Long-term efficacy and safety of duloxetine in the management of painful chemotherapy induced peripheral neuropathy.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 236-236
Author(s):  
Sang Mi Ro ◽  
In Sook Woo
Keyword(s):  
Advanced Cancer ◽  
Systemic Chemotherapy ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Vinca Alkaloid ◽  
Disease Status ◽  
Chemotherapeutic Agents ◽  
Duration Of Treatment ◽  
Average Pain ◽  
Numerical Rating

236 Background: Accordingly, Quality of life in the survivorship of patients with cancer is becoming one of the important issues with a development of systemic anticancer treatment. About 40% of the patients who receive chemotherapeutic agents which have neuropathic potential suffer from painful CIPN. Various approaches to relieve the pain associated with CIPN have been attempted in clinical practice. Previously duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, has been reported to reduce painful CIPN when administered for 5 weeks. We retrospectively investigated the effect of duloxetine on the pain associated with CIPN over a prolonged period of administration. Methods: Between December 2014 and December 2016, patients with advanced cancer who complained of CIPN during or after systemic chemotherapy were eligible. Initially, 30 mg of duloxetine was administered daily for the first week and 60 mg daily was administered from the second week thereafter. The severity of pain was evaluated using a numerical rating scale from 0 to 10. Study follow-up was performed at regular visits according to the chemotherapy schedule or at the time of evaluation of disease status in the patients who completed systemic chemotherapy. However, the patients were allowed to visit whenever needed. Results: Twenty-seven patients were evaluable, the median age was 64 years (range, 23-83 years), and 11 patients were male and 16 patients were female. Twenty-four of the 27 patients received neurotoxic chemotherapeutic agents such as cisplatin, oxaliplatin, taxane and vinca alkaloid. Patients receiving duloxetine showed a significant reduction in the pain intensity from baseline and the mean decrease in the average pain score was 2.85 (95% CI 2.26-3.44, P < 0.001). Twenty-five (92.5%) of the 27 patients showed decreased pain after the use of duloxetine. Mean duration of treatment was 29 weeks (range, 1~130 weeks). Median duration of response was 19 weeks (range, 4~99 weeks). Treatment-related adverse events were nausea (17.2%), vomiting (3.4%) and dizziness (6.8%). Conclusions: Duloxetine demonstrated a durable efficacy and tolerability for painful CIPN in patients with advanced cancer.

scholarly journals Regression in the Symptoms and Discal Hernia in Case of Lumbar Radiculopathy

2020 ◽  
Vol 8 (B) ◽  
pp. 216-220
Author(s):  
M. A. Ivanova ◽  
V. A. Parfenov ◽  
Ekaterina Silina ◽  
A. I. Isaykin
Keyword(s):  
Rating Scale ◽  
Clinical Symptoms ◽  
Numerical Rating Scale ◽  
Intervertebral Disk ◽  
Lumbar Radiculopathy ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Numerical Rating ◽  
Reduction Of Pain ◽  
Magnetic Resonance Imaging Mri

BACKGROUND: Discogenic lumbar radiculopathy has a favorable potential for survival; the regression of clinical symptoms may outpace the subsidence of discal hernia. AIM: The objective of the study is comparing the clinical data and the results of magnetic resonance imaging (MRI) in patients with discogenic lumbar radiculopathy over 1 year of observation. MATERIALS AND METHODS: Thirty-two patients (13 males at the average age of 39.1 ± 11.8 years) with discogenic lumbar radiculopathy confirmed by MRI were examined in the study. The intensity of pain condition was assessed using the numerical rating scale; disability was assessed using the Oswestry disability index. Sixteen patients were subjected to repeated MRI. RESULTS: Statistically significant (p < 0.01) reduction of the average pain intensity and intensity of disability more than 2 times was observed as early as in the first 2 weeks. Gradual reduction of pain and disability was observed during the year. Reduction of discal hernia by more than 50% was observed on average after 8.7 ± 4.7 months. CONCLUSION: In the case of discogenic radiculopathy, the reduction of pain and related disability far outstrips the regression of the herniation of intervertebral disk.

scholarly journals Can Naloxegol Therapy Improve Quality of Life in Patients with Advanced Cancer?

