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OBJECTIVE The aim of this study was to review the use of patient-controlled analgesia (PCA) in sickle cell disease (SCD) for pediatric patients with vaso-occlusive crisis (VOC) in our institution and to compare the effect of early vs late PCA start on pain relief and LOS. METHODS This retrospective study included all pediatric patients treated with PCA for a severe VOC from 2010 to 2016. “Early-PCA” was defined as start of PCA within 48 hours of arrival. Time to reach adequate analgesia was defined as the time to reach 2 consecutive pain scores less than 5/10 at 4-hour interval. RESULTS During the study period, 46 patients presented 87 episodes of VOC treated with PCA. Sixty-three patients with VOC were treated with Early-PCA and 24 with Late-PCA. Both groups were comparable except for median pain score at admission; the Early-PCA group had higher scores: 9.0/10 vs 7.0/10. Time to reach adequate analgesia could be evaluated only in a subset of patients (n = 32) but was shorter in the Early-PCA group with a median difference of 41.0 hours (95% CI −82.0 to −6.0). Early-PCA was associated with a median reduction in LOS of 3.4 days (95% CI −4.9 to −1.9). There was no difference between the 2 groups in terms of side effects and occurrence of acute chest syndrome during hospitalization. CONCLUSIONS In this study, a reduced time to reach adequate analgesia and LOS was noted in the Early-PCA group for severe VOC. A prospective study is required to confirm these results.

Umbilical cord blood transplantation (UCBT) has been used to treat malignant and non-malignant diseases. UCBT offers the advantages of easy procurement and acceptable partial HLA mismatches, but also shows delayed hematopoietic and immunological recoveries. We postulated that an intrabone (IB) infusion of cord blood could provide a faster short- and long-term engraftment in a pediatric population with malignant and non-malignant hematologic diseases. We conducted this phase I-II single arm, exploratory clinical trial (NCT01711788) from 2012 to 2016 in a single center. Fifteen patients aged from 1.9 to 16.4 years received an IB UCBT. Median time to neutrophils and platelet recoveries were 18 days (range: 13-36 days) and 42 days (range: 26-107 days), respectively. Rate of severe acute GVH grade was low, with only one patient with grade III aGVH. Relapse occurred in 5 patients (38.5%) and TRM occurred in 1 patient. This leads to 6 years EFS and OS of 66.7% and 80% respectively. In conclusion, IB UCBT is safe and well-tolerated in children and hematological recovery compared similarly to the results obtained with IV UCBT.

Introduction. Les soins des brûlures chez les enfants occasionnent beaucoup de douleur et d’appréhension. Le confort, un concept référant autant à l’absence de douleur physique qu’au bien-être, est important pour évaluer la qualité des soins prodigués par les infirmières aux jeunes enfants brûlés. À notre connaissance, aucun instrument n’existe actuellement pour mesurer le confort lors de procédures douloureuses chez les enfants ayant subi des brûlures. Objectif. Développer et valider une échelle de mesure du confort, lors de procédures douloureuses, chez les jeunes enfants ayant subi des brûlures. Méthodes. Une revue de la littérature a permis de générer 38 énoncés dont le nombre a été réduit à 14 par un panel composé de 13 professionnels de la santé. Les énoncés ont été ensuite regroupés sous quatre sous-échelles comportementales principales : visage, pleurs, mouvements et attitude. L’instrument développé (OCCEB-BECCO) a été ensuite pré-testé auprès de 16 enfants âgés de moins de 5 ans ayant subi des brûlures. Résultats. L’instrument était clair, concis et simple à utiliser selon les experts. L’alpha de Cronbach était de 0,82. La corrélation était élevée entre l’OCCEB-BECCO et l’échelle Face Legs Activity Cry Consolability (FLACC) (r≥0,95) à tous les temps de mesure. Discussion et conclusion. L’OCCEB-BECCO, première échelle visant à évaluer le confort d’enfants brûlés lors de procédures douloureuses, est une mesure fiable et valide. Cependant, d’autres études devront être effectuées, auprès de plus grands échantillons, pour compléter la validation de l’échelle., Introduction. Burn care causes children a great deal of pain and apprehension. Comfort, a concept referring as much to the absence of physical pain as to well-being, is a key consideration in assessing the quality of nursing care provided to young burn victims. However, no instrument existed to measure level of comfort of child burn victims during the delivery of painful care procedures. Objective. To develop and validate a scale to measure the comfort level of young child burn victims subjected to painful care procedures. Methods. Following a review of the literature, 38 items were generated to measure comfort in this context. These were reduced to 14 by a panel of 13 healthcare professionals. The items were then grouped under four main headings: face, cry, movement, and attitude. Finally, the new instrument (OCCEB-BECCO) was pre-tested on 16 burn victims under the age of 5. Results. Experts found the instrument to be clear, concise and easy to use. Cronbach’s alpha was 0.82. The correlation between the OCCEB-BECCO and the Face Legs Activity Cry Consolability (FLACC) scale was high (r≥0.95) at all times of measurement. Discussion and conclusion. The first scale of its kind, the OCCEB-BECCO is a reliable and valid measure of the comfort level of young child burn victims during painful procedures. However, more research is needed with larger samples to complete the scale’s validation.

Appropriate pain measurement relies on the use of valid, reliable tools. The aim of this study was to determine and compare the psychometric properties of 3 self-reported pain scales commonly used in the pediatric emergency department (ED). The inclusion criteria were children aged 6 to 17 years presenting to the ED with a musculoskeletal injury and self-reported pain scores ≥30 mm on the mechanical Visual Analogue Scale (VAS). Self-reported pain intensity was assessed using the mechanical VAS, Faces Pain Scale-Revised (FPS-R), and Colour Analogue Scale (CAS). Convergent validity was assessed by Pearson correlations and the Bland-Altman method; responsiveness to change was assessed using paired sample t tests and standardized mean responses; and reliability was estimated using relative and absolute indices. A total of 456 participants were included, with a mean age of 11.9 years ± 2.7 and a majority were boys (252/456, 55.3%). Correlations between each pair of scales were 0.78 (VAS/FPS-R), 0.92 (VAS/CAS), and 0.79 (CAS/FPS-R). Limits of agreement (95% confidence interval) were -3.77 to 2.33 (VAS/FPS-R), -1.74 to 1.75 (VAS/CAS), and -2.21 to 3.62 (CAS/FPS-R). Responsiveness to change was demonstrated by significant differences in mean pain scores among the scales (P < 0.0001). Intraclass correlation coefficient and coefficient of repeatability estimates suggested acceptable reliability for the 3 scales at, respectively, 0.79 and ±2.29 (VAS), 0.82 and ±2.07 (CAS), and 0.76 and ±2.82 (FPS-R). The scales demonstrated good psychometric properties for children with acute pain in the ED. The VAS and CAS showed a strong convergent validity, whereas FPS-R was not in agreement with the other scales.

To assess the feasibility, usefulness, and acceptability of using distraction kits, tailored to age, for procedural pain management of young children visiting the emergency department and requiring a needle-related procedure. A pre-experimental design was piloted. A kit, tailored to age (infants-toddlers: 3 months–2 years; preschoolers: 3-5 years), was provided to parents before their child's needle-related procedure. Data was collected to assess feasibility, usefulness, and acceptability of the kits by parents and nurses. Pain was measured pre-, peri-, and postprocedure using the Face, Legs, Activity, Cry, Consolability scale. A total of 25 infants and toddlers (mean age: 1.4 ± .7 years) and 25 preschoolers (mean age: 4.0 ± .9) participated in the study. Parents and nurses considered the kits useful and acceptable for distraction in the emergency department, especially in the postprocedural period. Addition of more animated and interactive toys to the kits was suggested. In the infants-toddlers group, mean pain scores were 1.6 ± 2.5 preprocedure, 7.1 ± 3.0 periprocedure, and 2.5 ± 2.5 postprocedure. In the preschoolers group, mean pain scores were 1.6 ± 3.0 preprocedure, 4.8 ± 3.4 periprocedure, and 2.0 ± 3.2 postprocedure. Distraction kits were deemed useful and acceptable by parents and emergency nurses. They are an interesting nonpharmacologic option for nurses to distract children, giving them a sense of control over their pain and improving their hospital experience. Future research should address the feasibility of distraction kits for a broader population of patients and a variety of painful procedures.

Background: Spinal fusion for scoliosis generates moderate to severe pain intensity. There are currently no instruments available to measure adolescents’ satisfaction regarding post-spinal fusion pain management. Aims: To develop and validate a scale on satisfaction of adolescents regarding pain management following spinal fusion for scoliosis. Methods: A methodological design was used to develop and validate the French-Canadian scale “Satisfaction des Adolescents de la gestion de la Douleur postopératoire – Scoliose idiopathique (SAD-S)”. A modified Delphi method, with seven healthcare professionals and 10 adolescents, was used to establish content validity of the SAD-S. A pre-test of the scale was conducted with 10 adolescents post-spinal fusion. The final version of the scale was validated through a pilot study with 98 adolescents following their surgery. Results: The SAD-S scale includes a total of 13 items. Principal component analysis yielded a two-factor structure (2 subscales): 1) Pain management education and 2) Education regarding medication. These two factors explained 47,8% of the total variance for satisfaction. A Cronbach’s alpha of 0,84 was obtained for internal consistency. Conclusion: Validation of the SAD-S scale showed that it has good psychometric properties with this population. Further validation is required with a larger sample to pursue its validation.

