Psoriatic arthritis (PsA) is a progressive erosive joint disorder that causes functional impairment; therefore, early diagnosis and management are essential. This study evaluated the association ...between clinical specialty and the time to management in patients with PsA in Japan.
This was a subgroup analysis of a cross-sectional, multicenter, observational study that was conducted in 17 countries outside the United States, including 17 sites at 8 institutions in Japan, from June 2016 to October 2017. Data from consecutive patients (age ≥18 years) with a suspected or established diagnosis of PsA on a routine visit to a participating rheumatology/orthopedic or dermatology clinic in Japan were analyzed. The primary endpoints were time from onset of inflammatory musculoskeletal symptoms to PsA diagnosis, PsA diagnosis to first conventional synthetic disease-modifying antirheumatic drug (csDMARD), PsA diagnosis to first biologic DMARD (bDMARD), and first csDMARD to first bDMARD.
Of 109 patients with a confirmed diagnosis of PsA, 39.4% (n = 43) and 60.6% (n = 66) were recruited by rheumatologists/orthopedists and dermatologists, respectively. Most patients were prescribed tumor necrosis factor inhibitors (58.7%) or methotrexate (56.0%). The mean duration from symptom onset to PsA diagnosis was significantly longer (p = 0.044) for patients treated by rheumatologists/orthopedists (70.6 months) than those treated by dermatologists (30.1 months). In the rheumatology/orthopedic and dermatology settings, the mean time from PsA diagnosis to first csDMARD administration was -0.9 and -2.9 months, and from PsA diagnosis to first bDMARD 21.4 and 14.9 months, respectively. The mean duration from administration of first csDMARD to first bDMARD was comparable in the rheumatology/orthopedic (31.8 months) and dermatology (31.5 months) settings.
Treatment approach was slightly different between rheumatology/orthopedic and dermatology setting in clinical practice in Japan, suggesting that an integrated dermo-rheumatologic approach can optimize the management of patients with PsA.
Abstract
Background/Aims
Patients with PsA and axial involvement have higher disease activity and greater reductions in quality of life; however, there are no accepted criteria for identifying axial ...involvement in PsA. The objective of this post-hoc analysis is to assess the efficacy of upadacitinib (UPA), a Janus kinase inhibitor, on axial symptoms in patients with active PsA and axial involvement defined by investigator assessment and PRO-based criteria from two phase 3 SELECT trials.
Methods
Patients with active PsA (≥3 swollen joints and ≥3 tender joints) and prior inadequate response or intolerance to ≥ 1 non-biologic (SELECT-PsA 1) or ≥ 1 biologic (SELECT-PsA 2) DMARD were randomly assigned to once daily oral UPA 15 mg or 30 mg, placebo (PBO), or every other week subcutaneous adalimumab (ADA) 40 mg (SELECT-PsA 1 only). At baseline, axial involvement in PsA was determined by investigator assessment based on the totality of clinical information, such as duration and character of back pain, age of onset, and previous imaging. In addition to investigator assessment, PRO-based criteria for axial involvement (BASDAI ≥4 and BASDAI Question 2 ≥4 at baseline) were applied for this analysis to identify patients with active disease. Efficacy in the sub-group of patients defined using both investigator assessment and PRO-based criteria was evaluated at week 24 for UPA 15 mg vs PBO and ADA (SELECT-PsA 1 only). Data were analyzed using mixed-effect model repeated measures (MMRM) or non-responder imputation (NRI), with nominal P-values shown.
Results
Based on investigator assessment alone, 31.3% (n = 534/1704) of patients in SELECT-PsA 1 and 34.2% (n = 219/641) in SELECT-PsA 2 were defined as having axial involvement. When both investigator assessment and PRO-based criteria were applied, 23.1% (n = 393/1704) of patients in SELECT-PsA 1, or 73.6% (n = 393/534) of those defined using investigator assessment alone, and 27.5% (n = 176/641) in SELECT-PsA 2, or 80.4% (n = 176/219) using investigator assessment alone, met the combined criteria for axial involvement. In both studies, UPA 15 mg showed significantly greater clinical responses vs PBO at week 24 across all endpoints assessed. In SELECT-PsA 1, UPA showed numerically greater responses than ADA at week 24 across all BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints. The proportion of patients achieving ASDAS clinically important improvement (CII) at week 24 was significantly greater with UPA vs ADA based on nominal P-value.
