5-year Results Research Articles

51569 Bimekizumab treatment resulted in sustained improvements in nail psoriasis and signs and symptoms of psoriatic arthritis in patients with baseline nail disease: 1-year pooled results from two phase 3 studies

51569 Bimekizumab treatment resulted in sustained improvements in nail psoriasis and signs and symptoms of psoriatic arthritis in patients with baseline nail disease: 1-year pooled results from two phase 3 studies

Arthroscopic repair of anteroinferior glenoid rim fractures: mean 10-year clinical and radiologic results

BackgroundTo date, long-term results of the arthroscopic repair of glenoid rim fractures are missing. The aim of this study was, to evaluate clinical and radiographic results following arthroscopic repair of anteroinferior glenoid fractures using anchors or bioabsorbable compression screws after a mean follow-up period of ten years. MethodsClinical outcome measures included evaluation of recurrent instability, the Constant Score (CS), Subjective Shoulder Value (SSV), Rowe Score (RS), Western Ontario Shoulder Instability Score (WOSI) and Melbourne Instability Shoulder Score (MISS). X-ray images were obtained for assessment of an instability arthropathy (IA). Results23 patients (7 female and 16 male, mean (± SD) age 48 ± 15 years) who underwent arthroscopic repair of an acute substantial solitary or multifragmented anteroinferior glenoid rim fracture were enrolled. After a mean follow-up period of 10 ± 2 years, patients reached a mean CS of 92 ± 10 points, SSV of 93 ± 11%, RS of 84 ± 20 points, WOSI of 98 ±2% and MISS of 91 ± 11 points. No patient suffered recurrent dislocation. Radiographic results were obtained of 18 patients. Signs of IA were noted in nine patients (50%) with progression of IA in all cases in comparison to the preoperative status. Patients with IA were significantly older (52 versus 38 years, p = 0.04). Clinical score results did not show a significant difference in patients with versus without IA except for the RS (74 versus 94 points, p = 0.02). No intra- or postoperative complications were observed, and no patient required revision endoprosthetic surgery. ConclusionArthroscopic repair of acute anteroinferior glenoid rim fractures shows good clinical long-term results. High rates of IA were observed especially in older patients. However, the presence of IA did not seem to influence the subjective shoulder score outcomes.

52842 Dupilumab Improves Health-Related Quality of Life and Work Productivity Among Adults With Moderate-to-Severe Atopic Dermatitis in Clinical Practice: 4-Year Follow-up Results From the RELIEVE-AD Study

52842 Dupilumab Improves Health-Related Quality of Life and Work Productivity Among Adults With Moderate-to-Severe Atopic Dermatitis in Clinical Practice: 4-Year Follow-up Results From the RELIEVE-AD Study

1095P Pembrolizumab versus placebo after a complete resection of high-risk stage III melanoma: 7-year results of the EORTC 1325-MG/Keynote-054 double-blind phase III trial

1095P Pembrolizumab versus placebo after a complete resection of high-risk stage III melanoma: 7-year results of the EORTC 1325-MG/Keynote-054 double-blind phase III trial

Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient

We report the 1-year results from one patient as the preliminary analysis of a first-in-human phase I clinical trial (ChiCTR2300072200) assessing the feasibility of autologous transplantation of chemically induced pluripotent stem-cell-derived islets (CiPSC islets) beneath the abdominal anterior rectus sheath for type 1 diabetes treatment. The patient achieved sustained insulin independence starting 75days post-transplantation. The patient's time-in-target glycemic range increased from a baseline value of 43.18% to 96.21% by month 4 post-transplantation, accompanied by a decrease in glycated hemoglobin, an indicator of long-term systemic glucose levels at a non-diabetic level. Thereafter, the patient presented a state of stable glycemic control, with time-in-target glycemic range at >98% and glycated hemoglobin at around 5%. At 1 year, the clinical data metall study endpoints with no indication of transplant-related abnormalities. Promising results from this patient suggest that further clinical studies assessing CiPSC-islet transplantation in type 1 diabetes are warranted.