Objective To describe successful therapeutic strategies in statin-induced anti-HMGCR myopathy. Methods Retrospective data from a cohort of 55 patients with statin-induced anti-HMGCR myopathy, sequentially stratified by the presence of proximal weakness, early remission, and corticosteroid and IVIG use at treatment induction, were analyzed for optimal successful induction and maintenance of remission strategies. Results A total of 14 patients achieved remission with a corticosteroid-free induction strategy (25%). In 41 patients treated with corticosteroids, only 4 patients (10%) failed an initial triple steroid/IVIG/steroid-sparing immunosuppressant (SSI) induction strategy. Delay in treatment initiation was independently associated with lower odds of successful maintenance with immunosuppressant monotherapy (OR 0.92, 95% CI 0.85 to 0.97, P = 0.015). While 22 patients (40%) presented with normal strength, only 9 had normal strength at initiation of treatment. Conclusion While corticosteroid-free treatment of anti-HMGCR myopathy is now a safe option in selected cases, initial triple steroid/IVIG/SSI was very efficacious in induction. Delays in treatment initiation and, as a corollary, delays in achieving remission decrease the odds of achieving successful maintenance with an SSI alone. Avoiding such delays, most notably in patients with normal strength, may reset the natural history of anti-HMGCR myopathy from a refractory entity to a treatable disease.

Background: Anemia is a common feature of RA. Prior to the appearance of biologic treatments, improvement of hemoglobin (Hb) levels was unusual and inconsistent. With better control of the inflammatory process with cytokine inhibitors, it has been shown that Hb levels can improve substantially. Recently in the development of IL-6 receptor antagonists (sarilumab (SARI) and tocilizumab (TOCI)) data have shown improvement in Hb levels related to the down-regulation of hepcidin. No direct comparison of Hb levels between TNF and IL-6 inhibition has been explored in observational data (1). Objectives: This analysis compares the impact of TNF and IL-6 inhibitors on Hb levels over time. Methods: Data collected since January 1, 2015 (when TOCI and SARI were available in Canada) at the Institut de Recherche en Rhumatologie de Montreal (IRRM) and the Centre de l’Osteoporose et de Rhumatologie de Quebec (CORQ) was extracted from the Rhumadata® clinical database and registry on January 7, 2019. Selected patients were those initiated on an IL-6 antagonist or a TNFi (adalimumab, certolizumab, etanercept, golimumab or infliximab) and had been treated for at least one year. Furthermore, patients were cancer free and had no diagnosis of Crohn’s disease or ulcerative colitis and had creatinine (Cr) and ALT levels within the normal sex-specific range. IL-6 patients were matched (ratio 1:2) to TNFi patients based on age at treatment initiation, gender and baseline Hb. The collected data include baseline characteristics (socio-demographic variables, concomitant and past medication, comorbidities and the Charlson comorbidity index (CCI)), variables measured over time (Hb and other laboratory test results, patient and physician-reported outcomes, and disease activity measures such as CDAI and DAS28(4)-ESR. The groups were compared to identify potential confounder. Results: A total of 145 patients initiating an IL-6 antagonist since January 1, 2015 were matched with 286 patients prescribed a TNF inhibitor during the same time-period. Most patients were women (86%), the mean age at treatment initiation was 54.1 (standard deviation=11.7) years, and 16% were smokers. Baseline patient global, pain and fatigue assessments, made on a visual analogue scale ranging from 1 to 10, were 5.4 (2.5), 6.1 (2.5) and 5.5 (3.0) in the IL6 group and 5.1 (2.7), 5.5 (3.0) and 5.0 (3.2) in the TNFi group. Baseline disease activity was assessed as moderate or high/severe in 85.5% (IL6) and 85.9% (TNFi) of patients (DAS28(4)-ESR criteria). At treatment initiation, mean Hb level was 126.6 (12.4) g/L, and Cr and ALT levels were 66.2 (11.5) umol/L and 18.7 (6.5) U/L in the IL6 group and 67.0 (12.0) umol/L and 19.3 (6.8) U/L in the TNFi group. At three months, Hb had increased by 5.4 (10.2) g/L in the IL6 group and by 1.8 (13.9) g/L in the TNFi group (p-value=0.024). These respective changes at 12 months were 8.7 (11.4) g/L and 5.4 (9.2) g/L (p-value=0.042). Conclusion: This analysis confirms that IL-6 inhibition provides a numerically and statistically superior increase in Hb over TNFi. Reference: [1] Song, et al. Arthritis Research & Therapy 2013, 15:R141 Disclosure of Interests: Denis Choquette Grant/research support from: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant for: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer Inc, Loic Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant for: AbbVie, Amgen, Novartis, Pfizer, Speakers bureau: Amgen, Pfizer, Paul Haraoui Grant/research support from: Abbvie, Amgen, Pfizer, UCB, Consultant for: Abbvie, Amgen, Lilly, Pfizer, Sandoz, UCB, Speakers bureau: Pfizer, Frederic Massicotte Consultant for: AbbVie, Pfizer, Janssen, Eli Lilly, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: Shareholder in ArthroLab Inc., Grant/research support from: Study funded by TRB Chemedica SA, Consultant for: TRB Chemedica SA, Jean-Pierre Raynauld Consultant for: ArthroLab Inc., Marie-Anais Remillard Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Edith Villeneuve Consultant for: AbbVie, UCB, Celgene, Roche, Pfizer, Amgen, BMS, Sanofi-Genzyme, Paid instructor for: AbbVie, Speakers bureau: AbbVie, Pfizer, BMS, Roche, Louis Coupal: None declared

Background Tofacitinib (TOFA), a targeted synthetic DMARD, has been approved for the treatment of rheumatoid arthritis (RA) in Canada since April 2014. This oral agent preferentially inhibits signalling by cytokine receptors associated with JAK1 and JAK3 subunits. It is also indicated for the treatment of PsA and UC since October 2018. Clinical experience with this molecule has been increasing, and questions relating to its efficacy and long-term safety are of interest. Data collection through RHUMADATA®, a Quebec based clinical database and registry, allows comparison of newer options with more traditional agents such as tumor necrosis factor inhibitors (TNFi). Objectives The current analysis compares TOFA to TNFi used with and without methotrexate (MTX) among patients with RA. Methods Data collected since January 1, 2014 (when TOFA became available in Canada) at the Institut de Recherche en Rhumatologie de Montreal (IRRM) and the Centre de l’Osteoporose et de Rhumatologie de Quebec (CORQ) was extracted from Rhumadata® on January 7, 2019. Patients initiated on TOFA or a TNFi (adalimumab, certolizumab, etanercept, golimumab, infliximab) without or with MTX were selected. Data include baseline characteristics (socio-demographic variables, concomitant and past medication, comorbidities and the Charlson comorbidity index (CCI)), variables measured over time (lab results, patient and physician-reported outcomes, and disease activity measures) and persistence data (treatment duration, reason for cessation). The groups were compared to identify potential confounder, and persistence data were analyzed using Kaplan-Meier and Cox methods. Results A total of 480 patients were prescribed TOFA (n=162) or a TNFi (n=318) since January 1, 2014. Of those, 57% (n=92) and 70% (n=224) were treated with MTX in the TOFA and TNFi group respectively and mean disease duration was 12.1 (standard deviation=11.0) and 7.2 (8.1) years. TOFA and TNFi represent the first treatment following csDMARD-IR for 33%(TOFA) and 62%(TNFi). In the TOFA group, 84% were women, 15% were smokers and the mean age at treatment initiation was 57.7 (11.5) years. In the TNFi group, 77% were women, 12% were smokers and the mean age at treatment initiation was 54.2 (13.7) years. At treatment initiation, patient global, pain and fatigue assessments, made on a visual analogue scale ranging from 1 to 10, were 5.6 (2.5), 5.9 (2.7) and 5.7 (2.9) in the TOFA group and 5.0 (2.9), 5.5 (3.0) and 5.1 (3.1) in the TNFi group. Baseline disease activity was assessed as moderate or high/severe in 85.9% and 76.7% of TOFA (?) patients (DAS28(4)-ESR criteria). Among the 56 (35%) TOFA and 146 (46%) TNFi patients ceasing therapy, reasons for cessation were “inefficacy” (TOFA: 64% vs TNFi: 56%) and “adverse events” (TOFA: 16% vs TNFi: 11%). Patients remaining on TOFA and TNFi therapy at last follow-up had an average treatment duration of 1.7 (1.1) and 2.7 (1.5) years and no difference in retention was observed between TOFA and TNFi treated patients (log-rank p=0.41). Patients treated with a TNFi in combination with MTX had better treatment retention than those treated without MTX (log-rank p=0.04) while patients treated with TOFA+/-MTX had similar retention (log-rank p=0.96). These results remain unchanged when adjusted for gender, age at treatment initiation, disease duration, and comorbidities. Conclusion In our real-world data registry, treatment with TNFi and TOFA yielded similar retention over time. Subjects treated with TNFi and MTX remained on treatment longer than those treated without MTX while subjects treated with tofacitinib with or without MTX had similar retention. Disclosure of Interests Denis Choquette Grant/research support from: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant for: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer Inc, Loic Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant for: AbbVie, Amgen, Novartis, Pfizer, Speakers bureau: Amgen, Pfizer, Paul Haraoui Grant/research support from: Abbvie, Amgen, Pfizer, UCB, Consultant for: Abbvie, Amgen, Lilly, Pfizer, Sandoz, UCB, Speakers bureau: Pfizer, Frederic Massicotte Consultant for: AbbVie, Pfizer, Janssen, Eli Lilly, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: Shareholder in ArthroLab Inc., Grant/research support from: Study funded by TRB Chemedica SA, Consultant for: TRB Chemedica SA, Jean-Pierre Raynauld Consultant for: ArthroLab Inc., Marie-Anais Remillard Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Edith Villeneuve Consultant for: AbbVie, UCB, Celgene, Roche, Pfizer, Amgen, BMS, Sanofi-Genzyme, Paid instructor for: AbbVie, Speakers bureau: AbbVie, Pfizer, BMS, Roche, Louis Coupal: None declared