Conclusion
Patients with active PsA and axial involvement defined by both investigator assessment and PRO-based criteria demonstrated statistically greater clinical responses related to their axial involvement with UPA 15 mg compared to PBO, and consistently numerically higher responses compared to ADA, at week 24 in the SELECT-PsA trials. Findings from this post-hoc analysis are consistent with previous data based on investigator assessment alone.
Disclosure
X. Baraliakos: Consultancies; X.B has acted as a consultant for AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB. Member of speakers’ bureau; X.B is a member of speaker bureau for AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB. Grants/research support; X.B has received grant/research AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB. R. Ranza: Consultancies; R.R has Acted as a consultant for AbbVie, Janssen, Novartis, and Pfizer. Member of speakers’ bureau; R.R is a member of speaker bureaus for AbbVie, Janssen, Novartis, and Pfizer. A. Ostor: Consultancies; A.O has acted as a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Gilead, MSD, Novartis, Pfizer, and Roche. Member of speakers’ bureau; A.O is a member of speaker bureaus for AbbVie, Bristol-Myers Squibb, Eli Lilly, Gilead, MSD, Novartis, Pfizer, and Roche. F. Ciccia: Consultancies; F.C. has acted as a consultant for AbbVie, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Janssen, Sanofi, Sandoz, Galapagos, Sobi, and UCB. Member of speakers’ bureau; F.C is a member of speaker bureaus for AbbVie, Bristol-Myers Squibb, Celgene, Novartis, Pfizer, and UCB. Grants/research support; F.C has received grant/research support from AbbVie, Celgene, Pfizer, Roche, and UCB. L.C. Coates: Honoraria; L.C has has received honoraria from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GSK, Janssen, Eli Lilly, Medac, Novartis, Pfizer, and UCB. Grants/research support; L.C has received grant/research support from AbbVie, Amgen, Celgene, Eli Lilly, Novartis and Pfizer. S. Rednic: Consultancies; S.R is a consultant for AbbVie, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, and Pfizer. Grants/research support; S.R has received grant/research support from AbbVie, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Pfizer, and UCB. J. Walsh: Consultancies; J.W has received consultancy fees from AbbVie, Amgen, Eli Lilly, Merck, Novartis, Pfizer, and UCB. Grants/research support; J.W has Grants from AbbVie, Amgen, Eli Lilly, Merck, Novartis, Pfizer, and UCB. T. Gao: Shareholder/stock ownership; T.O is an employee of AbbVie and may hold options and stocks. A. Lertratanakul: Shareholder/stock ownership; A.P is an employee of AbbVie and may hold options and stocks. I. Song: Shareholder/stock ownership; I.S is an employee of AbbVie and may hold options and stocks. F. Fabiana Ganz: Shareholder/stock ownership; F.G is an employee of AbbVie and may hold options and stocks. K. Douglas: Shareholder/stock ownership; K.D is an employee of AbbVie and may hold options and stocks. A. Deodhar: Consultancies; A.D has received consultation fees from AbbVie, Amgen, Aurinia, BMS, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer and UCB. Honoraria; A.D has received honoraria's from AbbVie, Amgen, Aurinia, BMS, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer and UCB. Grants/research support; A.D has received grant/research support from AbbVie, GSK, Lilly, Novartis, Pfizer and UCB.
The objective of this post-hoc analysis was to assess the efficacy and safety of upadacitinib in psoriatic arthritis (PsA) patients with axial involvement.
Post-hoc analysis of SELECT-PsA 1 and ...SELECT-PsA 2 in patients randomized to upadacitinib 15 mg (UPA15), placebo (switched to UPA15 at week 24), or adalimumab 40 mg (ADA; SELECT-PsA 1 only). Axial involvement was determined by investigator judgement (yes or no; based on the totality of available clinical information, such as duration and characteristics of back pain, age of onset, and previous lab investigations and imaging, if available) alone, or investigator judgement and patient-reported outcome (PRO)-based criteria (Bath Ankylosing Spondylitis Disease Activity Index BASDAI ≥ 4 and BASDAI Q2 ≥ 4). Efficacy outcomes that describe axial disease activity, including BASDAI endpoints, such as change from baseline in the overall BASDAI score or proportion of patients achieving BASDAI50 (≥ 50% improvement from baseline), as well as Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints, such as mean change from baseline in overall ASDAS or proportion of patients achieving ASDAS inactive disease or low disease activity, were evaluated at weeks 12, 24, and 56, with nominal P-values shown. Treatment-emergent adverse events (TEAEs) are summarized through week 56.
