Pain Global Assessment Research Articles

Unacceptable Work State in Rheumatoid Arthritis: Establishment of Thresholds for Presenteeism and Clinical Measurement Instruments.

We aimed to identify threshold values of presenteeism measurement instruments that reflect unacceptable work state in employed patients with rheumatoid arthritis (RA) and whether those thresholds can predict future adverse work outcomes (AWOs). Additionally, we assessed the performance of presenteeism thresholds previously established in axial spondyloarthritis (axSpA) among patients with RA for the same instruments. Data from the multinational Patient-Reported Outcomes in Employment Study in Rheumatoid Arthritis (RA-PROSE) study were used. Thresholds to determine when patients consider themselves in an "unacceptable work state" were calculated at baseline for 4 instruments assessing presenteeism and for the patient global assessment of RA-related pain. Different approaches derived from the receiver-operating characteristic methodology were used. Accuracy of thresholds to predict AWO throughout 12 months was assessed and previously developed presenteeism thresholds for axSpA were also tested. A total of 104 employed patients were included: 15% of the patients considered themselves in an unacceptable work state, of which 7 (7%) had at least 1 AWO over 12 months. Thresholds of all instruments specifically developed in RA showed good performance vs the external criterion (area under the curve [AUC] > 0.75), except for the Quantity and Quality (QQ) method (AUC 0.62). The available axSpA thresholds were more accurate by reducing overestimation. The final optimal thresholds were Work Productivity and Activity Impairment Questionnaire (WPAI)-presenteeism ≥ 40, QQ method < 97, Workplace Activity Limitations Scale ≥ 0.75, 25-item Work Limitations Questionnaire with modified physical demands scale ≥ 29, and pain intensity ≥ 4. For AWO over 12 months, pain and WPAI performed best in predicting AWO. The final thresholds to assess unacceptable presenteeism for axSpA were also chosen as most accurate for use in RA. In addition, accurate thresholds of pain reflecting unacceptable work state are available.

Efficacy of CycloMesh™ + Ropivacaine in the treatment of uncomplicated inguinal hernia after the Lichtenstein procedure: Results of a prospective multicentric double-blind study

Efficacy of CycloMesh™ + Ropivacaine in the treatment of uncomplicated inguinal hernia after the Lichtenstein procedure: Results of a prospective multicentric double-blind study

Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study.

Evaluate the efficacy and safety ® (olokizumab) in patients with rheumatoid arthritis (RA) in real-world clinical practice, with a targeted assessment of patient report outcomes (PRO) and central sensitization. An open-label observational non-interventional study was conducted, enrolling 183 patients with moderate and severe RA activity. All patients received OKZ 64 mg SC as injections every 4 weeks (Q4W) with methotrexate. The patients' follow-up period was 24 weeks or less. RA activity (DAS28-CRP), pain severity (NRS), patient global assessment (PGA, NRS), functional impairment (NRS), fatigue (FACIT-F), central sensitization (central sensitization inventory, CSI), and symptoms of neuropathic pain (PainDETECT) were evaluated. The study cohort was comprised of 144 patients. And 39 patients were lost to follow-up, refused OKZ treatment, or were not dosed with OKZ for administrative reasons. In 6 months, DAS28-CRP decreased to 3.3 ± 0.9 (p < .001) and statistically significant reductions in pain intensity, PGA, functional impairment, and fatigue were achieved. Pain intensity decreased as early as 2 days after the first OKZ administration (p < .05). The number of patients with CSI >40 in 24 weeks decreased from 71.0% to 21.0% (p < .001), with PainDETECT >18 - from 21.5% to 13.2%. NSAIDs use decreased from 70.8% to 33.8% (р < .001), steroids - from 54.2% to 32.6%. AEs were reported in 14.2% patients, serious events were observed in three patients. OKZ is effective in reducing RA activity and controlling chronic pain related to dysfunction of the nociceptive system.

BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies.