Background Tofacitinib (TOFA), a targeted synthetic DMARD, has been approved for the treatment of rheumatoid arthritis (RA) in Canada since April 2014. This oral agent preferentially inhibits signalling by cytokine receptors associated with JAK1 and JAK3 subunits. It is now indicated for the treatment of psoriatic arthritis (PsA) and ulcerative colitis (UC) since October 2018. Clinical experience with this molecule has been increasing, and questions relating to its efficacy and long-term safety are of interest. Data collection through RHUMADATA®, a Quebec based clinical database and registry, allows comparison of various advanced treatment options including TOFA and non-TNFi biologic agents (i.e., agents with other modes of action - OMA) such as fusion proteins (abatacept), and IL-6 (sarilumab, tocilizumab) and CD20 inhibitors (rituximab). Objectives This analysis compares TOFA and OMAs used with and without methotrexate (MTX). Methods Data collected since January 1, 2014 (since TOFA became available in Canada) at the Institut de Recherche en Rhumatologie de Montreal (IRRM) and the Centre de l’Osteoporose et de Rhumatologie de Quebec (CORQ) was extracted from the Rhumadata® on January 7, 2019. The selected patients had initiated therapy with either TOFA or OMA (either without or in combination with MTX). The collected data include baseline characteristics (socio-demographic variables, concomitant and past medication, comorbidities and the Charlson comorbidity index (CCI)), variables measured over time (laboratory test results, patient and physician-reported outcomes, and disease activity measures such as CDAI and DAS28(4)-ESR) and persistence data (treatment duration, reason for cessation). The groups were compared to identify potential confounder, and persistence data were analyzed using Kaplan-Meier and proportional hazard methods. Results A total of 483 patients were initiated on TOFA (n=162) or an OMA (n=321) since January 1, 2014. Of those, 57% (n=92) and 59% (n=191) were treated with MTX in the TOFA and OMA group respectively. These represent the first treatment following csDMARD inadequate response for 33%(TOFA) and 29%(OMA) of these patients. These patients had a mean disease duration of 12.1 (standard deviation=11.0) and 11.1 (10.3) years. In the TOFA group, 84% were women, 15% were smokers, and the mean age at treatment initiation was 57.7 (11.5). In the OMA group, 75% were women, 18% were smokers, and the mean age at treatment initiation was 57.3 (12.0) years. Patient global, pain and fatigue assessments, made on a visual analogue scale ranging from 1 to 10, were 5.6 (2.5), 5.9 (2.7) and 5.7 (2.9) in the TOFA group and 5.7 (2.5), 6.1 (2.7) and 6.0 (2.8) in the OMA group. Disease activity was assessed as moderate or high/severe in 85.9% and 88.3% of patients (DAS28(4)-ESR criteria). Among the 56 (35%) TOFA and 149 (46%) OMA patients ceasing therapy, reasons for cessation were “inefficacy” (TOFA: 64% vs OMA: 59%) and “adverse events” (TOFA: 16% vs TNFi: 17%). Patients remaining on TOFA and OMA therapy at last follow-up had an average treatment duration of 1.7 (1.1) and 2.6 (1.4) years. No difference in retention was observed between TOFA and OMA treated patients (log-rank p=0.6138). Patients treated with an OMA+/-MTX had similar retention (log-rank p=0.2640) as did patients treated with TOFA+/-MTX (log-rank p=0.9553). These results remain unchanged when we adjust for age at treatment initiation, gender, disease duration, and comorbidities (CCI) using Cox models. Conclusion OMA and TOFA have similar retention as do subjects treated with OMA or TOFA with or without MTX. Disclosure of Interests Denis Choquette Grant/research support from: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant for: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer Inc, Loic Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant for: AbbVie, Amgen, Novartis, Pfizer, Speakers bureau: Amgen, Pfizer, Paul Haraoui Grant/research support from: Abbvie, Amgen, Pfizer, UCB, Consultant for: Abbvie, Amgen, Lilly, Pfizer, Sandoz, UCB, Speakers bureau: Pfizer, Frederic Massicotte Consultant for: AbbVie, Pfizer, Janssen, Eli Lilly, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: Shareholder in ArthroLab Inc., Grant/research support from: Study funded by TRB Chemedica SA, Consultant for: TRB Chemedica SA, Jean-Pierre Raynauld Consultant for: ArthroLab Inc., Marie-Anais Remillard Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Edith Villeneuve Consultant for: AbbVie, UCB, Celgene, Roche, Pfizer, Amgen, BMS, Sanofi-Genzyme, Paid instructor for: AbbVie, Speakers bureau: AbbVie, Pfizer, BMS, Roche, Louis Coupal: None declared

Background Secukinumab (SECU) is a human IgG1κ monoclonal antibody that binds to the protein interleukin-17A approved for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis (PsA). Recently presented data suggest that combination with methotrexate (MTX) in patients with PsA may not be as necessary as in rheumatoid arthritis as it improves neither efficacity nor sustainability (1,2,3,4). Objectives This analysis describes the use of SECU with or without MTX. Methods The data of patients with psoriatic arthritis seen since January 1, 2015 (date at which SECU appeared in the Canadian market) at the Institut de Recherche en Rhumatologie de Montreal (IRRM) and the Centre de l’Osteoporose et de Rhumatologie de Quebec (CORQ) was extracted from the Rhumadata® clinical database and registry on January 7, 2019. Selected patients initiated SECU either without (MTX-) or with MTX (MTX+). The collected data include baseline characteristics (socio-demographic variables, concomitant and past medication, comorbidities and the Charlson comorbidity index (CCI)), variables measured over time (laboratory test results, patient and physician-reported outcomes, and disease activity measures such as minimal disease activity (MDA), CDAI and DAS28(4)-ESR) and persistence data (treatment duration, reason for cessation). The groups were compared to identify potential confounder, and persistence data were analyzed using Kaplan-Meier and proportional hazard methods. Results A total of 96 patients were prescribed SECU since January 1, 2015. Of those, 49% (n=47) treated with MTX. No significant differences in baseline (at treatment initiation) were observed between the MTX+ and MTX- groups. Average age at treatment initiation was 52.4 (standard deviation=11.3) and 53.7 (13.4) in the MTX+ and MTX- groups respectively. Women represent 45% and 55% of these groups, and the average body mass index was 29.9 (6.2) and 28.1 (6.0) kg/m2. Patient global, pain and fatigue assessments, made on a visual analogue scale ranging from 1 to 10, were 4.9 (2.6), 5.3 (2.9) and 4.3 (2.9) in the MTX+ group and 6.3 (2.2), 6.9 (2.1) and 6.5 (2.9) in the MTX- group. Among the 38 (40%) patients ceasing therapy, the principal reason for cessation was “inefficacy” (MTX+: 15/17 (88%) vs MTX-: 15/21 (71%)). Patients remaining on treatment at last follow-up had an average treatment duration of 1.7 (0.8) and 1.5 (0.7) years. The improvement in CDAI, HAQ and the percentage of patients reaching MDA are similar for both groups. No difference in retention was observed between the MTX+ and MTX- groups (log-rank p=0.4867). These results remain unchanged when we adjust for age at treatment initiation, gender, disease duration, and comorbidities (Charlson comorbidity index). Conclusion Combining MTX to SECU does not improve its sustainability over time. Efficacy was also the same for both cohorts. References [1] Mease PJ, et al. Arthritis Rheumatol. 2018; 70 (suppl 10). Abstract L11 [2] Benryane O, et al. Arthritis Rheumatol. 2018; 70 (suppl 10). Abstracts 693 and 694 [3] Benryane O, et al. CRA-2019, Montreal, Canada. Disclosure of interests Denis Choquette Grant/research support from: abbvie, amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Consultant for: abbvie, amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: abbvie, amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Louis Bessette Grant/research support from: abbVie, amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer inc, Roche, Sanofi, UCB, Consultant for: abbVie, Celgene, Eli Lilly, Novartis, Pfizer inc, Loic Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant for: abbVie, amgen, Novartis, Pfizer, Speakers bureau: amgen, Pfizer, Paul Haraoui Grant/research support from: abbvie, amgen, Pfizer, UCB, Consultant for: abbvie, amgen, Lilly, Pfizer, Sandoz, UCB, Speakers bureau: Pfizer, Frederic Massicotte Consultant for: abbVie, Pfizer, Janssen, Eli Lilly, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: Shareholder in arthroLab inc., Grant/research support from: Study funded by TRB Chemedica SA, Consultant for: TRB Chemedica SA, Jean-Pierre Raynauld Consultant for: arthroLab inc., Marie-Anais Remillard Consultant for: abbvie, amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: abbvie, amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: abbvie, amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Edith Villeneuve Consultant for: abbVie, UCB, Celgene, Roche, Pfizer, amgen, BMS, Sanofi-Genzyme, Paid instructor for: abbVie, Speakers bureau: abbVie, Pfizer, BMS, Roche, Louis Coupal: None declared

