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Christine de la Loge,1 Fatoumata Fofana,2 Paul Williams,1 Sarah Rusch,3 Marita Stevens,4 Jane Scott5 1Patient-Centered Outcomes, Mapi (an ICON Plc. company), Lyon, France; 2Patient-Centered Outcomes, Mapi (an ICON Plc. company), Leiden, the Netherlands; 3Statistical Decisions and Sciences, Janssen Biostatistics Research & Development, Beerse, B-2340, Belgium; 4Global Clinical Development Infectious Diseases, Janssen Research & Development, Beerse, B-2340, Belgium; 5Janssen Global Services LLC, High Wycombe, UKCorrespondence: Christine de la Loge Tel +33 7 85 61 78 59Email cdelaloge@outlook.frPurpose: PRESORS ClinRO completed by clinicians and ObsRO completed by caregivers were developed to characterize the clinical course of respiratory syncytial virus (RSV) infection. This study describes preliminary analysis of PRESORS’ measurement properties using clinical trial data.Patients and Methods: PRESORS ClinRO and ObsRO data were collected in a 28-day randomized, double-blind, Phase 1b trial of JNJ-53718678 or placebo in infants and children ≤ 24 months of age treated for RSV infection in hospitals. PRESORS data were scored and key psychometric properties of scores were evaluated, including ability to discriminate between known groups and to detect change over time. Time to resolution of RSV signs was explored using two responder definitions.Results: Daily completion rates for PRESORS ClinRO and ObsRO were high for the 44 children in the study (median: 100% and 93%, respectively). Large floor effects were observed at baseline for signs of severe RSV infection that were either absent (cyanosis, fever, apnea) or rarely reported (reduced urination/dehydration, vomiting). Implausible ObsRO ratings suggested some caregivers could not accurately measure heart rate. Known-group validity was confirmed: children in poor health based on baseline ClinRO had mean baseline composite scores that were significantly worse for both ObsRO (p=0.001) and ClinRO (p< 0.001) compared to those with better overall health. ObsRO (p=0.009) and ClinRO (p< 0.001) composite scores were responsive to change in overall health status from baseline to Day 3. Mean scores for RSV sign dimensions decreased rapidly from baseline to Day 7 except for coughing and sleep ratings by caregivers. Time to recovery varied greatly depending on definitions used.Conclusion: PRESORS ClinRO and ObsRO can inform endpoints and enable monitoring the clinical course of RSV in pediatric trials. Improved alignment between ClinRO and ObsRO and revisions ensuring caregivers can assess all signs will be addressed in revised PRESORS.Keywords: psychometric validation, clinician-reported outcomes, observer-reported outcomes, pediatrics, respiratory syncytial virus

Established post-menopausal osteoporosis (PMO) has serious consequences on health related quality of life (HRQL), as long-term back and joint pain can severely limit normal activities. The quality of life questionnaire in osteoporosis (QUALIOST), a self-administered module consisting of 23 questions which complements the SF-36, was specifically designed to evaluate the repercussions of PMO on patient HRQL. The QUALIOST was developed simultaneously in French and English after discussion with 45 patients. A validation study in France and the UK included 140 women with PMO, with at least one osteoporotic vertebral fracture. Patients completed the SF-36 and QUALIOST twice, 7 days apart. Factorial analysis revealed a physical and emotional component. Three scores were calculated: physical repercussions (10 items), emotional repercussions (13 items) and the global score (23 items). Internal reliability and stability over time were excellent. Concurrent validity with the SF-36 physical and mental fields was satisfactory. A deterioration in clinical state, as measured by pain severity, hospital admission and walking stick use, increased the repercussions on HRQL for all three scores, demonstrating the clinical validity of the questionnaire. The QUALIOST, combined with the SF-36, is a valid rating scale for measuring HRQL in clinical trials for established PMO, providing both general and specific data on the effects of PMO on patient HRQL. [ABSTRACT FROM AUTHOR]