30.9% of patients in SELECT-PsA 1 and 35.7% in SELECT-PsA 2 had axial involvement by investigator judgement alone; 22.6% (SELECT-PsA 1) and 28.6% (SELECT-PsA 2) had axial involvement by investigator judgement and PRO-based criteria. Greater proportions of patients achieved BASDAI50 with UPA15 versus placebo using either criterion, and versus ADA using investigator judgement alone, at week 24 in SELECT-PsA 1 (investigator alone: UPA15, 59.0%, placebo, 26.9%, P < 0.0001, ADA, 44.1%, P = 0.015; investigator and PRO-based: UPA15, 60.4%, placebo, 29.3%, P < 0.0001, ADA, 47.1%, P = 0.074), with comparable findings in SELECT-PsA 2. Similar results were observed with UPA15 for additional BASDAI and ASDAS endpoints at weeks 12 and 24, with improvements maintained at week 56. Rates of TEAEs were generally similar across sub-groups irrespective of axial involvement status.
PsA patients with axial involvement determined by predefined criteria showed greater BASDAI and ASDAS responses with UPA15 versus placebo, and numerically similar/greater responses versus ADA. Safety results were generally comparable between patients with or without axial involvement.
ClinicalTrials.gov: SELECT-PsA 1, NCT03104400; SELECT-PsA 2, NCT0310437.
Enthesitis is a hallmark of spondyloarthritis (SpA) with a substantial impact on quality of life. Reports of treatment effectiveness across individual enthesitis sites in real-world patients with ...axial SpA (axSpA) are limited. We investigated the evolution of enthesitis following tumor necrosis factor inhibitor (TNFi) initiation in axSpA patients, both cumulatively and at specific axial and peripheral sites.
AxSpA patients in the Swiss Clinical Quality Management Registry were included if they initiated a TNFi, had an available Maastricht Ankylosing Spondylitis Enthesitis Score, modified to include the plantar fascia (mMASES, 0-15), at start of treatment and after 6 and/or 12 months and ≥12 months follow-up. Logistic regression models were utilized to analyze explanatory variables for enthesitis resolution.
Overall, 1668 TNFi treatment courses (TCs) were included, of which 1117 (67%) had active enthesitis at baseline. Reduction in mMASES at the 6- and 12-month timepoints was experienced in 72% and 70% of TCs, respectively. Enthesitis resolution at 6/12 months occurred in 37.9%/43.0% of all TNFi TCs and 40.7%/50.9% of first TNFi TCs. At 6 months, a significant reduction in the frequency of enthesitis was observed at all sites, except for the Achilles tendon and plantar fascia among first TNFi TCs, while at 12 months, reduction was significant at all sites in both TC groups. Enthesitis resolved in 60.3-77% across anatomical sites, while new incident enthesitis occurred in 4.0-13.5% of all TNFi TCs at 12 months. Both baseline and new-incident enthesitis occurred most frequently at the posterior superior iliac spine and the fifth lumbar spinous process. Younger age and lower mMASES at baseline were predictors of complete enthesitis resolution, while female sex and second- or later-line TNFi treatment were associated with persistence of enthesitis at 12 months.
In real-world axSpA patients treated with a TNFi, enthesitis improved in the majority of patients across all anatomical sites. Significant improvement at the Achilles and plantar fascia entheses was observed only at 12 months. Complete and site-specific enthesitis resolution occurred in ≥40% and ≥60% of TCs evaluated at 12 months, with a low incidence of new site-specific enthesitis.
Not applicable.
Introduction
Patients with ankylosing spondylitis (AS) have significant unmet treatment needs, despite advancements in biologic therapies. This study evaluated the impact of upadacitinib on ...clinically meaningful improvement in patient-reported outcomes (PROs) assessing disease activity, pain, fatigue, function, health-related quality of life (HRQoL), and work productivity in patients with AS with inadequate responses or intolerance to biologic disease-modifying antirheumatic drugs (bDMARD-IR).