Background:Since the introduction of biologic agents around the turn of the century, the scientific evidence shows that the majority of agents, independent of the therapeutic target, have a better outcome when used in combination with methotrexate (MTX). In 2014, tofacitinib (TOFA), an agent targeting Janus kinase 1 and 3, has reached the Canadian market with data showing that the combination with MTX may not be necessary [1,2].Objectives:To evaluate the efficacy and retention rate of TOFA in real-world patients with rheumatoid arthritis (RA).Methods:Two cohorts of patients prescribed TOFA was created. The first cohort was formed of patients who were receiving MTX concomitantly with TOFA (COMBO) and the other of patients using TOFA in monotherapy (MONO). MONO patients either never use MTX or were prescribed MTX post-TOFA initiation for at most 20% of the time they were on TOFA. COMBO patients received MTX at the time of TOFA initiation or were prescribed MTX post-TOFA initiation for at least 80% of the time. For all those patients, baseline demographic data definitions. Disease activity score and HAQ-DI were compared from the initiation of TOFA to the last visit. Time to medication discontinuation was extracted, and survival was estimated using Kaplan-Meier calculation for MONO and COMBO cohorts.Results:Overall, 194 patients were selected. Most were women (83%) on average younger than the men (men: 62.6 ± 11.0 years vs. women: 56.9 ± 12.1 years, p-value=0.0130). The patient’s assessments of global disease activity, pain and fatigue were respectively 5.0 ± 2.7, 5.2 ± 2.9, 5.1 ± 3.1 in the COMBO group and 6.2 ± 2.5, 6.5 ± 2.6, 6.3 ± 2.8 in the MONO group all differences being significant across groups. HAQ-DI at treatment initiation was 1.3 ± 0.7 and 1.5 ± 0.7 in the COMBO and MONO groups, respectively, p-value=0.0858. Similarly, the SDAI score at treatment initiation was 23.9 ± 9.4 and 25.2 ± 11.5, p-value=0.5546. Average changes in SDAI were -13.4 ± 15.5 (COMBO) and -8.9 ± 13.5 (MONO), p-value=0.1515, and changes in HAQ -0.21 ± 0.63 and -0.26 ± 0.74, p-value 0.6112. At treatment initiation, DAS28(4)ESR were 4.4 ± 1.4 (COMBO) and 4.6 ± 1.3 (MONO), p-value 0.5815, with respective average changes of -1.06 ± 2.07 and -0.70 ± 1.96, p-value=0.2852. The Kaplan-Meier analysis demonstrated that the COMBO and MONO retention curves were not statistically different (log-rank p-value=0.9318).Conclusion:Sustainability of TOFA in MONO or COMBO are not statistically different as are the changes in DAS28(4)ESR and SDAI. Despite this result, some patients may still benefit from combination with MTX.References:[1]Product Monograph - XELJANZ ® (tofacitinib) tablets for oral administration Initial U.S. Approval: 2012.[2] Reed GW, Gerber RA, Shan Y, et al. Real-World Comparative Effectiveness of Tofacitinib and Tumor Necrosis Factor Inhibitors as Monotherapy and Combination Therapy for Treatment of Rheumatoid Arthritis [published online ahead of print, 2019 Nov 9].Rheumatol Ther. 2019;6(4):573–586. doi:10.1007/s40744-019-00177-4.Disclosure of Interests:Denis Choquette Grant/research support from: Rhumadata is supported by grants from Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Consultant of: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Speakers bureau: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Loïc Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant of: Pfizer, Abbvie, Amgen, Novartis, Speakers bureau: Pfizer, Amgen, Boulos Haraoui Grant/research support from: Abbvie, Amgen, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, and UCB, Consultant of: Abbvie, Amgen, Lilly, Pfizer, Sandoz, UCB, Consultant of: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Merck, Pfizer, Roche, and UCB, Speakers bureau: Pfizer, Speakers bureau: Amgen, BMS, Janssen, Pfizer, and UCB, Frédéric Massicotte Consultant of: Abbvie, Janssen, Lilly, Pfizer, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: ArthroLab Inc., Grant/research support from: TRB Chemedica, Speakers bureau: TRB Chemedica and Mylan, Jean-Pierre Raynauld Consultant of: ArthroLab Inc., Marie-Anaïs Rémillard Consultant of: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Édith Villeneuve Consultant of: Abbvie, Amgen, BMS, Celgene, Pfizer, Roche, Sanofi-Genzyme,UCB, Paid instructor for: Abbvie, Speakers bureau: AbbVie, BMS, Pfizer, Roche, Louis Coupal: None declared

Summary Background Fast-track recovery processes are implemented for pediatric day case surgery. We conducted a prospective study to evaluate postoperative comfort and parental satisfaction of children included in this process to improve quality of care. Methods We included all children scheduled for superficial procedures or dental treatment outside the operating room. A questionnaire was explained to parents before hospital discharge to evaluate the first night at home. Postoperative comfort evaluation included postoperative pain score (FLACC scale), incidence of postoperative nausea and vomiting, and postoperative behavior disorders. Incidence of posthospital behavior disturbance was evaluated measuring postoperative agitation at home, and disinterest with toys and games. Parental satisfaction was evaluated with a four-point Likert scale (1 = not satisfied at all, 2 = not satisfied, 3 = satisfied, 4 = very satisfied). Results One hundred and forty-three questionnaires were returned to hospital. Despite reduced length of stay in short-stay unit after anesthesia (28 ± 34 min), we did not report serious complications, and global parental satisfaction was good about the care process. Pain scores (FLACC >3) were higher in the group scheduled for dental procedures, but were very low for the other superficial surgery. With an odd ratio of 5.8 (95% confidence interval 2–17; P = 0.001), postoperative behavior modification (agitation or disinterest with toys or games) was the strongest variable that can predict parental dissatisfaction. Conclusion Optimal pain management, better parental information about risks of postoperative behavior disturbances, and program integrating parent and child preparation should improve quality of care and global satisfaction in the fast-track recovery process.

BACKGROUND: Musculoskeletal injuries (MSK-Is) are a common and painful condition among children that remains poorly treated in the emergency department (ED). We aimed to test the efficacy of a combination of an anti-inflammatory drug with an opioid for pain management of MSK-I in children presenting to the ED. METHODS: In this randomized, double-blinded, placebo-controlled trial, we enrolled children between 6 and 17 years presenting to the ED with an MSK-I and a pain score >29 mm on the visual analog scale (VAS). Participants were randomly assigned to oral morphine (0.2 mg/kg) + ibuprofen (10 mg/kg) (morphine + ibuprofen) or morphine (0.2 mg/kg) + placebo of ibuprofen or ibuprofen (10 mg/kg) + placebo of morphine. Primary outcome was children with VAS pain score RESULTS: A total of 501 participants were enrolled and 456 were included in primary analyses (morphine + ibuprofen = 177; morphine = 188; ibuprofen = 91). Only 29.9% (morphine + ibuprofen), 29.3% (morphine), and 33.0% (ibuprofen) of participants achieved the primary outcome (P = .81). Mean VAS pain reduction at 60 minutes were −18.7 (95% confidence interval [CI]: −21.9 to −16.6) (morphine + ibuprofen), −17.0 (95% CI: −20.0 to −13.9) (morphine), −18.6 (95% CI: −22.9 to −14.2) (ibuprofen) (P = .69). Children in the morphine + ibuprofen group (P < .001) and in the morphine group (P < .001) experienced more side effects than those in the ibuprofen group. No serious adverse event was reported. CONCLUSIONS: Combination of morphine with ibuprofen did not provide adequate pain relief for children with MSK-I in the ED. None of the study medication provided an optimal pain management because most of children did not reach a mild pain score (NCT02064894).