Le bimekizumab (BKZ) est un anticorps monoclonal IgG1 qui inhibe de manière sélective l'IL-17F en plus de l'IL-17A. Dans les études de phase III dans la spondyloarthrite axiale (axSpA), BE MOBILE 1 et 2, le BKZ a démontré des améliorations durables des principaux symptômes jusqu'à 52 semaines (S) chez des patients (pts) atteints d'axSpA non radiographique (nr-axSpA) et radiographique (r-axSpA) [1]. Dans BE MOBILE 1 (nr-axSpA ; NCT03928704) et BE MOBILE 2 (r-axSpA ; NCT03928743), les pts ont été randomisés sous BKZ 160 mg/4S ou sous placebo (PBO) ; à partir de S16, tous les pts ont reçu BKZ 160 mg/4S. À S52, les pts ayant terminé l'une ou l'autre des études pouvaient entrer dans BE MOVING (NCT04436640), l'étude d'extension en ouvert en cours. Nous présentons les valeurs moyennes et les variations par rapport à l'inclusion (CfB) de la douleur rachidienne totale et nocturne, de la raideur matinale (moyenne des questions Q5 et Q6 du BASDAI) et de la fatigue (BASDAI Q1 et FACIT-fatigue), jusqu'à S104 (imputation multiple). Nous présentons également la proportion de pts ayant atteint des scores de douleur rachidienne nocturne totale : < 2 (indiquant une douleur rachidienne minimale [score= 1] ou nulle [score = 0]) et < 4 sur la base des critères d'inclusion de BE MOBILE 1 et 2 (douleur rachidienne ≥ 4 selon BASDAI Q2). Sont enfin présentés les répondeurs FACIT-Fatigue (proportion atteignant une augmentation ≥ 8 points par rapport à l'inclusion, chez les pts ayant un score initial ≤ 44) à S104 (imputation des non-répondeurs [NRI] et cas observés [CO]). Sur 254 pts nr-axSpA/332 pts r-axSpA initialement randomisés en BKZ ou PBO dans BE MOBILE 1/2, respectivement, 494 (84,3 %) pts sont entrés dans BE MOVING à S52. En juillet 2023, 189 pts nr-axSpA/267 pts r-axSpA avaient terminé S104. Les symptômes à l'inclusion étaient comparables entre les groupes de traitement (Figure 1). Les améliorations par rapport à l'inclusion à S52 ont été maintenues jusqu'à S104 pour les scores de douleur rachidienne totale et nocturne et de raideur matinale (CfB pour tous : –4,2 à S52, –4,3 à S104 ; Figure 1). Les résultats étaient similaires pour la fatigue BASDAI (CfB : –3,1 à S52 ; –3,4 à S104). L'amélioration des scores FACIT-Fatigue s'est maintenue tout au long de l'étude (CfB : +9,9 à S52 et à S104 ; Figure 1). De S52 à S104, > 50 % des pts ont atteint des scores de douleur rachidienne totale et nocturne < 4, et > 25 % et > 35 % ont atteint des scores de douleur rachidienne totale et nocturne < 2, respectivement (NRI et OC ; Figure 2). Plus de 50 % des pts ont été considérés comme ayant répondu au test FACIT-Fatigue de S52 à S104 (Figure 2). Les résultats étaient similaires chez les pts atteints de nr-/r-axSpA. Les résultats à 2 ans de traitement par BKZ ont montré des améliorations durables de la douleur rachidienne, de la raideur matinale et de la fatigue chez les pts atteints de nr-/r-axSpA, soulignant le bénéfice à plus long terme de BKZ sur les symptômes cliniques. [ABSTRACT FROM AUTHOR]

Abstract Background The QUALIOST® was designed for use with the SF-36 to measure established osteoporosis-specific quality of life (QoL). The reliability (internal consistency and test-retest) and validity of the questionnaire were established in a stand-alone psychometric validation study. The objective of this paper is to provide additional information on the instrument's responsiveness using clinical trial data, along with the reliability and validity of translated versions. Methods The Spinal Osteoporosis Therapeutic Intervention (SOTI) was an international clinical trial comparing strontium ranelate to placebo on the occurrence of new vertebral fracture in patients with postmenopausal osteoporosis. QoL was a secondary endpoint, assessed using the SF-36 and QUALIOST® at baseline