First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

508MO Organ preservation in early rectal adenocarcinoma: 5-year results of the randomized opera trial

508MO Organ preservation in early rectal adenocarcinoma: 5-year results of the randomized opera trial

Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.

Psoriatic arthritis (PsA) is a chronic inflammatory disease requiring long-term treatment. Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated tolerability and sustained clinical efficacy for up to 1year for patients with PsA. Here, we report the longer-‍term safety and efficacy of bimekizumab up to 2years. BE OPTIMAL (biologic disease-modifying antirheumatic drug [bDMARD]-naïve) and BE COMPLETE (prior inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi-IR]) assessed subcutaneous bimekizumab 160mg every 4weeks in patients with PsA. BE OPTIMAL included a reference arm (adalimumab 40mg every 2weeks); patients switched to bimekizumab at week 52 with no washout between treatments. BE OPTIMAL week 52 and BE COMPLETE week 16 completers were eligible for the BE VITAL open-label extension. Efficacy outcomes are reported to week 104/100 (BE OPTIMAL/BE COMPLETE). A total of 710/852 (83.3%) bDMARD-naïve and 322/400 (80.5%) TNFi-IR patients completed week 104/100. Up to 104weeks, patients treated with bimekizumab in BE OPTIMAL and BE COMPLETE had treatment-emergent adverse event incidence rates (exposure-adjusted incidence rate/100 patient-years) of 179.9 (95% CI 166.9, 193.7) and 100.3 (89.2, ‍112.4), respectively. The proportion of patients achieving efficacy outcomes (≥ 50% improvement from baseline in American College of Rheumatology [ACR] response criteria, 100% improvement from baseline in Psorisis Area and Severity Index [PASI], minimal disease activity [MDA]) was sustained in all patients from week 52 to week 104/100. Bimekizumab was well tolerated for up to 2years of treatment and no new safety signals were observed. Sustained clinical efficacy was observed up to 2years in bDMARD-naïve and TNFi-IR patients with active PsA. Patients switching from adalimumab to bimekizumab demonstrated further improvement in skin and nail symptoms, and sustained efficacy in joint symptoms. BE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), BE VITAL (NCT04009499).

Preoperative Nutrition Impacts Retear Rate After Arthroscopic Rotator Cuff Repair.

A rotator cuff retear following arthroscopic rotator cuff repair (ARCR) is a concern in older patients. However, only a few of its risk factors are amenable to preoperative intervention. We aimed to elucidate the relationship between preoperative nutritional status and rotator cuff retears after ARCR. This single-center retrospective study included patients aged ≥65 years with rotator cuff tears who underwent ARCR. The Geriatric Nutritional Risk Index (GNRI) was used to assess preoperative nutritional status. Data collection encompassed patient demographics, clinical assessments, and surgical specifics. Patients were divided into healed and retear groups based on 2-year post-ARCR magnetic resonance imaging results. Logistic regression analysis was conducted to adjust for confounding factors and detect independent risk factors for retears. The GNRI cutoff value for retear prediction was determined by a stratum-specific likelihood ratio; clinical outcomes were compared based on the cutoff values obtained. Overall, 143 patients were included. The retear rate was 20.3%. The albumin level, GNRI, postoperative shoulder strength of abduction and external rotation, and postoperative Japanese Orthopaedic Association and Constant scores in the retear group were significantly lower than those in the healed group. The logistic regression analysis showed that low risk of morbidity and mortality (compared with no risk) based on the GNRI (odds ratio [OR], 3.39) and medial-lateral tear size per mm (OR = 1.10) were independent risk factors for a retear 2 years after ARCR. Stratum-specific likelihood ratio analysis identified data-driven strata as GNRI < 103, 103 ≤ GNRI < 109, and GNRI ≥ 109. Univariate analysis showed that patients with GNRI < 103 had a significantly higher retear risk than those with 103 ≤ GNRI < 109 and those with GNRI ≥ 109. Logistic regression analysis showed that GNRI < 103 compared with 103 ≤ GNRI < 109 (OR = 3.88) and GNRI < 103 compared with GNRI ≥ 109 (OR = 5.62), along with the medial-lateral tear size per mm (OR = 1.10), were independent risk factors for a retear at 2 years after ARCR. When assessing the risk of a retear after ARCR, GNRI ≥ 103 may indicate good preoperative nutritional status. However, more data are essential to ascertain the importance of this finding. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