Christelle Khadra,1–3 Sylvie Le May,1,2 Ariane Ballard,1,2 Jean Théroux,1,4 Sylvie Charette,5 Edith Villeneuve,6,7 Stefan Parent,2,8,9 Argerie Tsimicalis,10,11 Jill MacLaren Chorney12,13 1Faculty of Nursing, Université de Montréal, 2CHU Sainte-Justine Research Centre, 3Montreal Chest Institute, McGill University Health Centre, Montreal, QC, Canada; 4School of Health Professions, Murdoch University, Perth, WA, Australia; 5Direction of Nursing, 6Department of Anesthesia, CHU Sainte-Justine, 7Department of Anesthesia, 8Department of Surgery, Faculty of Medicine, Université de Montréal, 9Orthopaedic Service, Department of Surgery, CHU Sainte-Justine, 10Ingram School of Nursing, McGill University, 11Shriners Hospitals for Children, Montreal, QC, 12Pediatric Complex Pain Team, IWK Health Centre, 13Department of Anesthesia, Pain Management, and Perioperative Medicine, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada Background: Spinal fusion is a common orthopedic surgery in children and adolescents and is associated with high pain levels postoperatively. If the pain is not well managed, negative outcomes may ensue. To our knowledge, there is no measure in English that assesses patient’s satisfaction with postoperative pain management following idiopathic scoliosis surgery. The aim of the present study was to assess the psychometric properties of the satisfaction subscale of the English version of the Satisfaction of Adolescents with Postoperative pain management– idiopathic Scoliosis (SAP-S) scale.Methods: Eighty-two participants aged 10–18years, who had undergone spinal fusion surgery, fully completed the SAP-S scale at 10–14days postdischarge. Construct validity was assessed through a principal component analysis using varimax rotation.Results: Principal component analysis indicated a three-factor structure of the 13-item satisfaction subscale of the SAP-S scale. Factors referred to satisfaction regarding current medication received (Factor 1), actions taken by nurses and doctors to manage pain (Factor 2) and information received after surgery (Factor 3). Cronbach’s alpha was 0.91, showing very good internal consistency. Data on satisfaction and clinical outcomes were also reported.Conclusion: The SAP-S is a valid and reliable measure of satisfaction with postoperative pain management that can be used in both research and clinical settings to improve pain management practices. Although it was developed and validated with adolescents who had undergone spinal fusion surgery, it can be used, with further validation, to assess adolescents’ satisfaction with pain management in other postoperative contexts. Keywords: satisfaction, pain management, adolescents, scoliosis, orthopedics, postoperative pain

OBJECTIVES: To determine the change in established biomarkers of cardiovascular (CV) risk, namely, total cholesterol/high-density lipoprotein cholesterol ratio (TC/HDL-C), N-terminal pro-brain natriuretic peptide (NT-proBNP) and insulin resistance (IR) in patients with early RA treated with two different treat-to-target strategies.METHODS: Fasting glucose, lipids, insulin and NT-proBNP were measured at baseline, weeks 26 and 78 in 79 DMARD-naïve RA patients, free of CV disease, as part of a double-blind randomized controlled trial of MTX with either infliximab (IFX) or methylprednisolone as induction therapy. Homeostasis model assessment-estimated IR (HOMA-IR) (glucose*insulin/405) was used to measure IR. Multiple imputation was employed, and linear regression analyses were adjusted for baseline values.RESULTS: Changes in DAS44-CRP did not differ between the treatment arms at weeks 26 and 78. Mean TC/HDL-C, HOMA-IR and NT-proBNP improved in both groups at weeks 26 and 78, although change in NT-proBNP was not statistically significant at week 78. Changes in TC/HDL-C and NT-proBNP were similar between treatment arms, but HOMA-IR values in the IFX + MTX arm were 42% lower than those treated with MTX + methylprednisolone at week 78 (P = 0.003); the difference remained significant after adjustment for baseline BMI, ACPA positivity, smoking status and intramuscular glucocorticoid use (P = 0.007).CONCLUSION: When implementing a treat-to-target approach, treatment of early RA was associated with improvement in TC/HDL-C, HOMA-IR and NT-proBNP, and a greater long-term improvement in HOMA-IR was seen in those treated with IFX.TRIAL REGISTRATION: EU Clinical Trials Register, http://www.clinicaltrialsregister.eu, Eudract-2005-005013-37; ISRTCNregisrty, http://www.isrctn.com, ISRCTN48638981.

BACKGROUND Vaso-occlusive crisis (VOC) is one of the most distressing occurrences in patients with sickle cell disease (SCD). Patient controlled analgesia (PCA) is recommended by NIH and expert opinions favor its early use. OBJECTIVES We aim to review the use of PCA in patients with VOC and to evaluate if its early use is associated with faster pain control and reduced length of stay (LOS). DESIGN/METHODS This retrospective single center study included all paediatric patients admitted and treated with PCA for a severe VOC from 2010 to 2016. “Early” use was defined as start of PCA within 48 hours of arrival in the emergency department (ED) and “late” use after 48 hours. Time to reach adequate analgesia was defined as OUCHER, verbal scale or Faces Pain Scale < 5/10 obtained twice consecutively in a 4-hours interval. Time to reach adequate analgesia and LOS were compared between early-PCA and late-PCA groups. RESULTS A total of 46 patients presented 87 episodes of VOC treated with PCA during the study. Sixty-one episodes (70%) were treated with early-PCA and 26 (30%) with late-PCA. Both groups were comparable in terms of age (13.2 vs 12.8 years old), gender (55.8% female vs 57.7%), hemoglobin phenotype (80.3% HbSS vs 76.9%), but median pain score at admission was higher in early-PCA than in late-PCA (9/10 vs 7/10, median difference 1 (95% CI 0, 2). Early-PCA was associated with a median reduction in LOS of 3.15 days (95% CI 1.65, 4.82) (median early-PCA LOS 6.4 vs late-PCA 10.0 days). Time to reach analgesia could be evaluated only in a subset of patients (20 in early-PCA and 12 in late-PCA group). Although time to reach adequate analgesia tended to be shorter in the early-PCA group, it was not statistically different: median102.9 hours vs 123.5 hours, difference of 30.4 (95% CI -4.0,72.5). Side effects were observed during 29 (33.3%) PCA treatments (19/61 (31.2%) episodes in early-PCA, 10/26 (38.5%) in late-PCA group) among which 16 (18.6%) were significant adverse events. These were observed in 15 patients who required interventions: 2 desaturations requiring oxygen without intubation, 8 neurologic abnormalities (hallucinations, visual abnormalities, no stroke), 6 urinary retentions. CONCLUSION Early use of PCA for severe VOC was associated with a reduced length of hospital stay despite that these patients had higher pain score on admission. Prospective studies are needed to support these positive outcomes.

There is accumulating evidence demonstrating that early treatment leads to better outcomes in rheumatoid arthritis. In order to be treated early, patients thus need to be identified at the earliest possible stage. This means identifying patients with rheumatoid arthritis at their earliest clinical signs but it could also mean screening for healthy individuals at high risk of developing rheumatoid arthritis. The different tools available to screen for these individuals are reviewed here and their relevance is discussed.

Objective. To systematically review the differential diagnosis and minimal clinical investigation used prior to making a diagnosis of undifferentiated peripheral inflammatory arthritis (UPIA). Methods. A systematic literature search was performed for articles published between January 1950 and December 2008 in Medline and Embase, and for abstracts presented at the 2007 and 2008 meetings of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR). Studies including defined cohorts of patients with UPIA were retrieved according to predefined inclusion/exclusion criteria. Selected studies were systematically reviewed and relevant data extracted. Baseline characteristics were also recorded to obtain a clinical picture of patients classified as UPIA. Results. Seventy-four articles were included. Of those, 52 reported baseline characteristics. Tremendous variation existed among studies, reflecting the different inclusion/exclusion criteria used. Rheumatoid arthritis, spondyloarthropathies, osteoarthritis, crystal arthritis, connective tissue diseases, and infections were the most common diagnoses of exclusion for UPIA and made up the other subsets of patients in cohorts with mixed populations. The baseline investigation undertaken prior to diagnosis of UPIA was reported in 7 articles. History, physical examination, tender and swollen joint count, rheumatoid factor, HLA-B27, erythrocyte sedimentation rate, C-reactive protein, and radiographs of hands and feet were the only items mentioned in at least 50% of the reports. Conclusion. Studies of UPIA are heterogeneous. Few studies reported on the minimal clinical investigation necessary to arrive at a diagnosis of UPIA. Differential diagnosis usually consisted of the most common rheumatologic conditions but could be vast.

Objective. To review the diagnostic and prognostic value of history/physical examination among patients with undifferentiated peripheral inflammatory arthritis (UPIA). Methods. We conducted a systematic review evaluating the association between history/physical examination features and a diagnostic or prognostic outcome. Results. Nineteen publications were included. Advanced age, female sex, and morning stiffness were predictive of a diagnosis of rheumatoid arthritis (RA) from UPIA. A higher number of tender and swollen joints, small/large joint involvement in the upper/lower extremities, and symmetrical involvement were associated with progression to RA. Similar features were associated with persistent disease and erosions, while disability at baseline and extraarticular features were predictive of future disability. Conclusion. History/physical examination features are heterogeneously reported. Several features predict progression from UPIA to RA or a poor prognosis. Continued measurements in the UPIA population are needed to determine if these features are valid and reliable predictors of outcomes, especially as new definitions for RA and disease states emerge.