Cancers ◽  
2021 ◽  
Vol 13 (22) ◽  
pp. 5736
Author(s):  
Rita Ostan ◽  
Giuseppe Gambino ◽  
Italo Malavasi ◽  
Gianluca Ronga ◽  
Maria Solipaca ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Bowel Function ◽  
Advanced Cancer Patients ◽  
Background Pain ◽  
Bowel Movements ◽  
Numerical Rating

This observational study aims to evaluate the efficacy of naloxegol therapy in resolving opioid-induced constipation (OIC) and in improving the quality of life in a home palliative care cancer setting. Advanced cancer patients with OIC (Rome IV criteria) not relieved by laxatives started a naloxegol therapy 25 mg/day for 4 weeks. Quality of life was evaluated by Patient Assessment of Constipation Quality-of-Life (PAC-QoL) at day 0 and day 28; background pain by Numerical Rating Scale, number of weekly spontaneous bowel movements and Bowel Function Index (BFI) were evaluated at day 0 and every week. Seventy-eight patients who completed the 4-week study improved all four PAC-QoL dimensions (physical and psychological discomfort, worries/concerns and satisfaction level). Weekly spontaneous bowel movements increased and BFI improved. Background pain reduced after seven days and remained lower during the following weeks. Seventy-two patients dropped out the study before day 28 with a reduced survival compared to patients completing the study. Even in these patients, an improvement of bowel function was observed after two weeks. Naloxegol was effective in improving the quality of life, resolving OIC and reducing overall pain in patients with advanced cancer.

Validation of the numerical rating scale versions of the Edmonton Symptom Assessment Aystem (ESAS) and ESAS-r among outpatients with advanced cancer.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e20638-e20638
Author(s):  
Breffni Hannon ◽  
Martin Dyck ◽  
Ashley Pope ◽  
Nadia Swami ◽  
Christopher Lo ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Symptom Assessment ◽  
Numerical Rating

Factors influencing the analgesic response over time of the oxycodone-naloxone association in painful cancer patients: GREAT study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10089-10089
Author(s):  
Oscar Corli ◽  
Lorenzo Legramandi ◽  
Mirko Marabese ◽  
Anna Roberto
Keyword(s):  
Pain Intensity ◽  
Cancer Patients ◽  
Rating Scale ◽  
Breakthrough Pain ◽  
Numerical Rating Scale ◽  
Analgesic Efficacy ◽  
Average Pain ◽  
Numerical Rating ◽  
Analgesic Response ◽  
Over Time

10089 Background: The prolonged use of opioids is usually associated with the appearance of adverse events as drowsiness, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting over time for the onset of tolerance while others, as constipation, persist. Clinical studies demonstrated that the association oxycodone-naloxone (OXN), reduced the constipation in the presence of unchanged analgesic efficacy. Though, the variability of the analgesic response to OXN is not explained yet. The aim of this study was to evaluate the association between the clinical and genetics factors and analgesics response at OXN. Methods: In this study the cancer patients with moderate to severe pain received OXN and followed for 28 days. At each visit pain intensity modifications of therapy and adverse drug reactions (ADRs) were recorded. The primary efficacy endpoint was the proportion of responders, defined as patients with a decrease of the average pain intensity from baseline to last visit ≥30% and a final average pain score≤4, measured on 0-10 numerical rating scale. Genetic tests to identify SNPs related to opioid response were performed in each patient. Results: 14 centers participated in the study and recruited 206 patients. Among 176 patients analyzed for a primary endpoint the mean age was 68 (SD 10); 56% were male. Average and worst pain intensity decreased from baseline to last visit from 6.2 to 2.9 and from 8.3 to 4.6 respectively. 81% of patients were responders. Digestive system tumors (p = 0.05), concomitant thyroid endocrinopathy (p = 0.023), psychological irritability (p = 0.0029) and breakthrough pain at baseline were found to decrease the risk of positive response. None of the investigated polymorphisms influenced the analgesic response. Moderate to severe intensity ADRs were mainly constipation (26%), drowsiness (19%) and dry mouth (12%). Conclusions: In patients with moderate to severe cancer pain, OXN showed a strong analgesic effect (about 50% pain reduction). In comparison with other studies the induced constipation appears substantially lower. Some clinical factors influence the analgesic response while none genetic polymorphisms modulate the response. Clinical trial information: NCT02293785.

