scholarly journals Effect of tofacitinib treatment on active MRI sacroiliitis in psoriatic arthritis patients

2021 ◽  
Vol 59 (2) ◽  
pp. 134-140
Author(s):  
E. E. Gubar ◽  
Yu. L. Korsakova ◽  
E. Yu. Loginova ◽  
A. V. Smirnov ◽  
S. I. Glukhova ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
High Activity ◽  
Sacroiliac Joint ◽  
Kinase Inhibitor ◽  
Janus Kinase ◽  
High Efficacy ◽  
Sacroiliac Joints ◽  
Low Activity ◽  
Very High ◽  
Axial Involvement

Axial involvement in psoriatic arthritis is quite common. There is no data on the use of tofacitinib, an oral Janus kinase inhibitor, in psoriatic arthritis patients with axial involvement, nor is there any data on its effect on active MRI sacroiliitis.The aim of the study was to assess the effect of tofacitinib therapy on the dynamics of active MRI sacroiliitis in psoriatic arthritis patients.Materials and methods. 41 patients with active psoriatic arthritis fulfilling the CASPAR criteria were included. Median age was 41.0 [34; 50] years old, median disease duration was 6.0 [3; 10] years. Apart from a standard clinical examination, 40 patients underwent sacroiliac joint MRI on scanner Siemens General Electric 1.5 TESLA. Bone marrow edema on MRI (STIR) with one lesion on two consecutive slices or at least two lesions on a single slice, was considered active MRI sacroiliitis. Tofacitinib was given in 5 mg tablets twice a day with a possible dose increase up to 10 mg twice a day after 12 weeks of therapy. At the end of study, over a period of 24 weeks, sacroiliac joint MRI examination was repeated in 35 patients.Results. Prior to tofacitinib therapy, active MRI sacroiliitis was detected in 14 of 40 (35%) patients: bilateral – in 9 patients, unilateral – in 5 patients. At the end of 24 weeks therapy, active MRI sacroiliitis was detected in 4 of 35 (11.4%) patients observed: in 1 patient with baseline bilateral MRI sacroiliitis and in 2 patients with unilateral MRI sacroiliitis. 1 patient showed negative dynamics, that is, development of active MRI sacroiliitis (absent at baseline). The decrease in number of active MRI sacroiliitis patients is statistically significant (p=0.017). At baseline, inflammatory changes were detected in 23 of 80 (28.8%) sacroiliac joints, after 24 weeks of therapy they were found in 5 of 70 (7.1%; p=0.001) sacroiliac joints observed. During the treatment period, there was a significant decrease in the initially high activity of spondylitis. After 24 weeks of treatment, median BASDAI decreased from 6.0 [4.2; 7.0] to 1.4 [0.6; 3.2], median ASDAS-CRP from 3.8 [2.8; 4.4] to 1.5 [1.0; 2.1] (p=0.001 for both comparisons). Prior to tofacitinib therapy, high activity according to BASDAI was observed in 90.2% of patients, low activity – in 9.8%; at the end of study – in 13.5% and 86.5% of patients, respectively (p=0.001). At baseline, very high activity by ASDAS-CRP was detected in 61% of patients, high activity – in 29.2%, low activity – in 9.8% of patients. At the end of study there weren’t any patients with very high activity by ASDAS-CRP (p=0.001), high activity remained in 23.1%, moderate and low activity – in 30.7% and 46.2% of patients, respectively (p=0.001 for both comparisons). Significant differences between baseline symptoms in patients with MRI sacroiliitis and without it were defined by number of digits with dactylitis – 2 [0; 4] and 0 [0; 2] (p=0.04) and by ESR values – 47 [26; 76] and 20 [6; 37] mm/h (p=0.02). These parameters were higher in MRI sacroiliitis subgroup. By the end of study, these differences leveled out: the number of digits with dactylitis decreased to 0 [0; 0] and 0 [0; 0] (р=0.48), ESR – to 12 [6; 16] and 8 [6; 16] mm/h, respectively (p=0.78).Conclusion. Tofacitinib therapy shows high efficacy in reducing active MRI sacroiliitis and decreasing activity of axial involvement in psoriatic arthritis patients. The use of tofacitinib in patients with active MRI sacroiliitis as well as dactylitis and increased ESR levels demonstrated its high efficacy.