The management of rheumatoid arthritis has greatly improved in the past decade, owing to new treatment strategies and the introduction of agents that inhibit tumor necrosis factor (TNF). Unfortunately, a substantial proportion of patients will discontinue therapy with their first TNF inhibitor for various reasons (for example, non-response, loss of efficacy, or toxicity). Until recently, treatment options for these patients were limited and most rheumatologists chose to switch to treatment with an alternative TNF inhibitor. However, biologic agents with different modes of action have now become available. Hence, the dilemma now facing rheumatologists presented with patients who fail to respond to anti-TNF therapy is whether to switch to an alternative TNF inhibitor or to change to a biologic agent of a different drug class. This article discusses the evidence relating to these two options.

In recent years, patient outcomes have improved dramatically with the availability of effective treatments for the management of rheumatoid arthritis (RA). RA, however, is a heterogeneous disease with variable disease progression and treatment response. Whereas some patients respond to a single disease-modifying antirheumatic drug, others require more intensive treatment strategies. Assessing disease severity at diagnosis and monitoring disease activity on an individual level would be a more accurate way of tailoring therapy, ensuring optimal treatment for those at greatest risk of disease progression, long-term disability, and joint damage without unnecessary overtreatment. Assessment of disease activity and severity is currently based on a combination of clinical and laboratory parameters that aid treatment decisions. Use of biomarkers may provide a more accurate means of objectively assessing the disease. This article reviews the role of biomarkers in the management of RA.

Evaluation of: van der Helm-van Mil AH, Detert J, le Cessie S et al.: Validation of a prediction rule for disease outcome in patients with recent-onset undifferentiated arthritis, moving toward individualized treatment decision-making. Arthritis Rheum. 58(8), 2241–2247 (2008). The decision to start disease-modifying antirheumatic drugs in patients with undifferentiated arthritis (UA) is not always easy, as the natural disease progression is variable. Van der Helm-van Mil and colleagues have recently developed a prediction rule to estimate the chance of progression to rheumatoid arthritis in individual patients presenting with early UA. In this study, the prediction score was calculated and validated in three independent cohorts of patients with UA, and has been shown to have a good discriminative ability for assessing the likelihood of progression to rheumatoid arthritis in approximately 75% of individual patients with recent-onset UA.

BACKGROUND: Acute liver failure is a rare condition in which massive liver injury is associated with the rapid development of hepatic encephalopathy. Although viral hepatitis and drug-induced liver injury are the most common causes, no specific etiology is found in a substantial proportion of cases reported from Europe and the United States.AIM: To determine the etiology and outcome of patients with acute liver failure in the authors’ institution.PATIENTS AND METHODS: The charts of 81 consecutive patients admitted to Saint-Luc between 1991 and 1999 were reviewed.RESULTS: The etiology was viral in 27 cases (33.2%), toxic or drug-induced in 22 (27.2%), of unknown origin in 22 (27.2%) and due to various causes in 10 (12.3%) (autoimmune, vascular, cancer). Of the 81 patients, 16% survived without liver transplantation, and 84% died or underwent liver transplantation. Survival without liver transplantation differed according to the mode of presentation: the survival rate was 27% in patients with hyperacute liver failure, 7% in those with acute liver failure and 0% in those with subacute liver failure. Among the 38 patients who underwent liver transplantation, survival one year after transplantation was 71%. In the 30 patients who died without liver transplantation, the main causes of death were cerebral edema and sepsis.CONCLUSIONS: Acute liver failure is associated with a high mortality, and liver transplantation is the treatment of choice. In a significant proportion of cases, the etiology remains undetermined and is probably related to yet unidentified hepatotropic viruses.

To compare the efficacy of etanercept (ETN) and methotrexate (MTX) versus MTX monotherapy for remission induction in patients with early inflammatory arthritis.In a 78-week multicentre randomised placebo-controlled superiority trial, 110 DMARD-naïve patients with early clinical synovitis (≥1 tender and swollen joint, and within 3 months of diagnosis) and either rheumatoid factor, anticitrullinated protein antibodies or shared epitope positive were randomised 1:1 to receive MTX+ETN or MTX+placebo (PBO) for 52 weeks. Injections (ETN or PBO) were stopped in all patients at week 52. In those with no tender or swollen joints (NTSJ) for26 weeks, injections were stopped early. If patients had NTSJ12 weeks after stopping the injections, MTX was weaned. The primary endpoint was NTSJ at week 52.No statistically significant difference was seen for the primary endpoint (NTSJ at week 52 (32.5% vs 28.1% [adjusted OR 1.32 (0.56 to 3.09), p=0.522]) in the MTX+ETN and MTX+PBO groups, respectively). The secondary endpoints did not differ between groups at week 52 or 78. Exploratory analyses showed a higher proportions of patients with DAS28-CRP2.6 in the MTX+ETN group at week 2 (38.5% vs 9.2%, adjusted OR 8.87 (2.53 to 31.17), p=0.001) and week 12 (65.1% vs 43.8%, adjusted OR 2.49 (1.12 to 5.54), p=0.026).In this group of patients with early inflammatory arthritis, almost a third had no tender, swollen joints after 1 year. MTX+ETN was not superior to MTX monotherapy in achieving this outcome. Clinical responses, however, including DAS28-CRP2.6, were achieved earlier with MTX+ETN combination therapy.The EMPIRE trial is registered on the following trial registries: Eudract-2005-005467-29; ISRCTN 55428162 (http://www.controlled-trials.com/ISRCTN55428162/EMPIRE). The full trial protocol can be obtained from the corresponding author.

In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction.In a 78-week multicentre randomised controlled trial, double-blinded to week 26, 112 treatment-naive RA patients (1987 American College of Rheumatology classification criteria) with disease activity score 44 (DAS44)2.4 were randomised to MTX + IFX or MTX + single dose intravenous methylprednisolone 250 mg. A treat-to-target approach was used with treatment escalation if DAS442.4. In the IFX group, IFX was discontinued for sustained remission (DAS441.6 for 6 months). The primary outcome was change in modified total Sharp-van der Heijde score (mTSS) at week 50.The mean changes in mTSS score at week 50 in the IFX and intravenous steroid groups were 1.20 units and 2.81 units, respectively (adjusted difference (95% CI) -1.45 (-3.35 to 0.45); p=0.132). Radiographic non-progression (mTSS2.0) occurred in 81% vs 71% (OR 1.77 (0.56 to 5.61); p=0.328). DAS44 remission was achieved at week 50 in 49% and 36% (OR 2.13 (0.91 to 5.00); p=0.082), and at week 78 in 48% and 50% (OR 1.12 (0.47 to 2.68); p=0.792). Exploratory analyses suggested higher DAS28 remission at week 6 and less ultrasound synovitis at week 50 in the IFX group. Of the IFX group, 25% (14/55) achieved sustained remission and stopped IFX. No substantive differences in adverse events were seen.In DMARD-naive early RA patients, initial therapy with MTX+high-dose intravenous steroid resulted in good disease control with little structural damage. MTX+IFX was not statistically superior to MTX+intravenous steroid when combined with a treat-to-target approach.

Orthopedic surgery for adolescent idiopathic scoliosis entails anxiety and severe postoperative pain. The aim of this pilot study was to investigate an intervention for adolescent post-spinal fusion pain management in patients from a tertiary care hospital in Montreal, Canada. Participants were adolescents and young adults ages 11 to 20 years undergoing spinal fusion. Participants were randomized to standard care or standard care with adjunct intervention. The intervention consisted of a DVD with information and guided imagery/relaxation exercises to practice at least three times a week at home. A nurse screened the DVD with the patient preoperatively and at discharge (T1) and telephoned 2 weeks post-discharge (T2) to reinforce the technique. Both groups completed questionnaires at T1, T2, and T3 (1-month postoperative follow-up). Outcome measures included pain intensity, anxiety, coping mechanisms, and daily activities. From March 2010 to June 2011, we enrolled 40 of 45 eligible participants (n = 20 per group), average age 15 ± 2.1 years, 7 participants were male. Compared with the control group, the experimental group experienced significantly less overall pain at all time points, with moderate to large effect sizes at T2, T3 (p ≤ .007). Worst pain in 24 hours was moderately decreased at T2 (p = .01). State-trait anxiety remained high. On a 10-point scale, a median 2.5-point benefit was seen in eating and sleeping (Mann-Whitney test, p = .002), and 2 points in walking (Mann-Whitney test, p = .003). Coping strategies showed no significant differences. Addition of a guided imagery and relaxation exercise DVD for home use was more effective than standard care alone for postoperative pain. Our nonpharmacologic adjunct looks promising. Larger sample size and longer (6-9 months) follow-up will permit refinement.