scholarly journals La gestione del dolore procedurale nelle lesioni maligne fungiformi del distretto cervico-facciale/The management of procedural pain in the fungating malignant wounds of the cervical and facial area

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Antonino Lombardo ◽  
Francesco Stivala ◽  
Loredana Reina ◽  
Enrica Fontana ◽  
Rosalia Altini ◽  
...  
Keyword(s):  
Chronic Wounds ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Supportive Therapy ◽  
Psychosocial Problems ◽  
Physical Symptoms ◽  
Procedural Pain ◽  
Average Pain ◽  
Numerical Rating ◽  
Wound Pain

Le lesioni maligne fungiformi (LMF) sono lesioni croniche definite come un’infiltrazione della cute da parte del tumore o delle metastasi. Le lesioni possono presentarsi come noduli sollevati simili ad un cavolfiore (proliferativo), come un’ulcera crateriforme (distruttivo) o una combinazione di entrambe. Le LMF sono spesso associate a diversi segni, più comunemente cattivo odore, essudato, sanguinamento, dolore lesione-correlato, slought/necrosi, infezione e prurito. In più le lesioni interessanti il distretto cervico-facciale espongono il paziente a problemi psicologici e sociali. Perciò i pazienti con LMF richiedono cure palliative e una corretta gestione della lesione, non solo per il controllo dei sintomi fisici lesione correlati, ma anche per la risoluzione dei problemi psicosociali. È stato effettuato uno studio osservazionale presso la S.C. ORL U, Presidio Ospedaliero Molinette. Dal 1 gennaio 2016 al 31 maggio 2017 sono stati osservati un totale di 18 pazienti, di cui 12 uomini e 6 donne, affetti da LMF. Il dolore è stato valutato con una Scala di valutazione validata Numerical Rating Scale, con range da 0 a 10, dove zero corrisponde ad assenza di dolore e dieci al massimo del dolore immaginabile. L’obiettivo dello studio è stato quello di Valutare l’entità del dolore percepito dai pazienti durante il cambio della medicazione, includendo le fasi di: rimozione, detersione, debridment, cura della cute perilesionale, applicazione, chiusura e fissaggio. Rimozione: media dolore 2,3 DS±1. Detersione: media dolore 3,4 DS±2. Debridment: media dolore 3,4 DS±2. Confezionamento e Fissaggio: media dolore 5,3 DS±4. Alla luce dei risultati emersi, si evidenzia la necessità di un miglior controllo del dolore correlato alla medicazione. A tale scopo si è costituito un gruppo multidisciplinare. Il gruppo di lavoro ha elaborato appropriati schemi terapeutici differenziati in relazione al dolore basale e alla presenza o meno di terapia di supporto per la malattia oncologica di base. Gli schemi terapeutici elaborati verranno sperimentati sul campo al fine di valutarne l’efficacia sulla gestione del dolore procedurale. Fungating malignant wounds (FMW) are chronic wounds defined as a skin infiltration by the tumor or metastases. They may be present as raised nodules similar to a cauliflower (proliferative), as a crateriform ulcer (destructive) or a combination of both. The FMW are often associated with different signs, most commonly odor, exudate, bleeding, related wound pain, slough/necrosis, infection and pruritus. In addition the wounds of the cervico-facial district expose the patient to psychological and social problems. Therefore patients with FMW require palliative care and proper management of the wound, not only for the control of wound-related physical symptoms, but also for the resolution of psychosocial problems. From January 1, 2016 to May 31, 2017, a total of 18 patients were observed, including 12 men and 6 women with FMW. Pain was assessed with a validated Numerical Rating Scale, with a range from 0 to 10, where 0 corresponds to the absence of pain and 10 to the maximum of imaginable pain. To evaluate the amount of pain perceived by patients during dressing changes, including the steps of Removal, Cleansing, Debridment, Perilesional skin care, Dressing application, closure and fixation. Removal: average pain 2,3 DS±1. Cleansing: average pain 3,4 DS±2. Debridment: average pain 3,4 DS±2. Dressing Application and Fixation: average pain 5,3 DS±1. In the light of the results, there is a need for better dressing related pain control. For this purpose a multidisciplinary group was formed. The working group developed appropriate therapeutic patterns differentiated in relation to the pain before the intervention and the presence or absence of supportive therapy for the underlying oncological disease. These therapeutic schemes will be tested in practice in order to evaluate their effectiveness on the management of procedural pain.