scholarly journals SAT0418 EFFECT OF TOFACITINIB TREATMENT ON ACTIVE MRI SACROILIITIS AND DISEASE ACTIVITY REDUCTION IN PSORIATIC ARTHRITIS PATIENTS. DATA FROM CLINICAL PRACTICE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1162.1-1162
Author(s):  
E. Gubar ◽  
T. Korotaeva ◽  
Y. Korsakova ◽  
E. Loginova ◽  
P. Karpova
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Clinical Examination ◽  
Kinase Inhibitor ◽  
Statistical Significance ◽  
Janus Kinase ◽  
Inflammatory Back Pain ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Axial Involvement

Background:Axial involvement in psoriatic arthritis (PsA) is quite common. Tofacitinib (TOFA) is an oral Janus kinase inhibitor. There is no data on the use of TOFA in PsA patients (pts) with axial involvement, nor is there any data on its effect on active MRI sacroiliitis (MRI-SI). There are only preliminary results of a randomized clinical trial on TOFA efficacy on active SI in AS (1).Objectives:To study the effect of TOFA therapy on active MRI-SI in PsA pts.Methods:40 pts (F/M – 23/17) with active PsA fulfilling the CASPAR criteria were examined. No patients with inflammatory back pain (IBP) were specifically selected. Median (Me) age 41.0 [35.0; 50.0] yrs, Me PsA duration 6.0 [3.0; 10.0] yrs. Pts underwent a standard clinical examination of PsA activity: Me tender joint count 19 [12; 24], swollen joint count 11 [8; 16], patient’s global disease activity measured by Visual Analogue Scale (VAS) 70 [50; 80], patient’s pain VAS 65 [50; 75], Me activity indixes: DAPSA 44.2 [37.8; 55.3], BASDAI 6.0 [4.2; 7.0], ASDAS 3.8 [2.8; 4.4]. Me CRP 21.3 [3.2; 72.3] mg/L, ESR 28 [12; 52] mm/h. Enthesitis was observed in 65.9% of pts, dactylitis in 53.7% of pts. Apart from a standard clinical examination, all 40 pts underwent sacroiliac joint (SIJ) MRI on scanner Siemens General Electric 1.5 TESLA. Bone marrow edema/osteitis on MRI (STIR) with one lesion on two consecutive slices or at least two lesions on a single slice, was considered active MRI-SI. MRI results were evaluated by 2 independent readers (radiologist and rheumatologist). TOFA was given in 5 mg tablets bds over a period of 6 months, after which 35 patients underwent SIJ MRI. Me [Q25; Q75], Pierson-χ2tests were performed. All p<0.05 were considered to indicate statistical significance.Results:Prior to TOFA therapy, active MRI-SI was detected in 14 of 40 (35%) pts: bilateral in 9 pts, unilateral in 5 pts. At the end of 6 months therapy, active MRI-SI was detected in 4 of 35 (11.4%) pts observed: in 1 pt with baseline bilateral MRI-SI and in 2 pts with unilateral MRI-SI. 1 pt showed negative dynamics, that is, development of active MRI-SI (absent at baseline). The decrease in number of active MRI-SI patients is statistically significant (p = 0.017; Pearson-χ2). At baseline, inflammatory changes were detected in 23 of 80 (28.8%) SIJs, after 6 months of therapy they were found in 5 of 70 (7.1%) SIJs observed. Decrease in number of SIJs with active inflammation is statistically significant (p = 0.001; Pearson-χ2). At baseline, Me BASDAI 6.0 [4.2; 7.0], Me ASDAS 3.8 [2.8; 4.4]. After 6 months of treatment, Me BASDAI 1.4 [0.6; 3.2], Me ASDAS1.5 [1.0; 2.1] (p = 0.001 for both comparisons).Conclusion:JAK inhibition using TOFA therapy shows high efficacy in reducing active MRI-SI and decreasing activity of axial involvement in PsA. More extensive studies are needed.References:[1]van der Heijde D. et al. Ann. Rheum. Dis. 2017;76:1340–47Disclosure of Interests:ELENA GUBAR: None declared, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Yulia Korsakova: None declared, Elena Loginova Speakers bureau: Janssen, Polina Karpova: None declared

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 Occult axial involvement in patients with psoriatic arthritis mutilans: a case report

Reumatismo ◽  
2019 ◽  
Vol 71 (2) ◽  
pp. 88-91
Author(s):  
F.M. Perrotta ◽  
S. Scriffignano ◽  
A. De Socio ◽  
E. Lubrano
Keyword(s):  
Magnetic Resonance Imaging ◽  
Case Report ◽  
Psoriatic Arthritis ◽  
Clinical Symptoms ◽  
Resonance Imaging ◽  
Sacroiliac Joints ◽  
Articular Damage ◽  
Active Inflammation ◽  
Axial Involvement ◽  
Arthritis Mutilans