4-Year Results With Ponatinib by Mutation Status in Patients With Chronic-Phase Chronic Myeloid Leukemia (CP-CML): OPTIC Study

4-Year Results With Ponatinib by Mutation Status in Patients With Chronic-Phase Chronic Myeloid Leukemia (CP-CML): OPTIC Study

CT-252 First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

CT-252 First 1-Year Results of a New Hematopoietic Stem Cell Transplant Center

CLL-431 4-Year Results With Ponatinib by Mutation Status in Patients With Chronic-Phase Chronic Myeloid Leukemia (CP-CML): OPTIC Study

CLL-431 4-Year Results With Ponatinib by Mutation Status in Patients With Chronic-Phase Chronic Myeloid Leukemia (CP-CML): OPTIC Study

Utilizing injury severity score, Glasgow coma scale, and revised trauma score for trauma-related in-hospital mortality and ICU admission prediction; originated from 7-year results of a nationwide multicenter registry

Objective: During the past few decades, many scoring systems have been developed to evaluate the severity of injury and predict the outcome in trauma patients. This study aimed to assess the capacity of three common trauma scoring systems: injury severity score (ISS), Glasgow coma scale (GCS), and revised trauma score (RTS) in predicting in-hospital mortality and ICU admission in patients with traumatic injury. Methods: This is a multicenter study of the hospital-based national trauma registry of Iran (NTRI), an ongoing registry-based trauma database. This study included trauma cases from 12 major trauma centers throughout the country admitted between July 2016 and November 2023. The inclusion criteria were all patients admitted to the emergency department due to trauma, hospitalized for at least 24 hours, deceased within the first 24 hours of admission, and patients transferred from the intensive care unit (ICU)s of other hospitals. Results: A total of 50,458 traumatic patients, with 38,740 (76.9%) being male, were included in this study. After adjustment for confounders, head, face, and neck injuries were associated with the highest odds of death (OR: 7.51, P-value&lt;0.001), whereas abdominal injuries were associated with the highest odds of ICU admission (OR: 4.58, P-value&lt;0.001). Each Unit increase in RTS score was accompanied by a 61% decrease in odds of death (OR: 0.39, P-value&lt;0.001). The area under the ROC curve for predicting in-hospital mortality was 0.81 (0.79 to 0.82) in ISS, 0.78 (0.77 to 0.80) in GCS, and 0.75 (0.73 to 0.76) in RTS. There was a significant difference between RTS and GCS, as well as RTS and ISS for in-hospital mortality prediction (P-values&lt; 0.001). The area under the ROC curve for the prediction of ICU admission was 0.75 (0.74 to 0.75) in ISS, 0.63 (0.62 to 0.63) in GCS, and 0.62 (0.61 to 0.63) in RTS. There was a statistically significant difference between ISS and GCS, as well as ISS and RTS, for ICU admission prediction (P-value&lt;0.001). Conclusion: ISS is the best predictor of in-hospital mortality and ICU admission, compared to GCS and RTS.

Fifteen-Year Results of a Comparative Analysis of Tendon Repair Versus Physiotherapy for Small-to-Medium-Sized Rotator Cuff Tears: A Concise Follow-up of Previous Reports.

