THU0077 RHEUMATOID ARTHRITIS AND ANKYLOSING SPONDYLITIS CLINICAL TRIALS: HOW TO ENCOURAGE PATIENTPARTICIPATION? RESULTS FROM A REAL-WORLD STUDY CONDUCTED VIA CARENITY, A WORLDWIDE ONLINE PATIENT COMMUNITY

Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour necrosis factor inhibition (TNFi) who would have been eligible for relevant clinical trials, and whether treatment response differs between these groups and the trials themselves. The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) recruited a real-world cohort of TNFi-naïve spondyloarthritis patients with data collection from clinical records and patient questionnaires. Participant characteristics were extracted from trials identified from a recent Health Technology Assessment of TNFi for ankylosing spondylitis/non-radiographic axial spondyloarthritis. Descriptive statistics were used to determine the differences, including treatment response, between BSRBR-AS participants who would/would not have been eligible for the clinical trials and with trial participants. Among 2420 BSRBR-AS participants, those commencing TNFi (34%) had shorter symptom duration (15 vs 22 years) but more active disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 6.4 vs 4.0; Bath Ankylosing Spondylitis Disease Functional Index (BASFI) 6.2 vs 3.8). Of those commencing TNFi, 41% met eligibility criteria for ≥1 of fourteen relevant trials; they reported higher disease activity (BASDAI 6.9 vs 6.1) and poorer function (BASFI 6.6 vs 6.0). 61.7% of trial participants reported a positive treatment response, vs 51.3% of BSRBR-AS patients (difference: 10.4%; 95% CI 4.4% to 16.5%). Potential eligibility for trials did not influence treatment response (difference 2.0%; -9.4% to 13.4%). Fewer patients in the real world respond to TNFi than is reported in the trial literature. This has important implications for the generalisability of trial results, and the cost-effectiveness of TNFi agents.

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Real-world evidence of the impact of adalimumab on work productivity and sleep measures in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x20949088 ◽

2020 ◽

Vol 12 ◽

pp. 1759720X2094908

Author(s):

Maria G. Tektonidou ◽

Gkikas Katsifis ◽

Athanasios Georgountzos ◽

Athina Theodoridou ◽

Eftychia-Maria Koukli ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Real World ◽

Sleep Problems ◽

Work Productivity ◽

Routine Care ◽

Activity Impairment ◽

Work Impairment

Objective: Our aim was to evaluate the effect of adalimumab on work productivity measures, overall activity impairment, and sleep quality in patients with active moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) treated in routine care settings in Greece and determine factors associated with work impairment and sleep disturbance. Methods: Patients with active moderate to severe RA ( n = 184), PsA ( n = 166), and AS ( n = 150) were enrolled in this 24-month, prospective, observational study at 80 hospital outpatient clinics and private practices throughout Greece. Patients received adalimumab alone or in combination with standard antirheumatic therapies according to routine care. Work productivity and sleep were assessed through two patient-reported outcome measures: the Work Productivity and Activity Impairment–General Health questionnaire and the Medical Outcomes Study Sleep Scale (MOS-SS). Pearson correlation coefficients were estimated to assess the association of work impairment and sleep disturbances with disease activity scores. Results: In the overall population, adalimumab significantly lowered absenteeism [mean (95% confidence interval) reduction, 18.9% (13.3–24.5%); n = 100]; presenteeism [40.0% (33.8–46.3%); n = 98], overall work productivity impairment [46.8% (40.4–53.2%); n = 94], activity impairment [47.0% (44.3–49.6); n = 421], and the MOS-SS sleep problems index [31.6 (29.5–34.1); n = 421] after 24-month treatment ( p < 0.001). Significant improvements were also noted across the RA, PsA, and AS subpopulations ( p < 0.05). Improvements in overall work impairment and sleep disturbance positively correlated with improvements in disease activity measures. Conclusion: Adalimumab improves work productivity and sleep problems while lowering disease activity in patients with moderate to severe RA, PsA, and AS managed in real-world settings.

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PMS20 Patients Reported Outcomes in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis Treated With Golimumab: Sub-Analysis of Asia Population Enrolled in Multicentre Phase Iii Clinical Trials

Value in Health ◽

10.1016/j.jval.2012.08.421 ◽

2012 ◽

Vol 15 (7) ◽

pp. A674

Author(s):

M. Genovese ◽

A. Deodhar ◽

E. Hsia ◽

B. Hsu ◽

Y.J. Lin ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trials ◽

Ankylosing Spondylitis ◽

Phase Iii ◽

Multicentre Phase ◽

Phase Iii Clinical Trials ◽

Patients Reported Outcomes

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Rheumatology

10.1093/med/9780198729426.003.0018 ◽

2016 ◽

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trials ◽

Ankylosing Spondylitis ◽

Rheumatic Diseases ◽

Clinical Manifestations ◽

Special Focus ◽

Clear Understanding

This chapter focuses on some of the most influential clinical trials in rheumatology, with special focus on rheumatoid arthritis, ankylosing spondylitis, and gout. Today, there are clear criteria established for the clinical manifestations of rheumatic diseases, but there is still a long way to go in terms of establishing a clear understanding of their pathogenesis.

