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The content of supervised group exercise (SGE) for axial spondyloarthritis (axSpA) has hardly changed in recent decades, despite new evidence-based insights to improve SGE quality. This pilot implementation study evaluated the effects and feasibility of enhancements in axSpA-specific SGE in four regions in the Netherlands. The implemented enhancements included: more high-intensity aerobic exercise; exercise personalization with periodic assessments; and patient education on home exercise. The implementation strategy included a one-day supervisor training course and telephone support. To evaluate effects, aerobic capacity [Six-Minute Walk Test (6MWT)], physical functioning [Ankylosing Spondylitis Performance-based Improvement (ASPI); improved/not improved], health status [Assessment of SpondyloArthritis international Society Health Index (ASAS HI) questionnaire], and home exercise engagement [Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH)] were assessed at baseline and after one year in 60 participants. Changes were analysed with the Wilcoxon signed-rank test. To evaluate feasibility, a survey of participants and semi-structured interviews with four SGE supervisors assessed uptake and satisfaction with the enhancements. Aerobic capacity increased significantly and 35% of participants improved functioning, whereas health status and home exercise engagement did not change. The participants' survey and supervisors' interviews showed that high-intensity aerobic exercise was implemented successfully, exercise personalization and periodic assessments were implemented partially, and patient education was not implemented at all. Most participants were satisfied with the changes. After this pilot implementation, SGE enhancements were only partially implemented. Nevertheless, aerobic capacity improved significantly and satisfaction with accomplished changes was high. Nationwide implementation would require adaptations to improve feasibility. [ABSTRACT FROM AUTHOR]

The European Commission (EC) has proposed to redefine 'unmet medical need' to steer pharmaceutical innovation and link the definition to incentives and regulatory tools and procedures. A multistakeholder meeting of the Regulatory Science Network Netherlands (RSNN) discussed the impact of this proposal. Four principles were highlighted (flexibility, feasibility, fairness, and sensitivity to risk) that were not considered sufficiently addressed. Concerns were raised about whether innovation would be incentivised, given the diverse and complex reasons why areas of unmet medical need may remain unaddressed. A more high-level definition of unmet medical need that gives guidance but allows for specification for specific uses throughout the medicine lifecycle was generally preferred. As the legislative process unfolds, stakeholder engagement will be essential to refine the definition to achieve the intended policy goals., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objective: To evaluate the cost-effectiveness of longstanding personalized exercise therapy compared with usual care in people with rheumatoid arthritis (RA) and severe functional disability., Method: In this cost-utility analysis of a randomized controlled trial (n = 215), with 1 year follow-up, the study population comprised individuals with RA and reported severe difficulties in performing basic daily activities. Assessments were at baseline, 12, 26, and 52 weeks, with measurements of costs including medical and non-medical costs as recorded by patients and healthcare providers. Quality-adjusted life-years (QALYs) were estimated using the EuroQol 5 dimensions 5 levels (EQ-5D-5L) and EuroQol Visual Analogue Scale (EQ-VAS). Costs and QALY differences were analysed according to the intention-to-treat principle using cost-effectiveness acceptability curves., Results: The 1 year societal costs were non-significantly in favour of the usual care group, with a small difference of €180 [95% confidence interval (CI) €-4493 to €4852]. The QALYs were non-significantly in favour of the intervention group, by 0.02 according to the EQ-5D-5L (95% CI -0.05 to 0.09) and by 0.04 according to the EQ-VAS (95% CI 0.00 to 0.08). For a willingness-to-pay threshold of €50 000 per QALY, the intervention was the cost-effective strategy with 60% certainty., Conclusion: This economic evaluation showed no clear economic preference for either group, as the intervention costs were higher in the intervention group, but partly compensated by other cost savings and improved QALYs. Despite severe RA, patients had better clinical outcomes compared with usual care, suggesting no economic reasons to refrain from exercise therapy., Trial Registration Number: Netherlands Trial Register NL8235, included in the International Clinical Trial Registry Platform (ICTRP) (https://trialsearch.who.int/Trial2.aspx?TrialID=NL8235).

Objective: To assess the duration, frequency, and content of individual physical therapy (PT) in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA)., Method: In this cross-sectional study, an electronic questionnaire aimed at people with RA and axSpA was distributed through various communication channels of the Dutch Arthritis Foundation. It comprised questions on sociodemographic and health characteristics, received PT (currently and/or in the past year) and, if applicable, its duration, frequency, and content (active exercises, manual treatment, physical modalities, and/or counselling/education)., Results: The study included 257 and 94 patients with self-reported diagnoses of RA and axSpA, of whom 163 (63%) and 77 (82%) currently or had recently received individual PT. The duration of individual PT was long-term (> 3 months) in 79% of RA and 83% of axSpA patients, with an average frequency of once per week in most. Although active exercises and counselling/education were each reported by ≥ 73% of the patients with RA and axSpA who received long-term individual PT, passive treatment modalities were also often offered (≥ 89%), in particular massage, kinesiotaping, and/or passive mobilization. The same pattern was seen in patients receiving short-term PT., Conclusion: The majority of patients with RA and axSpA received PT currently or in the past year, usually individually, long-term, and at a frequency of once a week. Although active exercises and education are recommended in guidelines, passive treatment options that are not advised were relatively often reported. An implementation study to identify barriers and facilitators regarding adherence to clinical practice guidelines seems warranted.