In the absence of axial psoriatic arthritis (axPsA)-specific tools, the BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) are used to assess axial symptoms in patients with PsA. Here, we assessed the performance of BASDAI and ASDAS in patients with PsA. Patients with active PsA in DISCOVER-1 and DISCOVER-2 (ClinicalTrials.gov: NCT03162796 and NCT03158285, respectively) with or without axPsA but with available baseline BASDAI information were analysed; those with investigator-identified axial symptoms and imaging-confirmed sacroiliitis comprised the axPsA cohort. Correlations between BASDAI/ASDAS and clinical variables were assessed with Pearson's coefficient (r). Longitudinal effects of enthesitis (Leeds Enthesitis Index [LEI]), swollen joint count and presence versus absence of axPsA on BASDAI/ASDAS (normalized 0-10 scale) were analysed with mixed models for repeated measures. At baseline in the axPsA (n = 312) and non-axPsA (n = 124) cohorts, BASDAI scores showed no or weak correlation with swollen joint count (0.18-0.20), tender joint count (0.12-0.29), LEI (-0.04 to 0.24) and physician global assessment (0.35-0.43); moderate correlation with fatigue (both -0.56); and strong correlation with patient global assessment of disease activity (0.62-0.69) and patient-reported pain (0.66-0.70). Similar correlations were observed for ASDAS. Axial involvement versus non-involvement was associated with higher BASDAI scores and ASDAS (all β ≥ 0.5), without differences between instruments; longitudinal associations between swollen joint count (β ≤ 0.06)/LEI (β ≤ 0.19) and BASDAI/ASDAS were clinically unimportant. BASDAI and ASDAS performed similarly in patients with active PsA and axial involvement, independent of peripheral disease involvement, supporting their performance in assessing axial disease activity. ClinicalTrials.gov, http://clinicaltrials.gov, NCT03162796 and NCT03158285.

Os Desafios de Estudar o Quinto Sinal Vital: A Dor

Measuring, as determining and evaluating, through measuring instruments or techniques, whatever it may be, is fundamental to all scientifi c investigation. Therefore, various institutions that aim at comprehensive treatment have been concerned with the assessment and measurement of pain in any of its facets or dimensions. In this article on pain, we present its characterization as an enigma, its incidence and its costs; its location in history and the history of its measurement; its defi nition, theory, characterization as the fi fth vital sign and the psychophysical problem that surrounds it; the relationship between pain and survival and its dimensionality; the comorbidities that surround it, the context in which it manifests itself and its characterization as social pain; the possibilities of measuring it, its relationship with individual diff erences and subjectivity. We conclude with what can be understood as global pain assessment and how to diff erentiate pain assessment from pain measurement.Keywords: Pain, measurement, assessment, characterization, incidence

Влияние ноципластической боли на клинические проявления и качество жизни у пациентов с аксиальным псориатическим артритом

The purpose — to determine clinical and laboratory features of axial psoriatic arthritis (AxPsA); to study the impact of nociplastic pain (NP) on the clinical features and quality of life (QoL) in patients with AxPsA. Material and methods. 127 adult patients with psoriatic arthritis (PsA) were included. The number of tender (TJ) and swollen joints (SJ), patient global assessment and severity of pain, C-reactive protein (CRP) were determined. Activity of PsA was assessed with DAPSA, ASDAS, and BASDAI. NP was determined by screening using the CSI and neurologist’s examination. Sacroiliitis (SI) was determined with MRI. QoL was assessed with PsAID-12 and ASAS-HI. Results. SI was found in 60 (47.2%) patients with PsA (AxPsA). The TJ, SJ, CRP, DAPSA, ASDAS were found in higher values and values of CRP above normal, erosive peripheral arthritis and enthesitis were more often found in patients with AxPsA. NP was found in 30 (50%) patients with AxPsA who showed worse pain scores, BASDAI, ASDAS, and QoL. The indicators of TJ, SJ, and CRP in the groups did not differ. Conclusion. SI in PsA is associated with more severe peripheral and laboratory manifestations, but not with more severe pain. Patients with AxPsA with NP have higher rates of disease activity which are associated with degradation of patient reported outcomes including QoL without degradation of inflammation signs. For improving the QoL of patients with PsA it is necessary to study the mechanisms of chronic pain.

Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease.