Methods
Patients enrolled in the phase 3 SELECT-AXIS 2 AS bDMARD-IR study received blinded once-daily oral upadacitinib 15 mg or placebo for 14 weeks. The percentage of patients achieving improvements ≥ minimum clinically important differences (MCID) at week 14 were compared between treatment groups for disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI), patient global assessment of disease activity (PtGA), total and nocturnal back pain, fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F), physical function (Bath Ankylosing Spondylitis Functional Index, BASFI), HRQoL (Assessment of SpondyloArthritis international Society Health Index ASAS HI, Ankylosing Spondylitis Quality of Life ASQoL, Short form-36 SF-36 physical PCS and mental MCS component summary scores), and work productivity (Work Productivity and Activity Impairment WPAI Questionnaire). Mean changes from baseline through week 14 in fatigue and HRQoL were compared between treatment groups.
Results
A total of 420 patients with active AS who were bDMARD-IR were included. A higher proportion of patients reported MCIDs at week 14 across all PROs with upadacitinib compared with placebo (nominal
p
≤ 0.05). Greater improvements in mean change from baseline through week 14 were reported with upadacitinib compared with placebo across FACIT-F, HRQoL, and WPAI, with improvements differentiated as early as week 1 for ASAS HI, ASQoL and SF-36 PCS and week 4 for SF-36 MCS.
Conclusions
Upadacitinib 15 mg demonstrated rapid and clinically meaningful improvements in disease activity, pain, FACIT-F, function, HRQoL, and WPAI among bDMARD-IR patients with active AS.
Trial Registry
Clinical Registration number: NCT04169373, SELECT-AXIS 2.
Objective
To evaluate progression from nonradiographic (nr‐) to radiographic axial spondyloarthritis (r‐axSpA) over 5 years in patients with recently diagnosed (≤1 year) axSpA fulfilling the ...Assessment of SpondyloArthritis international Society (ASAS) classification criteria.
Methods
A prospsective, observational study (Patients with Axial Spondyloarthritis: Multi‐Country Registry of Clinical Characteristics) was conducted in rheumatology practices in 29 countries. Baseline and follow‐up radiographs of sacroiliac joints were centrally evaluated by three readers according to the grading system of the modified New York criteria for patients initially classified as nr‐axSpA. Radiographic progression from nr‐axSpA to r‐axSpA was evaluated by Kaplan‐Meier analysis. Cox proportional regression analyses for progression from nr‐axSpA to r‐axSpA were also conducted.
Results
Among 2,165 patients with axSpA, 1,612 (74%) were classified as having r‐axSpA (1,050 65%) or nr‐axSpA (562 35%) by central reading. Of 246 patients with nr‐axSpA (mean SD symptom duration: 4.4 6.2 years) who had at least one follow‐up sacroiliac joint radiograph, progression from nr‐axSpA to r‐axSpA at any follow‐up visit was observed in 40 patients (16%) over 5 years. Mean time to radiographic progression was 2.4 years (ranging from 0.9 to 5.1 years). Progression to r‐axSpA was associated with male sex (hazard ratio HR 3.16 95% CI 1.22–8.17), fulfillment of the imaging arm of the ASAS classification criteria (HR 6.64 1.37–32.25), and good response to nonsteroidal anti‐inflammatory drugs (HR 4.66 1.23–17.71).
Conclusion
16% of patients with nr‐axSpA progressed to r‐axSpA within 5 years. Male sex, fulfillment of the imaging arm of the ASAS criteria, and good response to nonsteroidal anti‐inflammatory drugs were predictors of radiographic progression in patients with recently diagnosed axSpA.
Introduction
To evaluate the effect of upadacitinib vs. placebo on health-related quality of life (HRQoL) and work productivity in patients with active non-radiographic axial spondyloarthritis ...(nr-axSpA) enrolled in the SELECT-AXIS 2 phase 3 randomized controlled trial.