Background Despite the importance of timely management of patients with inflammatory arthritis (IA), delays exist in its diagnosis and treatment. Objective To perform a systematic literature review to identify strategies addressing these delays to inform an American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) taskforce. Methods The authors searched literature published between January 1985 and November 2010, and ACR and EULAR abstracts between 2007–2010. Additional information was obtained through a grey literature search, a survey conducted through ACR and EULAR, and a hand search of the literature. Results (1) From symptom onset to primary care, community case-finding strategies, including the use of a questionnaire and autoantibody testing, have been designed to identify patients with early IA. Several websites provided information on IA but were of varying quality and insufficient to aid early referral. (2) At a primary care level, education programmes and patient self-administered questionnaires identified patients with potential IA for referral to rheumatology. Many guidelines emphasised the need for early referral with one providing specific referral criteria. (3) Once referred, early arthritis clinics provided a point of early access for rheumatology assessment. Triage systems, including triage clinics, helped prioritise clinic appointments for patients with IA. Use of referral forms standardised information required, further optimising the triage process. Wait times for patients with acute IA were also reduced with development of rapid access systems. Conclusions This review identified three main areas of delay to care for patients with IA and potential solutions for each. A co-ordinated effort will be required by the rheumatology and primary care community to address these effectively.

Aims To determine the effect of a nurse telephone follow-up on paediatric post-tonsillectomy pain intensity, complications, and use of other healthcare services. Background After tonsillectomy, children experience moderate-to-severe pain for days. Parents tend to give insufficient analgesia, with resulting increases in pain and postoperative complications. In adults, nurse telephone follow-up for ambulatory surgeries reduces postoperative pain. Design The study design was a randomized clinical trial. Methods In this trial, children aged 4–12 years undergoing elective tonsillectomy in June–October 2010 were assigned to a nurse telephone follow-up with parents on postoperative days 1, 3, 5 and 10, or standard care with no follow-up but data collection. Outcomes included pain intensity, analgesics administered, complications, and healthcare use. Results Of 45 participants, the intervention group (n = 24) received more analgesics on postoperative days 1 and 3, increased their fluid intake at days 1 and 3, but had more constipation at day 3 than the control group (n = 21). There was no significant difference regarding pain intensity or use of healthcare resources. Conclusion Nurse telephone follow-up was beneficial for some pain management and prevention of complications, although better analgesic treatments are needed. The intervention was simple, safe, and appreciated by parents.

Umbilical cord blood transplantation (UCBT) has been used to treat malignant and non-malignant diseases. UCBT offers the advantages of easy procurement, immediate availability, and acceptable partial HLA mismatches. Still, patients treated with UCBT show delayed hematopoietic and immunological recoveries, and have higher rates of infection. The problem of slower hematopoietic recovery post-UCBT has been addressed using different approaches: infusion of two CB units, ex-vivo expansion of CB, transplantation of a UCB combined with a selected CD34+ peripheral stem cell unit from an haplo-identical donor. Intrabone (IB) injection is a known emergency access route for infusion of fluids and drugs in children. Frassoni et al published a study on the IB injection of a single unit of CB into 32 adult patients (Frassoni F, et al. Lancet Oncol. 2008) and showed a neutrophil (0.5x10^9/L) and platelet (20x10^9/L) recoveries with a median of 23 and 36 days, respectively, with a median nucleated cell dose of only 2.6 x 10^7 cells/kg. These results have been confirmed in a retrospective study comparing IB infusion of CB with infusion of two units of CB in adult patients (Rocha V, et al. Transplantation. 2013). The only data of IB infusion in pediatric patients is a case report of 5 patients (Saglio F, et al. J Pediatr Hematol Oncol. 2012). In order to confirm the role of IB infusion of CB to improve hematopoietic reconstitution after UCBT in pediatric patients, we started a Phase II single arm, exploratory clinical trial (NCT01711788). Our primary hypothesis is that use of IB infusion of CB reduces stem cell trapping seen with IV infusion, maximizing the number of stem cells and providing a faster short- and robust long-term engraftment. Inclusion criteria includes age up to 21 years, diagnosis of hematopoietic disorders (malignant or not), availability of a single CB with at least 3 x 10^7 nucleated cells (NCs)/kg at freezing (use of two CB units is allowed provided a single CB unit fulfilling the above criteria is not available), and use of a myeloablative-conditioning regimen. On the day of UCBT, frozen CB unit is thawed, washed and re-suspended in 20 ml of a saline/albumin solution and aliquoted into four 5-ml syringes. Patient is sedated with propofol and ketamine according to the current protocol for sedation in children. After sedation, a first aliquot of CB stem cell suspension is injected into the bone marrow, followed by a of 0.5-1 ml saline solution rinse. This procedure is repeated for all remaining aliquots at different places and can be performed in one or both iliac crests, depending on patient size. Each injection is performed within a 2-minute timeframe. If patient requires two CB units, one unit is infused IB while the second unit is infused IV after recovery from sedation. G-CSF is given from D+7. A total of 12 patients has been included since Nov/2012. Eight were male, and median age was 7 (2 - 15) years. Diagnosis were AML (n=6), ALL (n=4) and sickle cell anemia (n=2). Most UCB were unrelated (n=10) and 6/6, 5/6 and 4/6 HLA matching comprised four, five and three UCBT. Busulfan-based conditioning was used in eight patients. Ten patients received a single unit UCB. Median NC infused was 3.4 (2.17-8.4) x 10^7/kg. There was no toxicity related to IB infusion. Engraftment occurred in 10 out of 12 patients and median time to engraftment (neutrophil ≥ 0.5x10^9/L) was 14.5 days. Platelet recovery (≥ 50x10^9/L) occurred in just 6/12 patients (due mainly to early relapse) and median time to recovery was 41 (28-77) days. Three patients presented a grade II aGVHD. There were three relapses. Ten out of twelve patients are alive, one patient died from UCBT complication (ARDS) and other from relapse. In conclusion, IB infusion of UCB is feasible in pediatric patients without any particular toxicity and there is a positive impact on neutrophil recovery. Inclusion of more patients are needed to confirm the impact of IB-UCBT on platelet recovery, duration of hospitalisation, and survival. IB-UCBT might be a more affordable alternative to improve hematopoietic recovery comparing to other methods of UCB expansion. Disclosures No relevant conflicts of interest to declare.

Objectif Le but de cette etude etait de valider la version francophone de l’echelle « Non-Communicating Children’s Pain Checklist – Postoperative Version » (NCCPC-PV), appelee la grille d’evaluation de la douleur-deficience intellectuelle (GED-DI).

Objective To develop evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis (UPIA). Methods 697 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2008-9 consisting of three separate rounds of discussions and modified Delphi votes. In the first round 10 clinical questions were selected. A bibliographic team systematically searched Medline, Embase, the Cochrane Library and ACR/EULAR 2007-2008 meeting abstracts. Relevant articles were reviewed for quality assessment, data extraction and synthesis. In the second round each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. Results A total of 39 756 references were identified, of which 250 were systematically reviewed. Ten multinational key recommendations about the investigation and follow-up of UPIA were formulated. One recommendation addressed differential diagnosis and investigations prior to establishing the operational diagnosis of UPIA, seven recommendations related to the diagnostic and prognostic value of clinical and laboratory assessments in established UPIA (history and physical examination, acute phase reactants, autoantibodies, radiographs, MRI and ultrasound, genetic markers and synovial biopsy), one recommendation highlighted predictors of persistence (chronicity) and the final recommendation addressed monitoring of clinical disease activity in UPIA. Conclusions Ten recommendations on how to investigate and follow-up UPIA in the clinical setting were developed. They are evidence-based and supported by a large panel of rheumatologists, thus enhancing their validity and practical use.

The aim of the study was to test the validity of a French language version of the Non-Communicating Children's Pain Checklist - Postoperative Version (NCCPC-PV): grille d'évaluation de la douleur-déficience intellectuelle (GED-DI).We assessed the intensity of pain in 87 intellectually disabled surgical patients recruited in four Canadian and French hospitals in the pre- and post-operative settings using the GED-DI, a 100-mm visual analogue pain scale (VAS) and the Rosen sedation scale. The validity of the GED-DI was measured by the difference in scores between pre- and postoperative conditions. The checklist was made up of 30 items divided into seven subgroups. Items were rated from 0 to 3 for a total score ranging from 0 to 90 points.The mean (standard deviation) age of the patients was 17 (11) yr and the mean mental age 24.5 (24) months. The total GED-DI score was 6.1 (4.9) pre- and 13.4 (11.2) post-surgery (P 0.001). All subgroups had a higher score after surgery (P 0.001). The receiver operating characteristic (ROC) curves, comparing the absence of pain to mild pain scores and moderate to severe pain scores, showed a cutoff at 6 (mild pain) and 11 (moderate to severe pain).The French version of the NCCPC-PV can be used to assess pain in non-communicating patients with intellectual disabilities in a postoperative setting. It has good content validity, as the total pre-surgery score for the GED-DI was significantly lower than the postoperative score, and showed a good concurrent validity when compared to the VAS.