To evaluate whether the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a responsive instrument in psoriatic arthritis (PsA) and whether it differentiates between axial and peripheral disease activity in PsA. Individuals with PsA initiating therapy in a longitudinal cohort study based in the United States were included. Axial PsA (axPsA), most often also associated with peripheral disease, was defined as fulfillment of the Assessment of Spondyloarthritis international Society axial spondyloarthritis classification criteria or presence of axial disease imaging features. Baseline BASDAI, individual BASDAI items, patient global assessment, patient pain, and Routine Assessment of Patient Index Data 3, and score changes following therapy initiation were descriptively reported. Standardized response means (SRMs) were calculated as the mean change divided by the SD of the change. The mean (SD) baseline BASDAI score at the time of therapy initiation was 5.0 (2.2) among those with axPsA (n = 40) and 4.8 (2.0) among those with peripheral-only disease (n = 79). There was no significant difference in patient-reported outcome scores between the groups. The mean change for BASDAI was similar among axial vs peripheral disease (-0.75 vs -0.83). SRMs were similar across axial vs peripheral disease for BASDAI (-0.37 vs -0.44) and the individual BASDAI items. BASDAI has reasonable responsiveness in PsA but does not differentiate between axPsA and peripheral PsA. (ClinicalTrials.gov: NCT03378336).

ЦЕНТРAЛЬНAЯ СЕНСИТИЗAЦИЯ ПРИ ПСOРИAТИЧЕСКOМ AРТРИТЕ

Introduction. Chronic pain consists of nociceptive, neuropathic and nociplastic components. Nociplastic pain based on central sensitization. Patients with central sensitization may experience severe pain even with no any signs of clinical and laboratory inflammation, and describe it in descriptors of neuropathic pain. The prevalence and influence of central sensitization in clinical and laboratory activity, the development of mood disorders in patients with psoriatic arthritis are not explored well. Aim. To assess the prevalence of central sensitization in patients with psoriatic arthritis, to compare the parameters of patients with and without central sensitization. Materials and methods. We examined 107 patients with psoriatic arthritis: number of tender and swollen joints, severity of pain, patient global assessment, and C-reactive protein were determined. Activity of disease was assessed with Disease activity in psoriatic arthritis, Ankylosing Spondylitis Disease Activity Score. Central sensitization was determined with Central Sensitization Inventory, presence of anxiety and depression - with Hospital Anxiety and Depression Scale. Descriptors of neuropathic pain were determined with Pain Detect Questionnaire. Statistical processing was carried out with Statistics 26.0. Differences were considered significant at p-value &lt; 0.05. Results and discussion. Central sensitization was found in 46 (43%) patients – they had patient global assessment (p=0.004) and severity of pain (p=0.002) in higher values. The C-reactive protein (p=0.423), Disease activity in psoriatic arthritis (p=0.083) did not differ between groups, but the Ankylosing Spondylitis Disease Activity Score (p=0.002) was higher in patients with central sensitization. High prevalence of anxiety (25.2%) and depression (40.2%) was found; more often in patients with central sensitization (p=0.001 and p=0.004). Most of patients described the tactile allodynia, «electric shocks», and burning. Conclusion. Significant contribution of central sensitization to the persistence of pain in patients with psoriatic arthritis was found. The frequency of clinically significant anxiety and depression in patients with psoriatic arthritis was shown, as well as their higher prevalence among patients with central sensitization. Patients with psoriatic arthritis often described pain like neuropathic pain, which can indicate both local damage to the nervous system and the formation of pain sensitization without direct damage to peripheral nerve structures.

Efficacy and safety of curcumin in patients with metabolic phenotype of osteoarthritis: A pilot study