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CT-P13 subcutaneous infliximab in gastroenterology and rheumatology

Immunotherapy ◽

10.2217/imt-2020-0339 ◽

2021 ◽

Author(s):

Mai Ahmed ◽

Giulia Bankov ◽

Dan Casey ◽

Martin Edward Perry

Keyword(s):

Rheumatoid Arthritis ◽

Ulcerative Colitis ◽

Clinical Trials ◽

Real World ◽

Intravenous Therapy ◽

Self Administration ◽

Efficacy Data ◽

Inflammatory Conditions ◽

Therapy Choice ◽

Cost Implications

The drug infliximab has been a key milestone in the treatment of inflammatory conditions such as Crohn's disease, ulcerative colitis, rheumatoid arthritis and the seronegative spondyloarthritides. Biosimilar drugs followed the originator, further improving access and diversity of therapy choice. Subcutaneous infliximab (CT-P13) holds potential for greater patient flexibility by self administration, reducing travel and hospital attendance for infusion, particularly relevant at a time of pandemic. We highlight the pharmacodynamic and pharmacokinetic basis of the subcutaneous device, clinical trials in rheumatology and gastroenterology and consider the safety and cost implications. Real-world switching data is required to confirm the efficacy data from clinical trials given the reduction in dosing flexibility compared with intravenous therapy.

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P198 Efficacy and safety of secukinumab in ankylosing spondylitis: real-world data from Midlands Ankylosing Spondylitis Collaboration (MASC)

Rheumatology ◽

10.1093/rheumatology/keab247.193 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Nibha Jain ◽

Ramasharan Laxminarayan ◽

Arumugam Moorthy ◽

Roshan Amarasena ◽

Natasha Cleaton ◽

...

Keyword(s):

Clinical Trials ◽

Ankylosing Spondylitis ◽

Clinical Improvement ◽

Real World ◽

Patient Choice ◽

Efficacy And Safety ◽

Real World Data ◽

Data Set ◽

World Data ◽

Leicester Royal Infirmary

Abstract Background/Aims Secukinumab is an interleukin-17 inhibitor has been found to be effective in the treatment of ankylosing spondylitis (AS) in studies, including phase 3 clinical trials, however these are conducted in highly selected patients and it is important to confirm the efficacy and safety in a real world data. Response to secukinumab should be assessed after 16-weeks and continued if there has been sufficient response to treatment according to the BASDAI and spinal VAS scores. Methods This was a multicentre cross-sectional observational study in collaboration with Midland Ankylosing Spondylitis Collaboration. Consecutive baseline and 16th week data of all AS patients on Secukinumab from 2017 to 2019 were collected and analysed to assess treatment response. All data were compiled in excel sheets and analysed using Medcalc calculator. Data were collected from collaborative efforts of the Royal Wolverhampton NHS trust, Queen’s Hospital (Burton on Trent), Leicester Royal Infirmary and Robert Jones and Agnes Hunt hospital. Results Total 92 patients with radiographic AS on standard dose of secukinumab were included at baseline and 88 were followed up till week 16. Mean age was 45.9(SD ± 15) (Median=44years) and 67% were male. Baseline Mean BASDAI was 7 (SD ± 1.7); Mean CRP was 16.6 (SD ± 11.2), Mean VAS was 7.6(SD ± 1.6). There was statistical significant change in BASDAI, VAS and CRP levels at week 16th. ΔBASDAI=2.2 (SD ± 2) (p = 0.002), ΔVAS=3.2 (SD ± 2.1) (p = 0.001), ΔCRP=6.9 (SD ± 17) (p = 0.03). At 16th week, 68% had clinical improvement while 4 patients discontinued therapy (2-colitis, 1-uveitis and 1-patient choice). 10% overall had some adverse effects with most common being upper respiratory tract infection. We also compared patients with previous anti-TNF exposure (TE) to Anti-TNF naïve (TN). 63% were in TE group vs 37% in TN. 69% of TE and 76% of TN showed clinical improvement at week 16.Mean ΔBASDAI was more in TN group vs TE (p = 0.01), however there was no difference in ΔVAS and ΔCRP levels. (p = 0.0 & p = 0.2 respectively). Conclusion This multi-centre retrospective analysis found secukinumab to be clinically effective in 68% of patients with AS. There was significant improvement in BASDAI, VAS and CRP levels at week16. Compared to anti-TNF resistant patients, TNF-Naïve responded better to secukinumab, although both showed good clinical improvement. These findings support the use of secukinumab in the treatment of AS, as a first line therapy or for those who have failed anti-TNF therapy. Safety signals observed in the real-word data set were consistent with those seen in the clinical trials and the Summary of Product Characteristics. Disclosure N. Jain: None. R. Laxminarayan: Honoraria; Honorarium from Novartis, Lilly, Pfizer and Abvie. A. Moorthy: Honoraria; Speaker and conference fee MSD, Novartis, Abbvie. R. Amarasena: None. N. Cleaton: None. G. Kakade: None. A. Gunawardane: None. T. Khan: None. H. Sapkota: None. N. Barkham: Grants/research support; research funding from Novartis, Eli Lilly, UCB.

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