Pfizer Inc.

scholarly journals Persistent eosinophilia and associated organ involvement in Thai patients with systemic sclerosis: Data from the Siriraj scleroderma cohort

2021 ◽  
Vol 36 (4) ◽  
pp. 527-537
Author(s):  
Somsak Punjasamanvong ◽  
Chayawee Muangchan
Keyword(s):  
Systemic Sclerosis ◽  
Disease Duration ◽  
Creatine Phosphokinase ◽  
Total Lung Capacity ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Lung Capacity ◽  
Lower Baseline ◽  
One Year ◽  
Post Hoc

Objectives: This study aims to investigate the prevalence of persistent eosinophilia and associated organ complications in Thai patients with systemic sclerosis (SSc). Patients and methods: This post-hoc study included 107 adult patients (23 males, 84 females; mean age: 50.4±11.6 years; range, 18 to 79 years) diagnosed with SSc between November 2013 and June 2017. Eosinophilia was defined as an absolute eosinophil count of >500/μL or a percentage count of >7%. Eosinophil levels collected at every visit over one year were categorized as persistently high (PH), persistently low (PL), high-to-low (HL), low-to-high (LH), or variable levels (VL). The study compared variables between PH and non-PH (PL+HL+LH+VL) groups. The patients with baseline eosinophilia were also identified and compared with the non-eosinophilia group. Results: The median disease duration was 3.2 years. Of the patients, 79.4% had diffuse cutaneous SSc and 76.7% had anti-Scl-70 positivity. A total of 11.2%, 66.4%, 1.9%, 8.4%, and 12.1% of the patients were categorized into the PH, PL, HL, LH, and VL groups, respectively. Compared to non-PH groups, the PH group had a higher prevalence of anti-centromere antibody (ACA), higher baseline percent predicted total lung capacity, and lower baseline C-reactive protein and creatine phosphokinase (p<0.05 for all). The ACA positivity (odds ratio [OR]: 18.5; 95% confidence interval [CI]: 1.64-208.46) was associated with PH. The patients with baseline eosinophilia (17.8%) had a higher prevalence of non-specific interstitial pneumonia with periodic eosinophilia at the time of diagnosis (100% vs. 6.5%, p<0.0001; OR: 4.667; 95% CI: 1.712-12.724). Conclusion: The PH was seldom (11%) in patients with SSc compared to periodic eosinophilia, which was more prevalent (18%). It may be related to ACA positivity and better pulmonary outcomes, whereas periodic eosinophilia may involve interstitial lung disease.

scholarly journals Efficacy of Subcutaneous Secukinumab in Patients with Active Psoriatic Arthritis Stratified by Prior Tumor Necrosis Factor Inhibitor Use: Results from the Randomized Placebo-controlled FUTURE 2 Study

2016 ◽  
Vol 43 (9) ◽  
pp. 1713-1717 ◽  
Author(s):  
Arthur Kavanaugh ◽  
Iain B. McInnes ◽  
Philip J. Mease ◽  
Stephen Hall ◽  
Hector Chinoy ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Tumor Necrosis Factor Inhibitor ◽  
American College Of Rheumatology ◽  
Factor Inhibitor ◽  
Future 2 ◽  
Necrosis Factor

Objective.To determine the effect of prior tumor necrosis factor inhibitor (TNFi) therapy on secukinumab efficacy in psoriatic arthritis (PsA).Methods.Patients were randomized to secukinumab 300 mg, 150 mg, 75 mg, or placebo.Results.American College of Rheumatology 20 responses at Week 24 with secukinumab 300 mg, 150 mg, 75 mg, and placebo were 58.2%, 63.5%, 36.9%, and 15.9% in TNFi-naive (n = 258), and 45.5%, 29.7%, 14.7%, and 14.3% in TNFi-exposed patients (n = 139), respectively. Week 52 responses with secukinumab 300 mg, 150 mg, and 75 mg were 68.7%, 79.4%, and 58.5% in TNFi-naive, and 54.5%, 37.8%, and 35.3% in TNFi-exposed patients, respectively.Conclusion.Secukinumab was efficacious in TNFi-naive and TNFi-exposed patients with PsA, with greatest improvements in TNFi-naive patients.

scholarly journals Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study

2021 ◽  
pp. annrheumdis-2020-219014
Author(s):  
Philip J Mease ◽  
Saima Chohan ◽  
Ferran J Garcia Fructuoso ◽  
Michael E Luggen ◽  
Proton Rahman ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
Double Blind Placebo ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Minimal Disease

ObjectivesTo evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).MethodsIn this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs).Results391/500 patients screened were randomised and treated. At W24, 71.4%–79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p<0.01). Patients receiving tildrakizumab versus placebo generally achieved higher rates of ACR50, Disease Activity Score in 28 joints with C reactive protein <3.2, minimal disease activity and 75%/90%/100% improvement from baseline Psoriasis Area and Severity Index responses at W24 and through W52. Improvement in dactylitis and enthesitis was not observed; results were mixed for other outcomes. Responses in patients switched to tildrakizumab 200 mg at W24 were consistent with treatment from baseline. TEAEs and serious TEAEs occurred in 64.5% and 3.3%, respectively, of all patients through W52 and were comparable among treatment arms.ConclusionsTildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52. Clinicaltrials.gov NCT02980692.

scholarly journals Association of C-reactive protein and non-steroidal anti-inflammatory drugs with cardiovascular events in patients with psoriatic arthritis: a time-dependent Cox regression analysis

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110277
Author(s):  
Steven H. Lam ◽  
Ho So ◽  
Isaac T. Cheng ◽  
Edmund K. Li ◽  
Priscilla Wong ◽  
...  
Keyword(s):  
Risk Factors ◽  
Psoriatic Arthritis ◽  
Cox Regression ◽  
Time Varying ◽  
C Reactive Protein ◽  
Cox Regression Analysis ◽  
Reactive Protein ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
Inflammatory Burden

Aims: Psoriatic arthritis (PsA) is associated with accelerated atherosclerosis due to underlying inflammation. Whether inflammatory burden and drugs used to suppress inflammation over time are associated with cardiovascular (CV) events remained unclear. This study aims to examine the time-varying effect of C-reactive protein (CRP) levels and the use of drugs, including non-steroidal anti-inflammatory drugs (NSAIDs) and disease modifying anti-rheumatic drugs, on the risk of CV events independent of traditional CV risk factors in PsA patients. Methods: A retrospective cohort analysis was performed in patients with PsA who were recruited from 2008 to 2015 and followed until the end of 2019. The outcome was occurrence of a first CV event. Framingham risk score (FRS) was used to quantify the traditional CV risk. Cox proportional hazard models with time-varying CRP levels and drugs used were analysed to identify the risk factors for CV events in PsA patients. Results: Two hundred patients with PsA [median age: 47.5 (40.0–56.0); male: 119 (59.5%)] were recruited. After a mean follow-up of 8.8 ± 3.8 years, 30 (15%) patients developed a first CV event. The multivariable Cox regression model showed that time-varying CRP level [hazard ratio (HR) 1.02, 95% confidence interval (CI) 1.00–1.04] and NSAIDs exposure (HR 0.38, 95% CI 0.15–0.96) were significantly associated with CV events after adjusting for baseline FRS (HR 5.06, 95% CI 1.84–13.92). Conclusion: Increased inflammatory burden as reflected by elevated CRP level was associated with increased risk of CV events, while the risk was significantly reduced with NSAIDs use in PsA patients.

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