The aim of this study was to assess efficacy and safety of curcumin in metabolic syndrome- associated osteoarthritis (MetS-OA). All patients provided written informed consent. Knee OA was diagnosed according to American College of Rheumatology criteria; MetS was diagnosed according to Russian Scientific Society of Cardiology Guidelines. The study had before-and-after design. The main inclusion criteria were presence of knee OA and MetS, levels of global health assessment and pain assessment more than 50 mm using 0-100 visual analogue scale (VAS). The main outcome was VAS global. The other outcomes were VAS pain, Knee injury and Osteoarthritis Outcome Score (KOOS) consisting of five subscales: pain (KOOS pain), other symptoms (KOOS symptoms), activities in daily living (KOOS ADL), function in sport and recreation (KOOS Sport/Rec) and knee related Quality of life (KOOS QoL). The level of depression was measured using PHQ- 9. For pain, proportion of patients achieving minimal clinically important improvement (MCII) was assessed using the cut-offs of (a) 15 of 100 for absolute improvement and 20% for relative improvement.The treatment consisted of C. longa extract 1000 mg/day for 4 weeks. The assessments were performed on baseline and 4 weeks thereafter. Eighteen women with MetS-OA of the knee were included in the study.At the end of treatment, there were significant improvements in the VAS global scale by an average 33.9 mm (p = 0.001), VAS pain by 25 mm (p = 0.001). There was a trend towards improvement in PHQ-9 by 2.9 (p = 0.05). The mean improvement in KOOS pain was 11 (p = 0.001). KOOS symptoms improved by 9 (p = 0.025), KOOS ADL - by 12.4 (p = 0.001), KOOS Sport/Rec by 10.3 (p = 0.044), and KOOS QOL by 14.4 (p = 0.009). The proportion of patients achieving clinically significant improvement (MCII) were nine (56%) for both global health and pain. There were no adverse events during the study. The findings of this study suggest clinical efficacy and safety of C. Longa in MetS-associated knee OA. There is a need for large controlled studies to confirm these results.

Validating the predictive precision of the dialogue support tool on Danish patient cohorts

Validating the predictive precision of the dialogue support tool on Danish patient cohorts

Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase3 Trial.

A recent phase3, randomized, placebo- and tramadol-controlled trial (56-week treatment/24-week safety follow-up) demonstrated efficacy of tanezumab 10mg in patients with chronic low back pain (CLBP) and a history of inadequate response to standard-of-care analgesics. Here, we report on the clinical meaningfulness of treatment response in this study, focused on secondary measures of pain, interference with daily functions, overall disease status, and satisfaction with treatment. Patients received placebo (up to week16; n = 406), subcutaneously administered (SC) tanezumab 5mg (every 8weeks; n = 407), SC tanezumab 10mg (every 8weeks; n = 407), or orally administered tramadol prolonged-release (100-300mg/day; n = 605) for 56weeks. Patient's global assessment of low back pain (PGA-LBP), Brief Pain Inventory-short form (BPI-sf), Treatment Satisfaction Questionnaire for Medication (TSQM), and modified Patient-Reported Treatment Impact (mPRTI) were assessed at weeks 16 and 56. At week16, significant (p < 0.05) improvements over placebo were evident with tanezumab for the PGA-LBP (10mg) and most BPI-sf (both doses), TSQM (both doses), and mPRTI (both doses) items assessed. Improvements over baseline persisted for the PGA-LBP and BPI-sf at week56. However, the magnitude of improvements was modestly lower at week56 relative to week16. Tramadol did not improve PGA-LBP or BPI-sf scores versus placebo at week16. Most differences between tanezumab and tramadol at week56 did not reach the level of statistical significance for all endpoints. The totality of the evidence as captured by measures of pain, interference with daily function, patient overall assessment of disease status, and satisfaction with treatment demonstrates the clinically meaningful benefit of tanezumab for some patients with CLBP compared with placebo. gov: NCT02528253.

Association of fear assessment in inflammatory rheumatic diseases (FAIR) questionnaire with ankylosing spondylitis quality of life and disease activity in patients with ankylosing spondylitis