The optimal treatment for small-to-medium-sized rotator cuff tears remains a topic of debate. While both tendon repair and physiotherapy have shown comparable short-term results, there are concerns about the long-term effectiveness of physiotherapy. In 2 previous reports presenting the 5 and 10-year results of this trial, significant and increasing differences were observed in favor of tendon repair. Further investigation of the unexplored time interval after 10 years is essential to fully understand the implications of our treatment approaches. A total of 103 patients with a full-thickness rotator cuff tear not exceeding 3 cm were randomly allocated to tendon repair or physiotherapy with optional secondary repair. Measurements of shoulder function were performed by a blinded assessor at 6 months and 1, 2, 5, 10, and 15 years. The outcome of primary interest was the 15-year result for the Constant score. Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons (ASES) score; the Short Form-36 (SF-36) Health Survey; assessments of pain, motion, and strength; and patient satisfaction. Tear-size increase in unrepaired tears was assessed by sonography. Statistical analysis was by mixed-model analysis for repeated measurements and by intention to treat. Eighty-three (81%) of 103 patients attended the 15-year follow-up. Fifteen of 51 patients in the physiotherapy group had crossed over to secondary surgery. Results from primary tendon repair were superior by a mean difference of 11.8 points for the Constant score (p = 0.001), 13.9 points for the ASES score (p < 0.001), 1.8 cm on a 10-cm visual analog scale for pain (p < 0.001), and 16.2° and 22.4°, respectively, for pain-free abduction and flexion (p = 0.04 and 0.001). On the SF-36, differences did not reach significance for any of the scoring scales. In 26 tears treated by physiotherapy only, the mean tear size had increased from 16.2 to 31.6 mm in the anterior-posterior direction. Long-term outcomes from primary tendon repair remained superior to physiotherapy up to 15 years of follow-up, supporting its use as the primary treatment for small-to-medium-sized rotator cuff tears. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Five-year Follow-up of a Prospective Food and Drug Administration Investigational Device Exemption Trial Evaluating a PEEK-on-Ceramic Cervical Disc Replacement.

Prospective trial comparing the investigation group to propensity matched historic control group. To evaluate 5-year results of single-level PEEK-on-ceramic cervical total disc replacement (TDR) compared to a propensity matched anterior cervical discectomy and fusion (ACDF) control group. Cervical TDR has gained acceptance as treatment for symptomatic disc degeneration. The design and materials used in these devices continue to evolve. Data were collected in the Food and Drug Administration Investigational Device Exemption trial for the PEEK-on-ceramic Simplify(®) Cervical Artificial Disc (n=150) with comparison to a propensity matched ACDF control group (n=117). All patients were treated for single-level cervical disc degeneration with radiculopathy and/or myelopathy. Clinical outcome was based on composite clinical success (CCS), Neck Disability Index (NDI), visual analog scales (VAS) assessing pain, re-operations, and satisfaction. Radiographic measures included segmental range of motion (ROM), disc space height, and heterotopic ossification (HO). Evaluations were performed pre-operatively and post-operatively within 2 and 6 weeks, and 3, 6, 12 months, and annually thereafter. At 5-year follow-up, CCS was significantly greater with TDR than ACDF (91.1% vs. 74.6%; P<0.01). In the TDR group, the mean NDI score was 63.3 pre-operatively, reduced significantly to 23.1 at 6 weeks and remained below 20 throughout 5-year follow-up. In the ACDF group, the mean pre-operative NDI score was 62.4, decreasing to 33.7 at 6 weeks, and ranged from 25.9 to 21.5 throughout follow-up. Mean NDI scores were significantly lower in TDR group at all post-operative points (P<0.05). Mean TDR ROM was 7.3o pre-operatively and 10.1o at 5 years. Bridging HO occurred in 9%. With TDR, there were 6 re-operations (4.0%) vs. 11 (9.4%) with ACDF (P>0.40). PEEK-on-ceramic TDR produced significantly improved outcomes maintained throughout 5-year follow-up, were similar or superior to ACDF, supporting TDR in appropriately selected patients.

