2018 APLAR axial spondyloarthritis treatment recommendations

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Abstract

Despite the availability of axial spondyloarthritis (SpA) recommendations proposed by various rheumatology societies, we considered that a region-specific guideline was of substantial added value to clinicians of the Asia-Pacific region, given the wide variations in predisposition to infections and other patient factors, local practice patterns, and access to treatment across countries.

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Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial.

C Antoni, G Krueger, K De Vlam … (2005)

To evaluate further in a phase III, double blind trial the efficacy of infliximab in patients with active psoriatic arthritis (PsA), as observed in the smaller IMPACT trial. 200 patients with active PsA unresponsive to previous treatment were randomised to infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, 14, and 22. Patients with inadequate response entered early escape at week 16. The primary measure of clinical response was ACR20. Other measures included Psoriatic Arthritis Response Criteria (PsARC), Psoriasis Area and Severity Index (PASI), and dactylitis and enthesopathy assessments. At week 14, 58% of patients receiving infliximab and 11% of those receiving placebo achieved an ACR20 response and 77% of infliximab patients and 27% of placebo patients achieved PsARC (both p<0.001). Among the 85% of patients with at least 3% body surface area psoriasis involvement at baseline, 53/83 (64%) patients receiving infliximab had at least 75% improvement in PASI compared with 2/87 (2%) patients receiving placebo at week 14 (p<0.001). These therapeutic effects were maintained through the last evaluation (week 24). Fewer infliximab patients than placebo patients had dactylitis at week 14 (18% v 30%; p = 0.025) and week 24 (12% v 34%; p<0.001). Fewer infliximab patients (22%) than placebo patients (34%) had active enthesopathy at week 14 (p = 0.016); corresponding figures at week 24 were 20% and 37% (p = 0.002). Infliximab was generally well tolerated, with a similar incidence of adverse events in each group. Infliximab 5 mg/kg through 24 weeks significantly improved active PsA, including dactylitis and enthesopathy, and associated psoriasis.

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

Dominique LP Baeten, Mikkel Østergaard, James Cheng-Chung Wei … (2018)

Objectives To 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). Methods A 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. Results At 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. Conclusions Treatment 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 number NCT02047110; Pre-results.

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The global burden of tuberculosis: results from the Global Burden of Disease Study 2015

Shafiu Mohammed (2017)

Summary Background An understanding of the trends in tuberculosis incidence, prevalence, and mortality is crucial to tracking of the success of tuberculosis control programmes and identification of remaining challenges. We assessed trends in the fatal and non-fatal burden of tuberculosis over the past 25 years for 195 countries and territories. Methods We analysed 10 691 site-years of vital registration data, 768 site-years of verbal autopsy data, and 361 site-years of mortality surveillance data using the Cause of Death Ensemble model to estimate tuberculosis mortality rates. We analysed all available age-specific and sex-specific data sources, including annual case notifications, prevalence surveys, and estimated cause-specific mortality, to generate internally consistent estimates of incidence, prevalence, and mortality using DisMod-MR 2.1, a Bayesian meta-regression tool. We assessed how observed tuberculosis incidence, prevalence, and mortality differed from expected trends as predicted by the Socio-demographic Index (SDI), a composite indicator based on income per capita, average years of schooling, and total fertility rate. We also estimated tuberculosis mortality and disability-adjusted life-years attributable to the independent effects of risk factors including smoking, alcohol use, and diabetes. Findings Globally, in 2015, the number of tuberculosis incident cases (including new and relapse cases) was 10·2 million (95% uncertainty interval 9·2 million to 11·5 million), the number of prevalent cases was 10·1 million (9·2 million to 11·1 million), and the number of deaths was 1·3 million (1·1 million to 1·6 million). Among individuals who were HIV negative, the number of incident cases was 8·8 million (8·0 million to 9·9 million), the number of prevalent cases was 8·9 million (8·1 million to 9·7 million), and the number of deaths was 1·1 million (0·9 million to 1·4 million). Annualised rates of change from 2005 to 2015 showed a faster decline in mortality (–4·1% [–5·0 to –3·4]) than in incidence (–1·6% [–1·9 to –1·2]) and prevalence (–0·7% [–1·0 to –0·5]) among HIV-negative individuals. The SDI was inversely associated with HIV-negative mortality rates but did not show a clear gradient for incidence and prevalence. Most of Asia, eastern Europe, and sub-Saharan Africa had higher rates of HIV-negative tuberculosis burden than expected given their SDI. Alcohol use accounted for 11·4% (9·3–13·0) of global tuberculosis deaths among HIV-negative individuals in 2015, diabetes accounted for 10·6% (6·8–14·8), and smoking accounted for 7·8% (3·8–12·0). Interpretation Despite a concerted global effort to reduce the burden of tuberculosis, it still causes a large disease burden globally. Strengthening of health systems for early detection of tuberculosis and improvement of the quality of tuberculosis care, including prompt and accurate diagnosis, early initiation of treatment, and regular follow-up, are priorities. Countries with higher than expected tuberculosis rates for their level of sociodemographic development should investigate the reasons for lagging behind and take remedial action. Efforts to prevent smoking, alcohol use, and diabetes could also substantially reduce the burden of tuberculosis. Funding Bill & Melinda Gates Foundation.