and every six months, with the main analysis at 3-year follow-up. Questionnaire acceptability, analysis of the hypothesised structure, internal consistency reliability and responsiveness to clinical change over time were assessed at the 3-year follow up. Results 1592 patients from 11 countries completed at least one QoL questionnaire. The psychometric properties of the questionnaires were assessed on cross-sectional (N = 1486) and longitudinal (N = 1288) data. Item discriminant validity of the QUALIOST® was excellent, as was item convergent validity, with 100% of item-scale correlations being above the 0.40 level. Internal consistency reliability was also extremely good, with high Cronbach's alpha scores above the 0.70 benchmark. Responsiveness results were consistent for all QUALIOST® scores, indicating that greater decreases in QoL corresponded to greater numbers of fractures experienced. QUALIOST® scores also differed according to the type of fracture suffered. This was demonstrated by increased effect sizes for more severe vertebral fractures (clinical vertebral and painful vertebral). In comparing responsiveness, the QUALIOST® scores were generally more consistent than those of the SF-36. Most notably, the QUALIOST® was more responsive with regard to painful vertebral fractures than the SF-36. Conclusion The QUALIOST® is a reliable and valid tool for measuring QoL in postmenopausal osteoporotic women. Being available in several validated language versions, it is ready to be used in a variety of settings, including international clinical trials.

An abstract of the article "Strontium Ranelate Prevents Quality of Life Impairment," by P. Marquis, C. Roux, C. de la Loge, M. Diaz-Curiel, C. Cormier, G. Isaia, J. Badurski, J. Wark and P.J. Meunier is presented.

Objective: Efficacy, tolerability, and behavioral/executive functioning during long-term adjunctive brivaracetam treatment were assessed in pediatric patients with focal-onset seizures (FOS) with/without cognitive/learning comorbidities (CLC)., Methods: Post hoc analysis of a phase 3 open-label follow-up trial (N01266/NCT01364597). Patients with FOS (<16 years at core trial entry; direct enrollers ≥4-<17 years) received ≤5 mg/kg/day brivaracetam (≤200 mg/day). Subgroup analyses were performed for patients with and without ongoing CLC at baseline., Results: Patients with CLC (84/185 [45.4 %]) had longer epilepsy duration and higher number of prior antiseizure medications. Kaplan-Meier-estimated brivaracetam retention at 1, 3, and 5 years was 75.0 %/78.2 %, 61.9 %/61.9 %, and 52.2 %/53.3 % in patients with/without CLC. Efficacy assessments (patients >2 years of age) showed numerically lower median percent reduction in FOS frequency/28 days (43.8 %/74.1 % [n = 63/60]), 50 % responder rates for FOS (46.0 %/61.7 % [n = 63/60]), and ≥12-month continuous freedom from all seizures (31.7 %/55.9 % [n = 60/68 patients with ≥12 months treatment]) in patients with/without CLC. Treatment-emergent adverse events were reported in 94.0 %/95.0 % of patients with/without CLC (serious: 33.3 %/27.7 %; drug-related: 31.0 %/33.7 %). From baseline to last evaluation, most patients with/without CLC had no shift in T-score category for each Achenbach Child Behavior Checklist (CBCL) 1.5-5 syndrome (≥50.0 %/≥72.2 %), CBCL 6-18 syndrome (≥66.0 %/≥69.1 %), and Behavior Rating Inventory of Executive Function scale (≥66.7 %/≥69.0 %)., Conclusions: These data indicate that brivaracetam could be an efficacious and well-tolerated treatment option for pediatric patients with FOS with and without CLC. Behavior and executive functioning were generally stable or slightly improved in patients with and without CLC., Competing Interests: Declaration of Competing Interest Dimitrios Bourikas, Juliane Koch, Svetlana Dimova, Sami Elmoufti, and Brian Moseley are salaried employees of UCB and have received UCB stocks from their employment. Christine de la Loge (PCOM Analytics, Avallon, France) is contracted by UCB. Lieven Lagae received grants and is a consultant