Objective: Assessing the construct validity of the Patient-Reported Outcomes Measurement Information System Physical Function 10-Item Short Form (PROMIS PF-10) in a subpopulation of rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) patients with severe limitations in physical functioning (PF)., Method: RA/axSpA patients with severe functional limitations completed the PROMIS PF-10, Health Assessment Questionnaire - Disability Index (HAQ-DI for RA) or Bath Ankylosing Spondylitis Functional Index (BASFI for axSpA), 36-item Short Form Health Survey (SF-36), EuroQol 5-dimensions 5-level (index score, EQ-VAS), and performed the Six-Minute Walk Test (6MWT). Construct validity was assessed by computing Spearman rank or Pearson correlation coefficients and testing hypotheses about correlations between the PROMIS PF-10 and measures of PF and quality of life., Results: Data from 316 patients (180 RA/136 axSpA, 91.7%/47.8% female, mean ± sd age 58.6 ± 13.2/54.0 ± 11.3 years) were analysed. The median (IQR) PROMIS PF-10 score was 34.5 (31.4-37.6) in RA and 36.0 (32.8-38.3) in axSpA patients. The PROMIS PF-10 correlated strongly with the HAQ-DI, BASFI, and EQ-5D-5L index score (r > 0.6), moderately with the SF-36 Physical Component Summary score, EQ-VAS, and 6MWT (0.30 ≤ r ≤ 0.60), and weakly with the SF-36 Mental Component Summary score (r < 0.30). Five of six hypotheses (83%) were confirmed in both groups., Conclusion: The overall strong correlation of the PROMIS PF-10 with measures of PF and moderate to weak correlations with outcomes measuring different constructs were confirmed in subpopulations of RA and axSpA patients with severe functional limitations, supporting its construct validity.

Objectives: To define the instruments for the Assessment of SpondyloArthritis international Society-Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA)., Methods: An international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments' psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS., Results: The updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments., Conclusions: The selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials., Competing Interests: Competing interests: VN-C: grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer and UCB. ABoonen: grants from AbbVie ad Novartis and honoraria for boards or lectures form Abbvie, Galapagos and Lilly. PJM: research grants, consultation fees and/or speaker honoraria from Abbvie, Aclaris, Amgen, Bristol Myers, Boehringer-Ingelheim, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Lilly, Novartis, Pfizer, SUN Pharma and UCB. MD: consulting fees Pfizer, AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma. UK: grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. RBML: honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli-Lilly, Novartis, Pfizer and UCB Pharma; Director of Rheumatology Consultancy BV. XB: consulting fees AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB. WB-M: research speaker's fees from Janssen, Lilly, Novartis, Pfizer and Biopas. PC: research grants/honoraria from Novartis, Pfizer, Zuellig Pharma and Janssen. LF: employee and shareholder of Pfizer. MG-C: research collaboration with and provides services to Novartis Pharma AG. LG: research grants/honoraria from AbbVie, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer and UCB. BKE: consultancy, research grants and speaker's fees from AbbVie, Amgen, BMS, Eva, Hekma, Janssen, Lilly, MSD, New Bridge, Novartis, Pfizer, Roche, Sanofi‐Aventis and Servier. NH: consultant for Amgen, Abbvie, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB. PMM: consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript. WM: consulting fees Abbvie, BMS, Boehringer, Celgene, Lilly, Janssen, Novartis, Pfizer and UCB; research and/or educational grants from Abbvie, Novartis and Pfizer; Chief Medical Officer CARE Arthritis Limited. AM: speaker honoraria for lectures, presentations from Abbvie, UCB, Novartis, Pfizer, Gilead, Janssen, MSD, BMS, Biogen and Lilly. NdP: employee of UCB Pharma. DP: research support from AbbVie, Lilly, MSD, Novartis and Pfizer, consulting fees from AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis and UCB and speaker fees from AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer and UCB. MP: speaker honoraria for lectures, presentations from Novartis and UCB. SR: research grants from Galapagos, MSD, Novartis and Pfizer and consulting fees from AbbVie, Eli Lilly, MSD, Novartis, UCB and Sanofi. I-HS: employee of AbbVie, Immunology Clinical Development, USA. DvdH: consulting fees AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology bv. ABoel, HD, YHK and SvW: no competing interests to declare., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Since decades, supervised group exercise (SGE) is recommended for people with axial spondyloarthritis (axSpA). This study examines if weekly SGE contributes to fulfillment of exercise recommendations in axSpA patients., Methods: Cross-sectional data from three studies with axSpA patients in The Netherlands, including two with outpatient populations (n = 196 and n = 153) and one with SGE participants (n = 128), were analysed. Sociodemographic and disease characteristics, SGE participation, health status (ASAS Health Index), spinal mobility and fulfillment of the recommendations for leisure-time aerobic (≥150 min/week moderate-intensity or ≥75 min/week vigorous-intensity) and strength and mobility (≥2 sessions/week) exercise (measured with SQUASH-questionnaire) were assessed. Differences between patients with and without SGE were analysed., Results: In the two outpatient populations (n = 349), 17 patients (5%) used SGE. The SGE participants (n = 145) were significantly older, had longer disease duration, were less frequently employed, used less medication and had worse spinal mobility than patients without SGE (n = 332). There were no significant differences in health status. Patients with SGE fulfilled the moderate-intensity aerobic (89 % vs. 69%) and strength and mobility (44 % vs. 29%) exercise recommendations more often than patients without SGE, but the aerobic exercise recommendation was less often fulfilled with vigorous-intensity exercise (5 % vs. 12%)., Conclusion: SGE is used by just few, especially older, axSpA patients and contributes to fulfilling recommendations for moderate-intensity, mobility and strength exercise. Both in patients with and without SGE, only a minority fulfilled the recommendations for vigorous-intensity, strength and mobility exercises. Therefore, future promotion of exercise should focus on implementing these types of exercise., (Copyright © 2022. Published by Elsevier Inc.)