Background/Aim: Fear against disease course, treatment, and limitations in family, work, and social life are commonly seen but mostly overlooked by physicians of patients with chronic inflammatory rheumatic diseases. Ankylosing spondylitis (AS) is a chronic inflammatory disease in young adults characterized by limitations in spinal mobility. The Fear Assessment (FAIR) Questionnaire was designed especially for patients with rheumatoid arthritis and spondyloarthritis to assess the level of fear from the patient’s perspective. Here we evaluate the FAIR score in AS patients and its association with disease activity, AS quality of life (ASQoL), depression, anxiety, and fatigue levels.&#x0D; Methods: This cross-sectional study included 79 patients with AS, and disease activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), AS-Disease Activity Score-C reactive protein, and functional status was assessed by Bath Ankylosing Spondylitis Functional Index (BASFI). Patient global assessment of disease and pain were scored on 0–10 cm visual analog scores. All patients completed FAIR and ASQoL questionnaires. The depression and anxiety were evaluated by Hospital Anxiety and Depression Scale (HADS), and fatigue was assessed by Fatigue Severity Scale (FSS).&#x0D; Results: The mean age of AS patients (62% male) was 41.7 (11.3) years. Most of the patients were on biological disease-modifying anti-rheumatic drugs (bDMARDs). The patients’ median BASDAI, ASDAS-CRP, and BASFI were 5.4 (range, 3.8–7.4), 3.83 (1.4), and 4.0 (range, 2.3–6.2), respectively. The overall FAIR, ASQoL, FSS, HADS-depression, and HADS-anxiety scores were 75 (range, 52–91), 9.6 (5.2), 5.4 (range, 4.1–7), 7.7 (4.4) and 9.6 (5.2), respectively. There were statistically significant correlations between disease activity indices and FAIR, ASQoL, FSS, and HADS scores. The FAIR scores significantly correlated with ASQoL, FSS, and HADS scores. The patients with active disease (BASDAI ≥ 4) had significantly higher levels of FAIR, ASQoL, FSS, and HADS. The best cut-off value for the FAIR score of AS patients with moderate to severe disease activity was 50 (AUC: 0.734, 95% CI [0.599–0.870], P = 0.002), with a sensitivity of 89.8%, specificity of 55%, positive likelihood ratio of 1.99, and Youden index of 0.45.&#x0D; Conclusion: This study shows that AS patients face a high level of fear which is associated with higher disease activity, higher risk of mood disorders, and lower quality of life. Physicians should not only focus on the physical improvement of the patient but also handle the fear of patients against their diseases and their treatment. This holistic approach will improve the dialogue between the physician and the patient, which will result in increased compliance with treatment and will raise the quality of care.

Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: post hoc analysis of three randomised clinical trials

ObjectiveEvaluate the effect of upadacitinib on pain outcomes in patients with active psoriatic arthritis (PsA) or ankylosing spondylitis (AS) across 3 randomised trials (SELECT-PsA 1 and 2 for PsA; SELECT-AXIS...

Prediction of outcome after spinal surgery\u2014using The Dialogue Support based on the Swedish national quality register

PurposeTo evaluate the predictive precision of the Dialogue Support, a tool for additional help in shared decision-making before surgery of the degenerative spine.MethodsData in Swespine (Swedish national quality registry) of patients operated between 2007 and 2019 found the development of prediction algorithms based on logistic regression analyses, where socio-demographic and baseline variables were included. The algorithms were tested in four diagnostic groups: lumbar disc herniation, lumbar spinal stenosis, degenerative disc disease and cervical radiculopathy. By random selection, 80% of the study population was used for the prediction of outcome and then tested against the actual outcome of the remaining 20%. Outcome measures were global assessment of pain (GA), and satisfaction with outcome.ResultsCalibration plots demonstrated a high degree of concordance on a group level. On an individual level, ROC curves showed moderate predictive capacity with AUC (area under the curve) values 0.67–0.68 for global assessment and 0.6–0.67 for satisfaction.ConclusionThe Dialogue Support can serve as an aid to both patient and surgeon when discussing and deciding on surgical treatment of degenerative conditions in the lumbar and cervical spine.Level of evidenceI.

A Novel Multi-Dimensional Clinical Response Index Dedicated to Improving Global Assessment of Pain in Patients with Persistent Spinal Pain Syndrome after Spinal Surgery, Based on a Real-Life Prospective Multicentric Study (PREDIBACK) and Machine Learning Techniques.

The multidimensionality of chronic pain forces us to look beyond isolated assessment such as pain intensity, which does not consider multiple key parameters, particularly in post-operative Persistent Spinal Pain Syndrome (PSPS-T2) patients. Our ambition was to produce a novel Multi-dimensional Clinical Response Index (MCRI), including not only pain intensity but also functional capacity, anxiety-depression, quality of life and quantitative pain mapping, the objective being to achieve instantaneous assessment using machine learning techniques. Two hundred PSPS-T2 patients were enrolled in the real-life observational prospective PREDIBACK study with 12-month follow-up and received various treatments. From a multitude of questionnaires/scores, specific items were combined, as exploratory factor analyses helped to create a single composite MCRI; using pairwise correlations between measurements, it appeared to more accurately represent all pain dimensions than any previous classical score. It represented the best compromise among all existing indexes, showing the highest sensitivity/specificity related to Patient Global Impression of Change (PGIC). Novel composite indexes could help to refine pain assessment by informing the physician’s perception of patient condition on the basis of objective and holistic metrics, and also by providing new insights regarding therapy efficacy/patient outcome assessments, before ultimately being adapted to other pathologies.