and/or speaker for Eisai, Epihunter, GW Pharma, LivaNova, Novartis, Shire, Takeda/Ovid, and UCB., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: To assess the effect of bimekizumab on pain, morning stiffness, and fatigue in patients with nonradiographic and radiographic axial spondyloarthritis (axSpA) in the phase III BE MOBILE studies (ClinicalTrials.gov: NCT03928704 and NCT03928743)., Methods: Patients were randomized to bimekizumab 160 mg or placebo every 4 weeks; and all patients received bimekizumab from week 16. Patients reported spinal pain, peripheral pain, morning stiffness, and fatigue to week 52. Total and nocturnal spinal pain were each assessed on a 0-10 numerical rating scale (NRS). Individual Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) items (0-10-point NRS) assessed peripheral arthritis pain (question [Q] 3), enthesitis pain/discomfort (Q4), morning stiffness (mean of Q5 and Q6), and fatigue (Q1). Functional Assessment of Chronic Illness Therapy Fatigue subscale score (FACIT-Fatigue) is also reported., Results: At week 16, bimekizumab-treated patients reported lower mean nocturnal spinal pain, total spinal pain, and BASDAI scores (nominal except for nocturnal spinal pain; all P ≤ 0.001), as well as higher FACIT-Fatigue scores (nominal P < 0.05) vs placebo, indicating improved symptom levels. Improvements continued to week 52 in continuous bimekizumab-treated patients and in placebo-bimekizumab switchers. A higher proportion of bimekizumab- vs placebo-randomized patients achieved increasingly stringent thresholds for low spinal and peripheral pain at week 16; this was sustained or improved at week 52. Results were similar for morning stiffness and fatigue. At week 52, over half of patients were considered FACIT-Fatigue responders (≥ 8-point increase in score)., Conclusion: Bimekizumab treatment led to rapid improvements in levels of pain and morning stiffness. Substantial improvements were seen in all domains across the full disease spectrum of axSpA and continued to week 52.

Objectives: To evaluate long-term efficacy, safety, and tolerability, including behavior and executive functioning, during adjunctive lacosamide (LCM) treatment in pediatric patients (≥1 month to <18 years of age) with focal-onset or generalized seizures enrolled in 2 open-label, long-term follow-up trials., Methods: Two open-label extension trials (SP848: NCT00938912; EP0034: NCT01964560) were conducted in pediatric patients who had participated in previous trials of adjunctive LCM (SP0847/NCT00938431; SP0966/NCT01969851; EP0060/NCT02710890; SP0967/NCT02477839; SP0969/NCT01921205); SP848 also directly enrolled eligible pediatric patients who had not previously participated in a clinical trial of LCM. Outcomes included retention, efficacy, and safety/tolerability. Patient improvement was assessed with Clinician's and Caregiver's Global Impression of Change scale. Behavior and emotional function was assessed with Achenbach Child Behavior Checklist (CBCL) and executive functioning was assessed with Behavior Rating Inventory of Executive Function® (BRIEF)., Results: The pooled dataset from both trials included 905 patients (851 in the focal-onset seizure population and 47 in the generalized seizure population). In the overall population, Kaplan-Meier-estimated 1-year retention was 80 %. From baseline to the end of the treatment period, patients in the focal-onset seizure population had a median percent reduction in focal-onset seizure frequency per 28 days of 60.4 %, 55.4 % of patients were 50 % responders, and 40.8 % of patients were 75 % responders. In patients with ≥12 months of LCM treatment, ≥12 month seizure freedom during the LCM treatment period was achieved by 29.9 % of patients in the focal-onset seizure population (median duration of first ≥12-month seizure-free interval: 641 days) and 24.4 % of patients in the generalized seizure population (median duration of first ≥12-month seizure-free interval: 665 days). Improvement during LCM treatment was reported in >75 % of