Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.

Официальное название

Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. OPTimising IMAging For The Use In The Follow-Up Of Arthritis: The OPTIMA Study

Обзор

The general objective of the OPTIMA study is to assess the time course and interrelationship of imaging (ultrasound and magnetic resonance imaging), clinical, laboratory, and Patient Reported Outcome variables in patients with active Psoriatic Arthritis (any subset) and Rheumatoid Arthritis starting therapy with a Jak-Inhibitor (Upadacitinib), during the first 6 months of follow-up. Participants will be evaluated at the start of therapy with upadacitinib and during the follow-up visits at 2 weeks, 1, 3, and 6 months post-treatment initiation. At each visit (with the exception of the 2-weeks visit), data relating to the clinical evaluation, laboratory tests, and ultrasound of the affected joints will be collected according to standard clinical practice; questionnaires on disease activity will also be completed. In the case of axial involvement, a magnetic resonance imaging will be performed at baseline and after 6 months of therapy, only if required by the standard of care.

Подробное описание

This is a multicentric prospective observational study in which consecutive patients diagnosed with Psoriatic Arthritis (any subset) and Rheumatoid Arthritis, that according to clinicians' evaluation should be treated with Upadacitinib therapy, will be recruited from the outpatient clinic of the Rheumatology Department of the centers included in the study.

The investigators will enroll consecutive patients with Psoriatic Arthritis and Rheumatoid Arthritis with active disease and fulfilling the inclusion and exclusion criteria, from the outpatient clinic of the Rheumatology Units of the participating centers. Written informed consent will be obtained prior to the beginning of the study. All patients, in line with clinical routine practice, will undergo a standard clinical, laboratory, and imaging assessment in order to define the disease activity according to standardized disease activity indexes, at baseline and during the first 3 follow-up visits. For patients starting new treatments for Psoriatic Arthritis and Rheumatoid Arthritis, the follow-up visits are generally scheduled after 1 month (± 1 week), 3 months (± 2 weeks), and 6 months (± 4 weeks) post-treatment initiation, in accordance with international guidelines and local protocols. In case of suspicion of axial involvement, an MRI of the sacroiliac joints will be performed at baseline and, in case of positivity, will be repeated after 6 months (±1 month) in order to assess disease activity at the spine and the treatment efficacy. Regarding the Patient Reported Outcome, the investigators will assess these during the scheduled visits, and two weeks after the initiation of treatment to evaluate earlier pain and functional improvement. The Patient Reported Outcome assessment at two weeks will be administered in a paper form to participants during the baseline visit, and subsequently participants will return these during the first follow-up visit. The data for the study will be retrieved from the medical records of participants and recorded into an appositely created electronic case report form.

Вмешательства

• Препарат Upadacitinib 15 MG [Rinvoq]
  15 mg/ day

Первичные конечные точки

• Difference between US synovitis score [Срок оценки: from baseline to 24 weeks]

Вторичные конечные точки (12)

• Difference between US dactylitis score [Срок оценки: from baseline to 24 weeks]
• Difference between US tenosynovitis score [Срок оценки: from baseline to 24 weeks]
• Difference between US enthesitis score [Срок оценки: from baseline to 24 weeks]
• Difference between US peritendonitis score [Срок оценки: from baseline to 24 weeks]
• Difference between SPARCC MRI index [Срок оценки: from baseline to 24 weeks]
• Difference between T2 mapping scores [Срок оценки: from baseline to 24 weeks]
• Difference between SJC66 [Срок оценки: from baseline to 24 weeks]
• Difference between TJC68 [Срок оценки: from baseline to 24 weeks]
• Difference between the SPARCC score [Срок оценки: from baseline to and 24 weeks]
• Difference between the dactylitis count [Срок оценки: from baseline to 24 weeks]
• Prevalence of BSA = 0 [Срок оценки: after 24 weeks]
• Difference between CRP levels [Срок оценки: from baseline to and 24 weeks]

Критерии участия

The inclusion criteria for Psoriatic Arthritis patients are:

• Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria and with at least one of the following:

• With active peripheral Psoriatic Arthritis regarding ongoing therapy in one of the following sites: MCP joints 1-5, proximal interphalangeal (PIP) joints of hands 1-5, distal interphalangeal (DIP) joints of hands 2-5, wrists, elbows, knees and ankles/heels and feet, according to any of the following criteria:

I) DAPSA ≥ 15 and joint inflammation according to the Global OMERACT-EULAR US scoring for synovitis and power Doppler (GLOESS) with a grade at patient level \>3,2

II) With a clinical enthesitis and an active enthesitis (positive power Doppler of any grade), in the clinical symptomatic site, according to the OMERACT US definitions

III) With active dactylitis (clinical diagnosis made by the physician at the time of baseline visit) and a positive US dactylitis according to the DACTylitis glObal Sonographic (DACTOS) score \>3

IV) DAPSA ≥ 15 and tenosynovitis according to the OMERACT US scoring system for tenosynovitis with a grade \>1

• With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions
• Who are eligible according to the current guidelines/regulations to start treatment with UPA and present a favorable risk/benefit profile according to the clinician's opinion for such treatment.
• Aged older than 18 years.
• Able to provide informed consent, according to requirements of local IRB/ethics committee.