Evaluation of the Appropriate Washout Period Following Fan Therapy for Dyspnea in Patients With Advanced Cancer: A Pilot Study

2017 ◽  
Vol 35 (2) ◽  
pp. 293-296 ◽  
Author(s):  
Jun Kako ◽  
Tatsuya Morita ◽  
Takuhiro Yamaguchi ◽  
Asuko Sekimoto ◽  
Masamitsu Kobayashi ◽  
...  
Keyword(s):  
Pilot Study ◽  
Surface Temperature ◽  
Advanced Cancer ◽  
Washout Period ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Rank Test ◽  
Face Surface ◽  
Numerical Rating ◽  
Signed Rank Test

Objectives: To clarify the duration required for dyspnea to return to baseline severity after fan therapy, to evaluate whether fan-to-legs therapy or no fan therapy would be a suitable control therapy, and to investigate changes in patients’ face surface temperature after fan therapy. Methods: In this pilot study, all participants received 3 interventions in the following order: no fan, fan to legs, and fan to face. Participants used a fan for 5 minutes, and they scored their dyspnea at 10-minute intervals for 60 minutes or until the score had returned to its baseline value, whichever occurred first. Nine patients with advanced cancer admitted to a palliative care unit were included; they had dyspnea at rest and rated its severity as at least 3 points on a 0- to 10-point numerical rating scale. Descriptive statistics and the Wilcoxon signed rank test were used to analyze the data. Results: All patients completed the study. Of the 9 participants, 6 experienced a clinical benefit from using a fan to their faces. Of these patients, only 2 participants’ (2 of 6) dyspnea scores returned to baseline by the end of the 60-minute assessment period after exposure to fan-to-face therapy. In fan-to-legs and no fan settings, there was no change in the dyspnea scores. There were significant differences between the baseline face surface temperature and that after fan-to-face and fan-to-legs settings. Conclusion: When using a crossover design to investigate the effect of fan therapy on dyspnea, 1 hour is an insufficient washout period.

scholarly journals Treatment of patients with acute and subacute dorsalgia

2018 ◽  
Vol 10 (3) ◽  
pp. 36-41 ◽  
Author(s):  
O. N. Gerasimova ◽  
V. A. Parfenov ◽  
E. Yu. Kalimeeva
Keyword(s):  
Physical Therapy ◽  
Pain Intensity ◽  
Manual Therapy ◽  
High Efficiency ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Visual Analogue Scale Pain ◽  
Duration Of Treatment ◽  
Numerical Rating ◽  
Personalized Approach