patients by both physicians and caregivers. Treatment-emergent adverse events (TEAEs) were reported by 749 (82.8 %) patients, most commonly pyrexia (18.9 %), upper respiratory tract infection (18.6 %), nasopharyngitis (16.2 %), vomiting (15.7 %), and somnolence (11.8 %). The most common drug-related TEAEs were somnolence (8.5 %), dizziness (7.6 %), and vomiting (5.4 %). Behavioral and emotional function was generally stable in patients 1.5-5 years of age and slightly improved in patients ≥6 years of age, and executive functioning was stable in patients <5 years of age and generally slightly improved in patients 5-18 years of age., Conclusions: In this analysis of a large patient pool from 2 open-label trials, long-term adjunctive LCM was efficacious and generally well tolerated in children with epilepsy and focal-onset or generalized seizures. Behavior and executive functioning were generally stable without observable worsening during long-term adjunctive LCM treatment., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MK Farkas and I Makedonska report no conflicts of interest. C Beller, D Bourikas, S Dimova, F Floricel, C McClung, and B Moseley are salaried employees of UCB Pharma and have received UCB Pharma stocks from their employment. C de la Loge (PCOM Analytics, Avallon, France) is contracted by UCB Pharma. S Therriault was an employee of UCB Pharma at the time the trials were conducted. JE Pina-Garza has served as a consultant and speaker for Catalyst Pharmaceuticals, Jazz Pharmaceuticals, Marinus Pharmaceuticals, Neurelis, SK Life Science, and UCB Pharma; and received payment from Elsevier for services as book editor., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Fatigue is an important symptom for most patients with axial spondyloarthritis (axSpA). The FACIT-Fatigue is a 13-item patient-reported outcome (PRO) instrument that has been used in axSpA clinical trials to measure fatigue severity and impact on daily activities. However, the psychometric properties of the FACIT-Fatigue are not fully evaluated across the entire spectrum of axSpA including non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). This study determined: (1) the psychometric properties of the FACIT-Fatigue in nr-axSpA, r-axSpA, and the broad axSpA population and (2) FACIT-Fatigue scores representing meaningful within-patient change (MWPC), meaningful between-group differences, and cross-sectional severity bands., Methods: Data from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1; N = 254) and r-axSpA (BE MOBILE 2; N = 332) were analyzed pooled and separately to assess the psychometric properties of the FACIT-Fatigue. MWPC and meaningful between-group difference estimates were derived using anchor-based and distribution-based methods. Cross-sectional fatigue severity bands were estimated using logistic regression analysis., Results: The FACIT-Fatigue presented good internal consistency, adequate convergent and known-groups validity, and was sensitive to change over time across the full axSpA spectrum. A 5-11-point increase in FACIT-Fatigue score was estimated to represent a MWPC, with an 8-point increase selected as the responder definition. A 2.14-5.34-point difference in FACIT-Fatigue score change over a 16-week period was estimated to represent a small-to-medium meaningful between-group difference. FACIT-Fatigue score severity bands were defined as: none or minimal (>40), mild (>30 to ≤40), moderate (>21 to ≤30), and severe (≤21)., Conclusions: These findings support the use of the FACIT-Fatigue as a fit-for-purpose measure to assess fatigue-related treatment benefit in axSpA clinical trials. The proposed score estimates and thresholds can guide FACIT-Fatigue score interpretation across the full axSpA spectrum., Trial Registration: ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic., Clinicaltrials: gov/ct2/show/NCT03928704 ., Clinicaltrials: Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic., Clinicaltrials: gov/ct2/show/NCT03928743 ., (© 2024. The Author(s).)