The inclusion criteria for Rheumatoid Arthritis patients are:

• Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria
• With active Rheumatoid Arthritis according to the following criteria: DAS28-PCR \>3.2, and the presence of at least one US finding of the following:

• Joint inflammation at hands and wrists according to the Global OMERACT-EULAR (GLOESS) US scoring for synovitis and power Doppler with a grade at patient level \>2
• One tenosynovitis at hands or wrists, according to the OMERACT US scoring system for tenosynovitis with a grade \>1
• Who are eligible according to the current guidelines/regulations to start treatment with Upadacitinib and present a favourable risk/benefit profile according to the clinician's opinion for such treatment.
• Aged older than 18 years.
• Able to provide informed consent, according to requirements of local IRB/ethics committee.

Критерии исключения

• Patients with any contraindication to Upadacitinib:

• women who are pregnant or breastfeeding
• active infection
• evidence of tuberculosis infection
• known infection with human immunodeficiency virus or hepatitis B or C
• patients who have current malignancy or history of malignancy in the last 5 years
• high cardiovascular risk
• high risk of venous thromboembolism
• patients with severe hepatic impairment
• Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria
• Unable to provide informed consent, according to requirements of local IRB/ethics committee.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 14 центров

• Ospedale Civile di Legnano — Legnano
• IRCCS Ospedale Humanitas — Rozzano
• IRCCS Policlinico San Donato — San Donato
• IRCCS Ospedale Galeazzi-Sant'Ambrogio, — Milan
• IRCCS San Gerardo — Monza
• ASST Papa Giovanni XXIII — Bergamo
• ASST Spedali Civili — Brescia
• ASST Gaetano Pini CTO — Milan
• … и ещё 6 центров

Публикации

• Albano D, Bignone R, Chianca V, Cuocolo R, Messina C, Sconfienza LM, Ciccia F, Brunetti A, Midiri M, Galia M. T2 mapping of the sacroiliac joints in patients with axial spondyloarthritis. Eur J Radiol. 2020 Oct;131:109246. doi: 10.1016/j.ejrad.2020.109246. Epub 2020 Aug 29. PMID 32911127
• Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Williams M, Stone M, Conner-Spady B, Palsat J, Lambert RG. Spondyloarthritis research Consortium of Canada magnetic resonance imaging index for assessment of sacroiliac joint inflammation in ankylosing spondylitis. Arthritis Rheum. 2005 Oct 15;53(5):703-9. doi: 10.1002/art.21445. PMID 16208659
• Lambert RG, Bakker PA, van der Heijde D, Weber U, Rudwaleit M, Hermann KG, Sieper J, Baraliakos X, Bennett A, Braun J, Burgos-Vargas R, Dougados M, Pedersen SJ, Jurik AG, Maksymowych WP, Marzo-Ortega H, Ostergaard M, Poddubnyy D, Reijnierse M, van den Bosch F, van der Horst-Bruinsma I, Landewe R. Defining active sacroiliitis on MRI for classification of axial spondyloarthritis: update by the ASAS PMID 26768408
• Sudol-Szopinska I, Jurik AG, Eshed I, Lennart J, Grainger A, Ostergaard M, Klauser A, Cotten A, Wick MC, Maas M, Miese F, Egund N, Boutry N, Rupreht M, Reijnierse M, Oei EH, Meier R, O'Connor P, Feydy A, Mascarenhas V, Plagou A, Simoni P, Platzgummer H, Rennie WJ, Mester A, Teh J, Robinson P, Guglielmi G, Astrom G, Schueller-Weiderkamm C. Recommendations of the ESSR Arthritis Subcommittee for the PMID 26583367
• Torp-Pedersen S, Christensen R, Szkudlarek M, Ellegaard K, D'Agostino MA, Iagnocco A, Naredo E, Balint P, Wakefield RJ, Torp-Pedersen A, Terslev L. Power and color Doppler ultrasound settings for inflammatory flow: impact on scoring of disease activity in patients with rheumatoid arthritis. Arthritis Rheumatol. 2015 Feb;67(2):386-95. doi: 10.1002/art.38940. PMID 25370843
• Moller I, Janta I, Backhaus M, Ohrndorf S, Bong DA, Martinoli C, Filippucci E, Sconfienza LM, Terslev L, Damjanov N, Hammer HB, Sudol-Szopinska I, Grassi W, Balint P, Bruyn GAW, D'Agostino MA, Hollander D, Siddle HJ, Supp G, Schmidt WA, Iagnocco A, Koski J, Kane D, Fodor D, Bruns A, Mandl P, Kaeley GS, Micu M, Ho C, Vlad V, Chavez-Lopez M, Filippou G, Ceron CE, Nestorova R, Quintero M, Wakefield R PMID 28814430
• Gutierrez M, Filippucci E, Salaffi F, Di Geso L, Grassi W. Differential diagnosis between rheumatoid arthritis and psoriatic arthritis: the value of ultrasound findings at metacarpophalangeal joints level. Ann Rheum Dis. 2011 Jun;70(6):1111-4. doi: 10.1136/ard.2010.147272. Epub 2011 Mar 15. PMID 21406459
• Moon SJ, Lee WY, Hwang JS, Hong YP, Morisky DE. Accuracy of a screening tool for medication adherence: A systematic review and meta-analysis of the Morisky Medication Adherence Scale-8. PLoS One. 2017 Nov 2;12(11):e0187139. doi: 10.1371/journal.pone.0187139. eCollection 2017. PMID 29095870

Идентификаторы

NCT: NCT06630715 · OPTIMA (L4182)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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