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Author and article information

Journal

Title: International Journal of Rheumatic Diseases

Abbreviated Title: Int J Rheum Dis

Publisher: Wiley

ISSN (Print): 1756-1841

ISSN (Electronic): 1756-185X

Publication date Created: December 17 2018

Publication date Created: March 2019

Publication date (Electronic): February 28 2019

Publication date (Print): March 2019

Volume: 22

Issue: 3

Pages: 340-356

Affiliations

[1 ]Department of Medicine and Therapeutics The Chinese University of Hong Kong Shatin Hong Kong

[2 ]Institute of Medicine Chung Shan Medical University Taichung Taiwan

[3 ]Department of Medicine Chung Shan Medical University Hospital Taichung Taiwan

[4 ]Graduate Institute of Integrated Medicine China Medical University Taichung Taiwan

[5 ]Department of Clinical Immunology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India

[6 ]Division of Rheumatology, Department of Internal Medicine, Gil Medical Center Gachon University College of Medicine Incheon Korea

[7 ]Division of Rheumatology National University Hospital and Yong Loo Lin School of Medicine, National University of Singapore Singapore City Singapore

[8 ]Department of Medicine, Faculty of Medicine Siriraj Hospital Mahidol University Bangkok Thailand

[9 ]Department of Pediatrics and Clinical Epidemiology Philippine General Hospital, University of the Philippines Manila Philippines

[10 ]Department of Rheumatology Third Affiliated Hospital of Sun Yat‐sen University Guangzhou China

[11 ]Division of Hematology and Rheumatology Teikyo University Chiba Medical Center Chiba Japan

[12 ]Immuno‐Rheumatology Center St Luke`s International Hospital, St Luke`s International University Tokyo Japan

[13 ]Division of Rheumatology, Department of Medicine Philippine General Hospital, University of the Philippines Manila Philippines

[14 ]AJA University of Medical Sciences, Rheumatology Research Center Tehran Iran

[15 ]Department of Medicine Dunedin School of Medicine University of Otago Dunedin New Zealand

[16 ]The Queen Elizabeth Hospital, University of Adelaide Adelaide South Australia Australia

[17 ]Department of Medicine Subang Jaya Medical Centre Subang Jaya Malaysia

[18 ]Division of Rheumatology and Clinical Immunology, Department of Medicine The University of Hong Kong Pokfulam Hong Kong

Article

DOI: 10.1111/1756-185X.13510

PubMed ID: 30816645

SO-VID: dd3b4b04-1c9c-4d6c-8c3f-dc32887624e3

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2018 APLAR axial spondyloarthritis treatment recommendations

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MoRePaS 2018 - Model Reduction of Parametrized Systems IV

Most cited references 126

Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial.

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

The global burden of tuberculosis: results from the Global Burden of Disease Study 2015

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