Rheumatoid arthritis (RA) is the most common inflammatory arthritis affecting approximately 1% of the population. The diagnosis of RA still evokes a picture of a patient crippled with bilateral, symmetric deformities of hands and feet in the mind of most doctors. Less than 15 years ago, RAwas regarded as a chronic destructive disease leading to joint deformities and severe functional decline with work disability reported in 60% of patients after 10 years [1]. As a systemic disorder, it has also been linked to multiple organ system complications and increased mortality, predominantly due to accelerated cardiovascular disease. Fortunately, over the last two decades, significant advances in the treatment and management of RA have been made and are changing the way we perceive RA. New treatment strategies have shown their ability to slow disease progression. New biologic agents that have been shown to be able to arrest joint damage are now available. Moreover, when these agents are used in early disease, a significant proportion of patients can achieve remission, a state with no apparent disease activity or inflammation. Another major advance has been the recognition of the importance of early treatment, emphasizing the need for early diagnosis. Therefore, rheumatologists ideally see patients within weeks of symptoms onset, and as a result, the clinical course and treatment of RA have undergone major changes. Clinical presentation: what has changed?

Objective Pain management in children has improved substantially over the last few years but continues to vary widely across institutions. Our objective was to describe the evaluation and treatment of pain in paediatric patients in two hospitals (Robert Debre in Paris, France, and Sainte-Justine, Montreal, Canada) and to compare conformity with quality criteria. Method Retrospective medical chart of a total of 200 patients with uncomplicated appendectomy, spinal fusion, ureteroneocystostomy, or laparoscopic cholecystectomy were analysed, with special attention to nurses’ entries, prescriptions, and medication administration sheets. Main outcome measure Patient characteristics and variables pertaining to pain evaluation (tool and result) and treatment (date, prescription and administration details) were collected. Quality criteria for evaluating conformity with guidelines were taken from the literature. Any change in medication, dosage, or dosing interval was taken as a new prescription. Results About 929 prescriptions and 2,388 numerical pain scores were recorded for 200 patients. Pain was recorded at 70.8% of vital-sign evaluations at the Robert-Debre Hospital compared to 30.9% at the Sainte-Justine hospital (P

Interstitial pneumonitis is a well documented, rare complication of methotrexate (MTX). We describe a patient with rheumatoid arthritis (RA) taking MTX for more than 3 years who then developed severe interstitial pneumonitis after a third infliximab infusion. Other similar cases are reviewed. Infliximab may potentiate pulmonary toxicity of MTX.

Rheumatoid arthritis (RA) is an autoimmune disease characterised by synovial inflammation that can lead to joint damage through bone and cartilage destruction, loss of function and decreased quality of life. Fortunately, over the past few years, we have witnessed major advances in the management of RA with new agents and treatment strategies that have improved outcomes and made remission become a realistic goal. True remission has been defined as a state where there is no evidence of disease activity with complete resolution of signs and symptoms as well as arrest of joint damage and disability progression. Hence, inhibition of radiographic progression has become a major therapeutic goal given its direct relationship to patient function and quality of life.1 Clinical remission can be achieved with disease-modifying antirheumatic drugs (DMARD) alone or may need a combination of DMARDs and biologic agents. Radiographic remission is more complex as we have learned from the probability plots that the mean/median change of radiographic progression is accounted for by a minority of patients who progress radiographically. Indeed, regardless of the therapy used, approximately 50% of patients will not show radiographic progression over 2–3 years; This percentage increases up to 75–85% of patients receiving combination therapy, and those who do progress, progress less than patients on methotrexate alone.2 It has long been thought that prevention of radiographic progression was achieved through the eradication of synovial inflammation, and that antitumour necrosis factor (TNF) agents were more effective at reducing structural progression through a better control of inflammation. However, recent posthoc …

Background We previously reported that immunological parameters can predict 6 month response to treatment in early rheumatoid arthritis independently of the drug received. Normal naive CD4 T cells frequency, notably predicted patient ability to achieve remission. The aim of the current study is to determine whether T cell subset analysis (within 4 h of blood collection) can predict remission and/or lack of response to methotrexate (MTX) followed by MTX-escalation and/or addition of other disease-modifying antirheumatic drugs (DMARDs) with the aim of inducing remission (treat to target concept). Methods 28 patients with Results 14/28 patients (50%) achieved remission (DAS28 Responses from the 31 patients in the TNF-I group were: 14 (45%) patients achieved remission at 6 months and 18 (58%) at 12 months Only one patients did not respond at 6 months but 4 (13%) at 12 months. No single predictor of remission or lack of response could be found in this group. Six patients in this TNF-i group combined the lack of response to MTX-prognostic factors (IRC>3% and DAS28>4 at baseline. Only one achieved remission at 6 months. Seven patients treated with TNF-i lacked the good MTX-prognostic factors (naive T cell Conclusion These data are preliminary however they suggested that, in patients that lack good MTX-prognostic factors, the use of TNF-inhibitor may improve remission rate. They further confirmed previous findings and suggest that transferring flow cytometry protocols from a research lab to routine hospital service may be useful.

Background T cell subset dys-regulation was previously shown to predict the ability to achieve remission in early rheumatoid arthritis (RA), independently of the treatment received. Naive cells frequency were the most discriminative circulating T cells although cytokine activated T cells (IRC) were informative. The aim of the current study is to determine whether T cell subset analysis performed within 4 h of blood collection can discriminate early between patients that will evolve towards UA or RA. Methods 70 patients with Results Using newly developed 2010-RA criteria for diagnostic, 49 of the 70 patients evolved to RA, 11 remaining unclassified (UA). RA was associated with younger age (p=0.05, median 46 years compared to UA 65 years), higher DAS28 (p=0.008) compared to UA. There was no difference in symptom duration or RF. Naive T cells are difficult to measure in the sixth decade as they decrease with age (R=−0.672, p 3.2 (p=0.022), CRP>10 mg/l (p=0.026) and reduced naive T cells (p=0.041). Patients fulfilling these three clinical RA parameters were all RA. In the 32 patients failing one or two of these three parameters, reduced naive T-cells identified 94% of these patients as RA. UA patients showed normal naive T-cells in 87% patients analysed. Conclusion There is clear immunological difference between UA and RA diagnosed using the new 2010-criteria: loss of naive T cells appear particularly important with the appearance of IRC. Treg appear to have limited predictive value.

Background The order of use of biologic agents after failing a TNF inhibitor is still a question for debate. Phase III trial data in TNF-IR patients show comparable efficacy results across biologic agents and limited head-to-head studies have been published. Prospective registries offer a unique opportunity to observe the effectiveness (combined evaluation of efficacy and safety profile over time) of these agents in a clinical setting. Objectives To evaluate if patients with rheumatoid arthritis (RA) treated with rituximab (RIT) after failing a first or a second anti-TNF agents (TNF-IR) have a different drug retention rate than patients similarly prescribed anti-TNF agents (pooled adalimumab, etanercept or infliximab) and compare the treatment strategies of using RIT as second or third biologic treatment. Methods Data from TNF-IR RA patients prescribed adalimumab (ADA), etanercept (ETA), infliximab (INF) or rituximab (RIT) as second or third biologic agents on or after January 1st 2007 was extracted and subjects taking either ADA, ETA or INF were pooled to form the anti-TNF cohort. Baseline demographics included age, disease duration, HAQ-DI, fatigue and pain visual analog scale evaluations (VAS), TJC, SJC, DAS 28 ESR and SDAI. Five-year drug retention rates were estimated and compared using Kaplan-Meier survival estimates. Statistical analysis was performed using SAS version 9.3. RHUMADATA® is a clinical database and registry used in daily clinical practice at the IRM and CORQ. Results The data from 226 RA patients were extracted, 153 and 73 having respectively failed a first and a second anti-TNF agent. No clinically significant differences in baseline variables were observed between treatment groups in second and third intention. The 5 year retention rates of second line RIT and anti-TNF use were 74% and 36% respectively (Log-rank p=0.002). In patients having failed two anti-TNF, subsequent use of RIT and anti-TNF agents respectively demonstrated 5 year retention rates of 48% and 24% (Log-rank p=0.004). Although numerically superior (74% vs 48%) second line use of RIT did not reach statistical difference when compared to third line usage. Conclusions As a second line agent, in TNF-IR patients, RIT demonstrates a better 5 year retention rate than anti-TNF agents. As third line therapy, RIT is also statistically superior to anti-TNF agents. Although no statistical difference was demonstrated between second and third line RIT use, it is evident that positioning RIT as second line offers a better long term outcome. References S.M. Du Pan, A. Scherer, C. Gabay, A. Finckh. Differential drug retention between anti-TNF agents and alternative biological agents after inadequate response to an anti-TNF agent in rheumatoid arthritis patients. Annals of the rheumatic diseases 01/2012; 71(6):997-9. Acknowledgements The Rhumadata clinical database and registry is supported by unrestricted grant from Abbvie Canada, Amgen Canada, BMS Canada, Pfizer Canada, Roche Canada. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.1890