Methods
Adult patients with active nr-axSpA and an inadequate response to non-steroidal anti-inflammatory drugs were randomized 1:1 to receive upadacitinib 15 mg once daily or placebo. Mean changes from baseline in measures of HRQoL (Ankylosing Spondylitis QoL ASQoL, Assessment of SpondyloArthritis international Society Health Index ASAS HI, Short-Form 36 Physical Component Summary SF-36 PCS score) and Work Productivity and Activity Impairment (WPAI) were assessed through 14 weeks based on mixed-effects repeated measures or analysis of covariance models. The proportions of patients with improvements ≥ minimum clinically important differences (MCID) were assessed in HRQoL measures at week 14 using non-responder imputation with multiple imputation.
Results
At week 14, upadacitinib- vs. placebo-treated patients reported greater improvements from baseline in ASQoL and ASAS HI (ranked,
P
< 0.001) and in SF-36 PCS and WPAI overall work impairment (nominal
P
< 0.05). Improvements were observed as early as week 2 in ASAS HI. Greater proportions of upadacitinib vs. placebo-treated patients reported improvements ≥ MCID in ASQoL (62.6 vs. 40.9%), ASAS HI (44.8 vs. 28.8%), and SF-36 PCS (69.3 vs. 52.0%), with numbers needed to treat < 10 for all (nominal
P
≤ 0.01). Improvements ≥ MCID were consistently observed irrespectively of prior exposure to tumor necrosis factor inhibitors.
Conclusions
Upadacitinib provides clinically meaningful improvements in HRQoL and work productivity in patients with active nr-axSpA.
Clinical Registration Number
NCT04169373, SELECT-AXIS 2.
To compare demographic and clinical characteristics of patients with axial spondyloarthritis (axSpA) across geographic regions.
PROOF is an observational study that enrolled recently diagnosed (≤1 ...year) axSpA patients fulfilling the Assessment of SpondyloArthritis international Society classification criteria from rheumatology clinical practices in 29 countries across 6 geographic regions. Demographics and disease-related parameters were collected. Here we present baseline data for patients who had classification as radiographic (r-)axSpA or non-radiographic (nr-axSpA) confirmed by central reading.
Of the 2170 patients enrolled, 1553 were classified based on central evaluation of sacroiliac radiographs (r-axSpA: 1023 66%; nr-axSpA: 530 34%). Patients with nr-axSpA had significantly higher occurrence of enthesitis (40% vs 33%), psoriasis (10% vs 5%), and inflammatory bowel disease (IBD, 4% vs 2%) vs r-axSpA patients. Significant differences in axSpA characteristics were observed between geographic regions. The highest occurrence of peripheral arthritis (60%), enthesitis (52%), and dactylitis (12%) was in Latin America and the lowest in Canada (9%, 9%, and 2% respectively). Occurrence of uveitis (18%) and psoriasis (14%) was highest in Canada and lowest in China (6% and <1%). IBD was highest in Arabia (21%); no cases were observed in China. In multivariable analysis adjusted for factors potentially affecting peripheral and extra-musculoskeletal manifestations, geographic regions still exhibited significant differences in frequencies of uveitis (p<0.01), psoriasis (p<0.0001) and peripheral arthritis (p<0.0001).
The multinational PROOF study of axSpA patients showed significant regional differences in peripheral and extra-musculoskeletal manifestations of SpA, which could be considered in management guidelines and clinical trials.
Abstract
Background/Aims
Patients (pts) with psoriatic arthritis (PsA) and axial involvement exhibit greater disease activity and quality of life impairments compared with those without axial ...involvement. Here the aim was to characterize PsA pts with and without axial involvement and compare efficacy of UPA vs placebo (PBO) in PsA pts with axial involvement.
Methods
In SELECT-PsA 1 (NCT03104400; N = 1705, non-biologic DMARD IR) and SELECT-PsA 2 (NCT03104374; N = 642, biologic DMARD IR), pts with active PsA (≥3 swollen and ≥3 tender joints), active or historical psoriasis, and on ≤ 2 non-biologic DMARDs were randomized to once daily UPA 15 mg, UPA 30 mg, adalimumab 40 mg every other week (SELECT-PsA 1 only), or PBO. Efficacy was assessed in pts with axial involvement (diagnosed by investigators based on totality of information) pooled from the two studies. Assessments included change from BL in BASDAI, BASDAI Q2 (neck/back/hip pain) and Q3 (joint swelling/pain), and the AS Disease Activity Score (ASDAS-CRP), and percentage with BASDAI 50 response, ASDAS inactive disease (ID), ASDAS low disease activity (LDA), ASDAS major improvement (MI), and ASDAS clinically important improvement (CII). Uveitis and inflammatory bowel disease (IBD) adverse events were reviewed. Data on 24-week PBO-controlled period are presented.