Objective: to investigate the efficiency of treatment for acute and subacute dorsalgia, by providing information to patients and by using nonsteroidal anti-inflammatory drugs (NSAIDs) without conducting physical therapy, reflexotherapy, and manual therapy. Patients and methods. A total of 140 patients (87 women and 53 men; mean age 50.7±17.6 years) with acute and subacute back pain were followed up. Out of them 127 (91%) patients were found to have nonspecific (musculoskeletal) pain; 13 (9%) had discogenic radiculopathy. All the patients were informed of the benign nature of the disease, the high probability of its rapid resolution, the feasibility of abandoning prolonged bedrest, and the lack of need for physical therapy, reflexotherapy, massage, and manual therapy. To reduce pain, the patients received meloxicam 15 mg/day orally or intramuscularly or first 15 mg/day intramuscularly and then orally. The investigators assessed pain intensity with the numerical rating scale and functional activity restrictions with the Roland-Morris disability (RMD) questionnaire. Results. After treatment, the visual analogue scale pain intensity scores decreased from an average of 6.4 to 1.0; the RMD scores dropped from 6.8 to 1.4 (p<0.001). The duration of treatment averaged 11.0±4.4 days. Comparison of different meloxicam dosage regimens showed no significant differences; a positive result was noted in all cases. No adverse events were observed during treatment. Conclusion. The investigation has shown the high efficiency of management in patients with acute and subacute dorsalgia, by providing information to patients (an education conversation), by using meloxicam, and by applying a personalized approach (treatment for concomitant diseases and conditions). Refusing physiotherapy, massage, acupuncture, and manual therapy substantially reduces the cost of treatment in patients with acute dorsalgia.

Comparing the efficacy of nebulized morphine with intravenous morphine in traumatic musculoskeletal pain management

2020 ◽  
Vol 8 (1) ◽  
pp. 21-21
Author(s):  
Mani Mofidi ◽  
Ali Dashti ◽  
Mahdi Rezai ◽  
Niloufar Ghodrati ◽  
Hoorolnesa Ameli ◽  
...  
Keyword(s):  
Pain Management ◽  
Pain Relief ◽  
Musculoskeletal Pain ◽  
Normal Saline ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Vital Signs ◽  
Categorical Variables ◽  
Intravenous Morphine ◽  
Numerical Rating

Introduction: This study was designed to compare the effectiveness of intravenous morphine with nebulized morphine in pain relief of patients referring to the emergency setting with traumatic musculoskeletal pain. Methods: This randomized, placebo-controlled and double-blind clinical study evaluated 160 patients 18 to 65 years of age with acute traumatic pain, who attended the emergency department during 2019. Subjects were assessed with Numerical Rating Scale based on inclusion and exclusion criteria and randomly divided into two groups. In one group, 80 patients received IV morphine (0.1 mg/kg+5 mL normal saline) plus an equivalent volume of IV placebo. In the second group, 80 patients received nebulized morphine (0.2 mg/kg+5 mL normal saline) plus nebulized placebo. Pain score was monitored in all patients with Numerical Rating Scale before and after intervention at baseline, 15, 30, 45, and 60-minute intervals. Patients’ vital signs and possible adverse events were evaluated in each observation time points. Finally, all participants were assessed for their satisfaction with pain management. Data were analyzed using repeated measure analysis for continuous variables and Binomial test for categorical variables Results: There was no significant difference between the demographic characteristics of patients in study groups. Pain relief between the two groups was similar during the observation (0, 15, 30, 45, 60 min) (P>0.05). There were no changes in vital signs between two groups, although the nebulized group had lower systolic blood pressure at the time-point of 15 minutes after the treatment initiation (P=0.03). Conclusion: Although Nebulized morphine has similar efficacy in comparison with IV route, nebulization might be considered as the clinically efficacious route of morphine administration with minimal side effects, providing optimal pain relief in patients.