Long-term Efficacy of Pulmonary Artery Desnervation Treatment in Heart Failure With Preserved Ejection Fraction: A Subgroup Analysis of 3-year Results From the PADN-5 Study

Objective: The Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure (PADN-5) study proved that pulmonary artery denervation (PADN) is associated with significant improvements in hemodynamic and clinical outcomes in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH). This study aimed to assess the 3-year clinical results of PADN in patients who had heart failure with preserved ejection fraction (HFpEF) developing into CpcPH (HFpEF-CpcPH). Methods: In this post hoc analysis of the PADN-5 trial, 38 patients with HFpEF were included in screening out of 98 patients with CpcPH who were randomly assigned to treatment with sildenafil and sham PADN (sham PADN (plus sildenafil) group, abbreviated as sham group) or PADN (PADN group). HFpEF in the PADN-5 trial was defined as a left ventricular ejection fraction ≥50%, and CpcPH was defined as a mean pulmonary arterial pressure ≥25 mmHg, a pulmonary arterial wedge pressure &gt;15 mmHg, and a pulmonary vascular resistance &gt;3.0 WU. The changes in the 6-minute walk distance (6-MWD) and the plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6-month and 3-year follow-up, as well as the clinical endpoint of the occurrence of clinical worsening, defined as cardiopulmonary-related death, rehospitalization, or heart or lung transplantation at 3-year follow-up were examined. Results: Thirty-eight patients with HFpEF-CpcPH were assigned to the PADN group (n = 19) or the sham group (n = 19). At the 6-month follow-up, 6-MWD (433 (275, 580)m vs. 342 (161, 552)m), and reductions in NT-proBNP (−47% (−99%, 331%) vs. −12% (−82%, 54%)) were significantly improved in the PADN group (all P &lt; 0.05). Over the 3-year follow-up period, PADN treatment resulted in marked increases in 6-MWD (450 (186, 510)m vs. 348 (135, 435)m) and reductions in NT-proBNP (−55% (−99%, 38%) vs. −10% (−80%, 95%)) (all P &lt; 0.05). Clinical worsening was experienced by 12 patients (63%) in the sham group, but by only 5 patients (26%) in the PADN group (hazard ratio = 0.149, 95% confidence interval: 0.038–0.584, P = 0.006). The 6-MWD and PADN treatments were independent predictors of clinical deterioration in patients with HFpEF-CpcPH. Conclusions: PADN therapy is associated with improvements in exercise capacity and clinical outcomes. PADN therapy may have a potential role in patients with HFpEF-CpcPH for whom current treatment options are limited.

Good 5-year results and a low redislocation rate using an á la carte treatment algorithm for patellofemoral instability in patients with severe trochlea dysplasia.

Trochlear dysplasia is a major risk factor for recurrent patellar instability, reduced quality of lifeand osteoarthritis of the patellofemoral joint. Patellar instability in patients with trochlear dysplasia can be treated by trochleoplasty, usually in combination with medial patellofemoral ligament reconstruction (MPFL-R). An á la carte treatment algorithm, which also addresses patella alta, lateralisation of the tibial tuberosityand valgus or torsional malalignment when present has been standard in one clinic for treatment of patellar instability patients since 2009, based on the hypothesis that it results in optimal subjective and clinical outcome, normalisation of the lateral trochlea inclination (LTI) angle and a low rate of patellar redislocation. This prospective study reports the 5-year results for consecutive patients with high-grade trochlea dysplasia operated according to the algorithm 2010-2017, evaluated preoperatively and 1, 2and 5 years postoperatively. Clinical information on previous surgery and postoperative patellar stability, range-of-motion (ROM)and subsequent surgery were registered. Subjective outcome was evaluated by four patient-reported outcome measures (PROMs): Kujala, Lysholm, International Knee Documentation Committee and Knee injury and Osteoarthritis Outcome Score. The LTI angle was measured pre- and postoperatively on magnetic resonance imaging scans. There were 131 patients (87 females) with a median age of 22 years (range: 14-38). All had a trochleoplasty and an MPFL-R. Additional procedures (tibial tuberosity medialisation/distalisation and/or femoral/tibial osteotomy) were performed in 52%. All PROM scores improved from preoperatively to 1-year follow-up with further improvement at 2 and 5 years after surgery (p < 0.05). Three patients (2%) had a traumatic patellar dislocation 9, 12and 24 months postoperativelyand 38% underwent subsequent surgery (hardware removal, arthroscopically assisted brisement force, knee arthroscopy). A normalisation of the LTI angle (≥11°) was achieved in 76%. Treatment according to the à la carte algorithm for patients with patellar instability and high-grade trochlear dysplasia resulted in significant clinical and subjective improvement in all PROM scores and a very low redislocation rate (2%) 5years after surgery. Level II.