Objective: To assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2., Methods: Patients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL)., Results: At Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p<0.001), and numerically greater improvements in MOS-Sleep-R Index II and WPAI:axSpA scores. Higher proportions of bimekizumab-randomised versus placebo-randomised patients at Week 16 achieved increasingly stringent thresholds for improvements in BASFI (0 to ≤4), and thresholds for meaningful improvements in SF-36 PCS (≥5-point increase from baseline) and ASQoL (≥4-point decrease from baseline). Responses were sustained or further improved to Week 52, where 60%-70% of bimekizumab-treated patients achieved BASFI ≤4 and meaningful improvements in SF-36 PCS and ASQoL, regardless of whether originally randomised to bimekizumab or placebo., Conclusion: Bimekizumab treatment led to early improvements in physical function, sleep, work productivity and overall HRQoL at Week 16 in patients across the full axSpA disease spectrum. Improvements were sustained to Week 52., Trial Registration Numbers: NCT03928704; NCT03928743., Competing Interests: Competing interests: MD: Educational grant from Pfizer paid to institution; consulting fees (eg, advisory boards) from Amgen and UCB Pharma; VN-C: Speakers bureau for AbbVie, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie and Novartis; AB: Research grants from AbbVie; speakers honoraria and consultation fees from AbbVie, Galapagos, Pfizer, Novartis and UCB Pharma; KG: Speakers bureau for AbbVie, Eli Lilly, Novartis and UCB Pharma; consultant for AbbVie, Eli Lilly, Novartis and UCB Pharma; grant/research support from AbbVie, Gilead, Eli Lilly, Novartis and UCB Pharma; LSG: Grants from Novartis and UCB Pharma paid to institution; consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma; CdlL: Consultant to UCB Pharma; TV, UM and MFM: Employees of UCB Pharma; CF and VT: Employees and shareholders of UCB Pharma; AD: Speakers bureau for Janssen, Novartis, and Pfizer; consultant for AbbVie, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma; MR: Speakers bureau for AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; consultant of AbbVie, Eli Lilly, Novartis and UCB Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess how achievement of increasingly stringent clinical response criteria and disease activity states at week 52 translate into changes in core domains in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA)., Methods: Patients in BE MOBILE 1 and 2 achieving different levels of response or disease activity (Assessment of SpondyloArthritis International Society (ASAS) and Ankylosing Spondylitis Disease Activity Score (ASDAS) response criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50)) at week 52 were pooled, regardless of treatment arm. Associations between achievement of these endpoints and change from baseline (CfB) in patient-reported outcomes (PROs) measuring core axSpA domains, including pain, fatigue, physical function, overall functioning and health, and work and employment, were assessed., Results: Achievement of increasingly stringent clinical efficacy endpoints at week 52 was generally associated with sequentially greater improvements from baseline in all PROs. Patients with nr-axSpA achieving ASAS40 demonstrated greater improvements (CfB) than patients who did not achieve ASAS40 but did achieve ASAS20, in total spinal pain (-5.3 vs -2.8, respectively), Functional Assessment of Chronic Illness-Fatigue subscale (12.7 vs 6.7), Bath Ankylosing Spondylitis Function Index (-3.9 vs -1.8), European Quality of Life 5-Dimension 3-Level Version (0.30 vs 0.16), Work Productivity and Activity Impairment-axSpA presenteeism (-35.4 vs -15.9), overall work impairment (-36.5 vs -12.9), activity impairment (-39.0 vs -21.0) and sleep (9.0 vs 3.9). Results were similar for ASDAS and BASDAI50. Similar amplitudes of improvement were observed between patients with nr-axSpA and r-axSpA., Conclusions: Patients treated with bimekizumab across the full axSpA disease spectrum, who achieved increasingly stringent clinical response criteria and lower disease activity at week 52, reported larger improvements in core axSpA domains., Competing Interests: Competing interests: VN-C: Speakers’ bureau for AbbVie, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie and Novartis; SR: Grants from AbbVie, Galapagos, MSD, Novartis, Pfizer and UCB Pharma; consultancy from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi and UCB Pharma; AD: Speakers’ bureau for Janssen, Novartis and Pfizer; consultant for AbbVie, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB Pharma; grant/research support from AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer, and UCB Pharma; PJM: Research grants from AbbVie, Acelyrin, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, and UCB Pharma; consultancy fees from AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma, Takeda, UCB Pharma, and Ventyx; speakers’ bureau for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; MR: Speakers’ bureau for AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; consultant of AbbVie, Eli Lilly, Novartis and UCB Pharma; CdlL: Consultant to UCB Pharma; CF, VT: Employees and shareholders of UCB Pharma; MFM, UM: Employees of UCB Pharma; JK: Consulting fees from Alvotech Swiss AG, Boehringer Ingelheim GmbH, Organon, Ridgeline Discovery, Scipher Medicine, Samsung Bioepis, Sandoz and UCB Pharma; grant/research support paid to institution from Gilead and Novartis; MM: Consultancy fees from AbbVie, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, BMS and UCB Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)