Comparison of Analgesic Effect of Levobupivacaine with Dexmedetomidine and Levobupivacaine for Scalp Block before Supratentorial Craniotomy: A Randomized Controlled Trial

2020 ◽  
Vol 103 (10) ◽  
pp. 1028-1035
Keyword(s):  
Postoperative Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Control Group ◽  
Study Group ◽  
Analgesic Requirement ◽  
Supratentorial Craniotomy ◽  
Numerical Rating ◽  
Fentanyl Consumption ◽  
Scalp Block

Background: Craniotomy causes acute and chronic pain. Uncontrolled postoperative pain may lead to adverse events. Perioperative scalp nerves block is not only effective in reducing intraoperative hemodynamic response, but it also reduces postoperative pain and postoperative analgesia requirement. Objective: To compare the benefits of adding dexmedetomidine to levobupivacaine in scalp nerves block before craniotomy for the duration of analgesia in supratentorial craniotomy. Materials and Methods: After approval by the Committee for Research, 50 supratentorial craniotomy patients were randomized into two groups. The control group received 30 mL scalp nerves block with 0.25% levobupivacaine with adrenaline 1:200,000, whereas the study group received 30 mL scalp nerves block with 0.25% levobupivacaine with adrenaline 1:200,000 plus dexmedetomidine 1 mcg/kg. The primary outcome was the time to first analgesic requirement postoperatively. The secondary outcomes included intraoperative fentanyl consumption, verbal numerical rating scale, tramadol consumption, and complications during the first 24 hours postoperatively. Results: Patients in the study group had significantly increase time to the first analgesic requirement in postoperative period and reduced intraoperative fentanyl consumption. The median time to first analgesic requirement was 555 (360 to 1,035) minutes in the study group versus 405 (300 to 520) minutes in the control group (p=0.023). Intraoperative fentanyl consumption 125 (75 to 175) mcg in the study group was significantly lower than 200 (150 to 250) mcg in the control group (p=0.02). The verbal numerical rating scale at 1, 4, 8, 12 and 24 hours postoperatively, tramadol consumption, and complications during the first 24 hours postoperatively were not statistically significant different. Conclusion: Preoperative scalp nerves block with 0.25% levobupivacaine with adrenaline (1:200,000) with dexmedetomidine 1 mcg/kg significantly increased the time to first analgesic requirement and reduced intraoperative fentanyl consumption compared to 0.25% levobupivacaine with adrenaline (1:200,000) without perioperative complications. Keywords: Scalp block, Dexmedetomidine, Post-craniotomy analgesia, Supratentorial tumor, Levobupivacaine

scholarly journals P188 Secukinumab provides significant improvement of spinal pain and lowers disease activity in patients with axial spondyloarthritis: 24-week results from a randomised controlled Phase 3b trial

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Helena Marzo-Ortega ◽  
Chiara Perella ◽  
Denis Poddubnyy ◽  
Effie Pournara ◽  
Agnieszka Zielińska ◽  
...  
Keyword(s):  
Disease Activity ◽  
Primary Endpoint ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Spinal Pain ◽  
Stock Ownership ◽  
Double Blind ◽  
Low Disease Activity ◽  
Numerical Rating ◽  
Randomised Controlled