Comparison of Thoracic Epidural Analgesia and Thoracic Paravertebral Block Applications in the Treatment of Acute Pain After Thoracotomy in Geriatric Patients.

BackgroundThoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) are commonly used in geriatric patients for pain management after thoracotomy. In this study, we aimed to investigate the effect of TEA and TPVB on postoperative analgesia in geriatric patients who underwent thoracotomy.MethodologyPostoperative analgesia follow-up files of patients over 65 years of age who underwent thoracotomy were analyzed retrospectively. Patient’s demographic data, diagnosis, type of surgery, postoperative 24-hour mean arterial pressure (MAP), heart rate, respiratory rate, peripheral oxygen saturation, static/dynamic visual analog scale (VAS) scores, need for additional analgesics, global pain assessment, and side effects such as nausea, vomiting, hypotension, bradycardia, and respiratory depression were examined. The patients were divided into two groups: those treated with TEA (Group 1) and those treated with TPVB (Group 2).ResultsThere was no statistically significant difference between the groups in terms of demographic data (p > 0.05). MAP in the TEA group was statistically significantly lower than in the second and sixth-hour TPVB group (p = 0.008, p < 0.001). VAS static scores in the TEA group were statistically significantly lower at 30 minutes (p = 0.001), and at one, two, six, twelve, and twenty-four hours compared to the TPVB group (p < 0.001, except at 30 minutes). VAS dynamic scores were statistically significantly lower in the TEA group at 30 minutes, and at one, two, six, twelve, and twenty-four hours compared to the TPVB group (p < 0.001). There was no statistically significant difference between the groups in terms of nausea, vomiting, hypotension, and bradycardia (p > 0.05). The use of additional analgesics in the TEA group was statistically significantly lower than in the TPVB group (p < 0.001).ConclusionsMore effective postoperative analgesia results with stable hemodynamic conditions were observed in geriatric patients who underwent TEA for thoracotomy compared to TPVB. Regarding side effects, although there was a lower incidence in TPVB, this was not statistically significant when compared to TEA. TEA, as a component of the multimodal analgesia approach, can be accepted as a safe and effective method in the elderly patient group who underwent thoracotomy.

Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis

BackgroundPeficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety in the treatment of patients with rheumatoid arthritis (RA). This study evaluated the effect of peficitinib on patient- and physician-reported outcomes in Asian patients with RA and an inadequate response to prior disease-modifying antirheumatic drugs (DMARDs).MethodsPatients from two randomized, placebo-controlled, double-blind, phase 3 trials (RAJ3 and RAJ4) received once-daily peficitinib 100 mg, peficitinib 150 mg, or placebo, alone or in combination with DMARDs (RAJ3), or in combination with methotrexate (RAJ4). Mean changes in Work Productivity and Activity Impairment (WPAI) questionnaire domain scores from baseline, and percentages of patients achieving minimal clinically important differences (MCIDs) for patient- and physician-reported outcomes (WPAI, Health Assessment Questionnaire – Disability Index [HAQ-DI], and Subject’s Global Assessment of Pain [SGAP]), and Physician’s Global Assessment of disease activity (PGA) were evaluated at weeks 4, 8, 12, and 12/early termination (ET).ResultsData from 1025 patients were analyzed. At week 12/ET in both studies, patients who received peficitinib 100 mg or 150 mg reported significantly improved WPAI domain scores from baseline (except for absenteeism in RAJ4) compared with placebo (both doses, p<0.05). A higher proportion of peficitinib- versus placebo-treated patients achieved MCID in WPAI, HAQ-DI, SGAP, and PGA in studies RAJ3 and RAJ4. Significant differences with peficitinib versus placebo were evident in both studies as early as week 4 in HAQ-DI (peficitinib 150 mg only), SGAP, and PGA, and week 8 in WPAI loss of work productivity and daily activity impairment. At week 12/ET, significantly higher proportions of patients receiving peficitinib versus placebo achieved MCID in HAQ-DI, SGAP, PGA, and WPAI domains of presenteeism (RAJ3 only), loss of work productivity (RAJ3 only), and daily activity impairment (p<0.05 for all comparisons).ConclusionsPeficitinib 100 mg or 150 mg administered daily over 12 weeks resulted in clinically meaningful improvements in outcomes that are important to RA patients, including pain, physical function, and work productivity and activity. These observations were reinforced through similar improvements in physicians’ rating of disease activity.Trial registrationRAJ3: ClinicalTrials.gov, NCT02308163, registered 4 December 2014.RAJ4: ClinicalTrials.gov, NCT02305849, registered 3 December 2014.

Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic inflammatory disease with a high burden for patients and limited existing therapeutic options. To evaluate the efficacy and safety of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin 17A and 17F in individuals with moderate to severe HS. This phase 2, double-blind, placebo-controlled randomized clinical trial with an active reference arm was performed from September 22, 2017, to February 21, 2019. The study included a 2- to 4-week screening period, a 12-week treatment period, and a 20-week safety follow-up. Of 167 participants screened at multiple centers, 90 were enrolled. Eligible participants were 18 to 70 years of age with a diagnosis of moderate to severe HS 12 months or more before baseline. Participants with HS were randomized 2:1:1 to receive bimekizumab (640 mg at week 0, 320 mg every 2 weeks), placebo, or reference arm adalimumab (160 mg at week 0, 80 mg at week 2, and 40 mg every week for weeks 4-10). The prespecified primary efficacy variable was the proportion of participants with a 50% or greater reduction from baseline in the total abscess and inflammatory nodule count with no increase in abscess or draining fistula count (Hidradenitis Suppurativa Clinical Response [HiSCR] at week 12. Exploratory variables included proportion achieving a modified HiSCR with 75% reduction of HiSCR criteria (HiSCR75) or a modified HiSCR with 90% reduction of HiSCR criteria (HiSCR90), change in Patient's Global Assessment of Pain, and Dermatology Life Quality Index total scores. Eighty-eight participants received at least 1 dose of study medication (61 [69%] female; median age, 36 years; range, 18-69 years). Seventy-three participants completed the study, including safety follow-up. Bimekizumab demonstrated a higher HiSCR rate vs placebo at week 12 (57.3% vs 26.1%; posterior probability of superiority equaled 0.998, calculated using bayesian analysis). Bimekizumab demonstrated greater clinical improvements compared with placebo. Improvements in the International Hidradenitis Suppurativa Severity Score (IHS4) were seen at week 12 with bimekizumab (mean [SD] IHS4, 16.0 [18.0]) compared with placebo (mean [SD] IHS4, 40.2 [32.6]). More bimekizumab-treated participants achieved positive results on stringent outcome measures compared with placebo. At week 12, 46% of bimekizumab-treated participants achieved HiSCR75 and 32% achieved HiSCR90, whereas 10% of placebo-treated participants achieved HiSCR75 and none achieved HiSCR90; in adalimumab-treated participants, 35% achieved HiSCR75 and 15% achieved HiSCR90. One participant withdrew because of adverse events. Serious adverse events occurred in 2 of 46 bimekizumab-treated participants (4%), 2 of 21 placebo-treated participants (10%), and 1 of 21 adalimumab-treated participants (5%). In this phase 2 randomized clinical trial, bimekizumab demonstrated clinically meaningful improvements across all outcome measures, including stringent outcomes. Bimekizumab's safety profile was consistent with studies of other indications, supporting further evaluation in participants with HS. ClinicalTrials.gov Identifier: NCT03248531.

AB0529 CHARACTERIZATION OF REMISSION IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH UPADACITINIB: POST-HOC ANALYSIS FROM TWO PHASE 3 TRIALS

AB0529 CHARACTERIZATION OF REMISSION IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH UPADACITINIB: POST-HOC ANALYSIS FROM TWO PHASE 3 TRIALS

POS0907 EFFECT OF UPADACITINIB ON REDUCING PAIN IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO NONSTEROIDAL ANTI-INFLAMMATORY DRUGS

POS0907 EFFECT OF UPADACITINIB ON REDUCING PAIN IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO NONSTEROIDAL ANTI-INFLAMMATORY DRUGS