Real-time regulation of detention ponds via feedback control: Balancing flood mitigation and water quality

Detention ponds can mitigate flooding and improve water quality by allowing the settlement of pollutants. Typically, they are operated with fully open orifices and weirs (i.e., passive control). Active controls can improve the performance of these systems: orifices can be retrofitted with controlled valves, and spillways can have controllable gates. The real-time optimal operation of its hydraulic devices can be achieved with techniques such as Model Predictive Control (MPC). A distributed quasi-2D hydrologic-hydrodynamic coupled with a reservoir flood routing model is developed and integrated with an MPC algorithm to estimate the operation of valves and movable gates in real-time. The control optimization problem is adapted to switch from a flood-related algorithm focusing on mitigating floods to a heuristic objective function that aims to increase the detention time when no inflow hydrographs are predicted. The case studies show the potential results of applying the methods developed in a catchment in Sao Paulo, Brazil. The performance of MPC compared to alternatives that do not change the operation over time with either fully or partially open valves and gates are tested. Comparisons with HEC-RAS 2D indicate volume and peak flow errors of approximately 1.4% and 0.91% for the watershed module. Simulating two consecutive 10-year storms shows that the MPC strategy can achieve peak flow reductions of 79%. In contrast, the passive scenario has nearly half of the performance (41%). A 1-year continuous simulation results show that the passive scenario with 25% of the valves opened can treat 12% more runoff compared to the developed MPC approach, with an average detention time of approximately 6 h. For the MPC approach, the average detention time is nearly 14 h, indicating that both control techniques can treat similar volumes; however, the proxy water quality for the MPC approach is enhanced due to the longer detention times achieved.

Comment on: Long-term risk prediction after major lower limb amputation: 1-year results of the PERCEIVE study

Comment on: Long-term risk prediction after major lower limb amputation: 1-year results of the PERCEIVE study

Effectiveness and Safety of Qishen Yiqi Dripping Pill in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention: 3-Year Results from a Multicentre Cohort Study.

To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill (QSYQ) in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). This multicentre prospective cohort study was conducted at 40 centers in China. Patients with ACS after PCI entered either the QSYQ or Western medicine (WM) groups naturally based on whether they had received QSYQ before enrollment. QSYQ group received QSYQ (0.52 g, 3 times a day for 12 months) in addition to WM. The primary endpoint included cardiac death, non-fatal myocardial infarction, and urgent revascularization. The secondary endpoint included rehospitalization due to ACS, heart failure, stroke, and other thrombotic events. Quality of life was assessed by the Seattle Angina Questionnaire (SAQ). A total of 936 patients completed follow-up of the primary endpoint from February 2012 to December 2018. Overall, 487 patients received QSYQ and WM. During a median follow-up of 566 days (inter quartile range, IQR, 517-602), the primary endpoint occurred in 46 (9.45%) and 65 (14.48%) patients in QSYQ and WM groups respectively [adjusted hazard ratio (HR) 0.60, 95% confidence interval (CI) 0.41-0.90; P=0.013]. The secondary endpoint occurred in 61 (12.53%) and 74 (16.48%) patients in QSYQ and WM groups, respectively (adjusted HR 0.76, 95% CI 0.53-1.09; P=0.136). In sensitivity analysis, the results still demonstrated that WM combined with QSYQ reduced the risk of the primary endpoint (HR 0.67, 95% CI 0.46-0.98; P=0.039). Moreover, QSYQ improved the disease perception domain of the SAQ (P<0.05). In patients with ACS after PCI, QSYQ combined with WM reduced the incidence of the primary endpoint. These findings provide a promising option for managing ACS after PCI and suggest the potential treatment for reducing the risk of primary endpoint included cardiac death, non-fatal myocardial infarction, and urgent revascularization through intermittent administration of QSYQ (Registration No. ChiCTR-OOC-14005552).