Abstract Background/Aims  SKIPPAIN (NCT03136861) is the first randomised controlled study involving a biological disease-modifying anti-rheumatic drug, with a primary endpoint of spinal pain at Week 8 in patients with axial spondyloarthritis (axSpA; ankylosing spondylitis [AS] and non-radiographic [nr]-axSpA). We present the 24-week results of secukinumab in reducing spinal pain and disease activity following step-up dosing. Methods  This double-blind, placebo-controlled Phase 3b study enrolled patients (aged ≥18 years) with active disease (BASDAI ≥4; average spinal pain numerical rating scale [NRS] score &gt;4 at baseline; inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs ≥4 weeks). Patients were randomised (3:1) to subcutaneous secukinumab 150 mg or placebo weekly followed by every 4 weeks (Q4W) from Week 4. At Week 8, placebo patients were re-randomised to secukinumab 150 or 300 mg Q4W. Patients originally randomised to secukinumab 150 mg were classified as responders or non-responders (spinal pain NRS score &lt;4 or ≥ 4, respectively) at Week 8. Responders were re-assigned to continue doubleblind secukinumab 150 mg Q4W (Arm A1). Non-responders were re-randomised to double-blind secukinumab 150 mg (Arm A2) or a step-up dose of 300 mg (Arm A3) Q4W. Treatment was up to Week 24. Primary endpoint: proportion of patients achieving an average spinal pain score &lt;4 on a 0-10 NRS with secukinumab vs placebo at Week 8. Results  380 axSpA patients (269/380 [70.8%] AS; 111/380 [29.2%] nr-axSpA) were randomised to secukinumab 150 mg (N = 285) or placebo (N = 95). The primary endpoint was met (proportion of spinal pain NRS [average] score responders: 32% vs 20%; odds ratio [95% confidence interval] 1.9 [1.1-3.3] favouring secukinumab vs placebo; P &lt; 0.05). Further reductions in spinal pain occurred at Week 24, especially in those initially randomised to placebo and switched to active drug. Pronounced improvements were observed in other disease activity measurements (Table 1). Numerically, more patients achieved ASDAS low disease activity at Week 24 post-secukinumab dose escalation (Arm A3) vs those remaining on the same dose (Arm A2). Conclusion  Secukinumab provided rapid, significant improvement in spinal pain and led to low disease activity in axSpA patients. Secukinumab dose escalation might be beneficial for patients not responding fully to the starting dose. P188 Table 1:Spinal pain and ASDAS-CRP scores at Weeks 8 and 24Week 8SEC 150 mg (N = 285)PBO (N = 95)Change from baseline in spinal pain NRS score (total), mean (SD) [n]-2.6 (2.5) [279]-1.5 (2.2) [92]Change from baseline in ASDAS-CRP score, mean (SD) [n]-1.2 (1.0) [271]-0.5 (0.8) [89]Week 24Active treatment group (SEC treatment starting at baseline)PBO switchers group (SEC treatment starting at Week 8)Arm A1 (SEC 150 R-150) N = 90Arm A2 (SEC 150 NR-150) N = 94Arm A3 (SEC 150 NR-300) N = 94Arm B1 (PBO-SEC 150) N = 45Arm B2 (PBO-SEC 300) N = 44Change from Week 8 in spinal pain NRS score (total), mean (SD) [n]-0.4 (1.5) [88]-2.1 (2.2) [93]-1.9 (2.2) [91]-2.5 (2.6) [45]-2.9 (2.6) [43]Change from baseline in ASDAS-CRP score, mean (SD) [n]-2.2 (1.0) [86]-1.2 (1.0) [93]-1.5 (1.0) [92]-1.5 (1.1) [44]-1.8 (0.9) [43]Arm A1=SEC responder to SEC 150 mg at Week 8 (SEC 150 R-150); Arm A2=SEC non-responder to SEC 150 mg at Week 8 (SEC 150 NR-150); Arm A3=SEC non-responder to SEC 300 mg at Week 8 (SEC 150 NR-300); Arm B1=Placebo patients to SEC 150 mg (PBO-SEC 150); Arm B2=Placebo patients to SEC 300 mg (PBO-SEC 300). ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using C-reactive protein; N, total number of patients randomised; n, number of evaluable patients; NR, non-responders; NRS, numerical rating scale; PBO, placebo; R, responders; SD, standard deviation; SEC, secukinumab. Disclosure  H. Marzo-Ortega: Consultancies; AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB. Grants/research support; Janssen, Novartis. C. Perella: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis Stock. D. Poddubnyy: Consultancies; Consultant/speaker for: AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, UCB. Grants/research support; AbbVie, MSD, Novartis, Pfizer. E. Pournara: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis Stock. A. Zielińska: Consultancies; Novartis, Pfizer. A. Baranauskaite: Consultancies; AbbVie. Member of speakers’ bureau; Novartis, AbbVie, Amgen, Roche, KRKA. S. Sadhu: Corporate appointments; Employee of Novartis. B. Schulz: Corporate appointments; Employee of Novartis. M. Rissler: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis Stock.

Sign in / Sign up

Export Citation Format

Share Document