We present the case of a patient with psoriatic arthritis (PsA) mutilans and occult axial involvement. The patient had suffered from PsA mutilans for more than a decade, with severe residual articular damage, but had been in clinical remission for years. Clinical axial involvement was never reported; however, magnetic resonance imaging of the sacroiliac joints, performed for other reasons, documented active inflammation and damage even without clinical symptoms. These findings corroborated the hypothesis that axial involvement could be asymptomatic, subclinical and, furthermore, underdiagnosed or even occult in patients with PsA mutilans, in which cases it should be carefully evaluated.

scholarly journals Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2

2020 ◽  
pp. annrheumdis-2020-218870
Author(s):  
Philip J Mease ◽  
Apinya Lertratanakul ◽  
Jaclyn K Anderson ◽  
Kim Papp ◽  
Filip Van den Bosch ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Kinase Inhibitor ◽  
Signs And Symptoms ◽  
Janus Kinase ◽  
Inadequate Response ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
American College Of Rheumatology ◽  
Trial Drug

BackgroundUpadacitinib is a Janus kinase inhibitor under evaluation for the treatment of psoriatic arthritis (PsA). We evaluated upadacitinib in patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD).MethodsIn this 24-week randomised, placebo-controlled, double-blind, phase 3 trial, 642 patients were randomised (2:2:1:1) to once per day upadacitinib 15 mg or 30 mg, placebo followed by upadacitinib 15 mg or placebo followed by upadacitinib 30 mg at week 24. The primary endpoint was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 12. Achievement of minimal disease activity (MDA) was assessed at week 24. Treatment-emergent adverse events are reported for all patients who received at least one dose of trial drug.ResultsAt week 12, significantly more patients receiving upadacitinib 15 mg and 30 mg versus placebo achieved ACR20 (56.9% and 63.8% vs 24.1%; p<0.001 for both comparisons). At week 24, MDA was achieved by more upadacitinib 15 mg-treated (25.1%) and 30 mg-treated patients (28.9%) versus placebo (2.8%; p<0.001 for both comparisons). Generally, the rates of treatment-emergent adverse events were similar with placebo and upadacitinib 15 mg and higher with upadacitinib 30 mg at week 24. Rates of serious infections were 0.5%, 0.5% and 2.8% with placebo, upadacitinib 15 mg and upadacitinib 30 mg, respectively.ConclusionIn this trial of patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD, upadacitinib 15 mg and 30 mg was more effective than placebo over 24 weeks in improving signs and symptoms of PsA.Clinical trial registration numberNCT03104374

scholarly journals Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110579
Author(s):  
Denis Poddubnyy ◽  
Xenofon Baraliakos ◽  
Filip Van den Bosch ◽  
Jürgen Braun ◽  
Laura C. Coates ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Cross Sectional Study ◽  
Classification Criteria ◽  
Musculoskeletal Symptom ◽  
Psoriatic Skin ◽  
Symptom Duration ◽  
Sectional Study ◽  
Sacroiliac Joints ◽  
Cross Sectional ◽  
Axial Involvement

Background: Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are referred to as psoriatic arthritis (PsA). Data suggest that up to 30% of patients with psoriasis have PsA. Depending on the definition used, the prevalence of axial involvement varies from 25% to 70% of patients with PsA. However, there are currently no widely accepted criteria for axial involvement in PsA.Objective: The overarching aim of the Axial Involvement in Psoriatic Arthritis (AXIS) study is to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research. Design: Prospective, multicenter, multinational, cross-sectional study. Methods and analyses: In this multicenter, multinational, cross-sectional study, eligible patients [adult patients diagnosed with PsA and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) with musculoskeletal symptom duration of ⩽10 years not treated with biological or targeted synthetic disease-modifying anti-rheumatic drugs] will be recruited prospectively. They will undergo study-related clinical and imaging examinations. Imaging will include radiography and magnetic resonance imaging examinations of sacroiliac joints and spine. Local investigators will evaluate for the presence of axial involvement based on clinical and imaging information which will represent the primary outcome of the study. In addition, imaging will undergo evaluation by central review. Finally, the central clinical committee will determine the presence of axial involvement based on all available information. Ethics: The study will be performed according to the ethical principles of the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice guidelines. The study protocol will be approved by the individual Independent Ethics Committee / Institutional Review Board of participating centers. Written informed consent will be obtained from all included patients.Registration: ClinicalTrials.gov ID: NCT04434885.

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