Results
Prevalence of axial involvement was 31.3% in SELECT-PsA 1 and 34.2% in SELECT-PsA 2 (Table). Treatment with UPA 15 mg and 30 mg resulted in significantly greater improvements from BL in the BASDAI, BASDAI Q2 (neck/back/hip pain) and Q3 (joint swelling/pain) and ASDAS-CRP at weeks 12 and 24 vs PBO. Similarly, significantly higher percentages of pts on UPA 15 mg and 30 mg achieved BASDAI 50, ASDAS ID, LDA, MI, and CII at weeks 12 and 24 vs PBO. One pt on UPA 30 mg had incident uveitis, and no IBD was reported on UPA.
Conclusion
PsA pts with axial involvement had higher BL disease burden compared with those without axial involvement. UPA was efficacious in treating axial symptoms in pts with psoriatic spondylitis.
Disclosure
A. Deodhar: Consultancies; A.D. has received consultancy fees from Novartis, Pfizer, AbbVie, Eli-Lilly, UBC Pharma, GlaxoSmithKline, Galapagos, Janssen, Boehringer Ingelheim, Celgene. Member of speakers’ bureau; A.D. is a member of the speakers' bureau of Novartis and Pfizer. Grants/research support; A.D. has received research grants from Novartis, Pfizer, AbbVie, Eli-Lilly, UBC Pharma, GlaxoSmithKline. R. Ranza: Consultancies; R.R. has acted as a consultant to AbbVie, Janssen, Lilly, Novartis, Pfizer. Member of speakers’ bureau; R.R. is a member of the speakers' bureau of AbbVie, Janssen, Lilly, Novartis, Pfizer. Grants/research support; R.R. has received grant/research support from AbbVie, Janssen. F. Ganz: Shareholder/stock ownership; F.G. is an employee of AbbVie and may hold stock or options. T. Gao: Shareholder/stock ownership; T.G. is an employee of AbbVie and may hold stock and options. J. Anderson: Shareholder/stock ownership; J.A. is an employee of AbbVie and may hold stock and options. A. Ostor: Consultancies; A.O. has acted as a consultant for AbbVie, BMS, Roche, Janssen, Lilly, Novartis, UBC, Pfizer, Gilead, Paradigm.
To evaluate the relationship between radiographic progression and disease activity in subjects with PsA treated with adalimumab (ADA) or placebo (PBO) and the impact of concomitant MTX.
This was a ...post hoc analysis of the randomized, double-blind, PBO-controlled ADEPT trial. Subjects were categorized according to time-averaged (TA) disease activity (remission, low, moderate or high) based on Disease Activity Score of 28 joints with CRP DAS28(CRP), Disease Activity Index for Psoriatic Arthritis (DAPSA) or Psoriatic Arthritis Disease Activity Score (PASDAS), and achievement of minimal disease activity (MDA) at week 24. Radiographic progression was assessed as change in modified total Sharp score (ΔmTSS) from baseline to week 24. The analyses included interaction terms between disease activity and treatment on radiographic progression, comparison of radiographic progression in subjects categorized by disease activity and treatment, and correlation between disease activity and radiographic progression by treatment.
The interaction terms for TA disease activity and treatment on ΔmTSS were significant (P = 0.002-0.008). Irrespective of concomitant MTX, ΔmTSS was lower with ADA vs PBO in all disease activity categories. Importantly, even in subjects having moderate or high disease activity or not achieving MDA, ΔmTSS was significantly lower on ADA than PBO (P = 0.05-0.001 for TA-DAPSA, TA-PASDAS and MDA). Correlations between TA disease activity scores and ΔmTSS were moderately positive and significant (P < 0.001) with PBO but non-significant with ADA.
Among subjects with PsA treated with ADA, there was evidence of a 'disconnect' between disease activity and radiographic progression: inhibition of radiographic progression was greater than expected based on control of clinical disease activity alone. MTX had no added effect.
ClinicalTrials.gov, http://clinicaltrials.gov, NCT00646386.
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