Last Observation Carried Forward Research Articles

Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study.

BackgroundComplications of chronic anal fissure (CAF) treatments are prompting interest in lower-risk therapies. This study was conducted to compare nitroglycerin (NTG) 0.4% ointment with placebo for pain associated with CAF.MethodsIn this randomized, double-blind, placebo-controlled trial, patients with one CAF and moderate-to-severe pain (≥50 mm on a 100 mm visual analog scale [VAS]) received 375 mg NTG 0.4% (1.5 mg active ingredient) or 375 mg placebo ointment applied anally every 12 hours for 21 days. The primary end point was change from baseline VAS score in 24-hour pain averaged over days 14–18. Review of data from patients who withdrew early was blinded to treatment. To control for the confounding effects of analgesics, all patients received 650 mg acetaminophen for headache prophylaxis before each application.ResultsA total of 247 patients were enrolled (NTG, n = 123; placebo, n = 124). The prespecified baseline observation carried forward (BOCF) analysis found no significant difference between groups; however, a last observation carried forward (LOCF) analysis showed a significant advantage for NTG. A post hoc analysis (LOCF/BOCF hybrid) demonstrated a significant adjusted mean difference of −7.0 mm in favor of NTG 0.4% (95% CI −13.6, –0.4; P = .038). Headache was the most common adverse event in the NTG (69.9%) and placebo (47.6%) groups.ConclusionsThis was the first placebo-controlled study that also controlled for the confounding effects of analgesics used to treat NTG-induced headache. In patients with moderate-to-severe CAF pain, NTG 0.4% ointment effectively reduced CAF pain compared with placebo.Trial registrationClinicalTrials.gov, NCT00522041

Treatment persistence and changes in fracture risk, back pain, and quality of life amongst patients treated with teriparatide in routine clinical care in France: Results from the European Forsteo Observational Study

ObjectivesThe European Forsteo Observational Study assessed the clinical fracture incidence, back pain, quality of life (QoL), and treatment persistence amongst post-menopausal women, who were prescribed teriparatide in routine care in eight European countries. We present the results for France, with health-insurance reimbursement criteria channel teriparatide to women with severe disease and limit treatment to 18months. MethodsA representative sample of women initiating teriparatide in France was followed in routine care for 36months. We described patients’ characteristics at baseline and persistence to teriparatide (Kaplan–Meier analysis), fracture incidence, back pain, and QoL (EQ-5D) at baseline, 18 and 36months follow-up (last-observation-carried-forward (LOCF) and mixed-models-for-repeated-measures (MMRM). ResultsOne hundred and sixteen rheumatologists included 309 patients, of whom 290 (93.9%) had at least one follow-up visit. Women's mean age (standard deviation) was 74.5years (7.4) and 296 (95.8%) had greater or equal to two vertebral fractures prior to teriparatide initiation. Clinical fracture incidence, mainly vertebral fractures, decreased around 6months after teriparatide initiation, and was sustained at 36months (P=0.013) when most patients were treated by anti-resorptives. Back pain and EQ-5D measures improved significantly at 18 and 36months (P<0.0001) in the LOCF analyses but did not improve in the EQ-5D VAS measure after covariate adjustment in the MMRM model. Median treatment duration was 17.4months. ConclusionFrench women initiating teriparatide in routine care had severe osteoporosis and showed good treatment persistence, consistent with France's insurance reimbursement criteria. Improvements in fracture risk and back pain began soon after treatment and was maintained at 36months follow-up.

FRI0082 Development of impairment, disability, radiological damage, comorbidity and mortality over 20 years in rheumatoid arthritis patients

ObjectivesTo study the development of impairment, disability, radiological damage, comorbidity and mortality over 20 years in a cohort followed prospectively from diagnosis.Methods183 RA patients diagnosed between 1985 and 1989 were...

THU0213 The Combination Therapy with Dose Escalation and Interval Shortening of Infliximab Makes Better Response to Patients with Rheumatoid Arthritis who Were Loss of Efficacy Against Infliximab

BackgroundThe anti-TNF agents prevents joint destruction, and brought drastic change on rheumatoid arthritis treatment, but some patients have to discontinue these drugs due to inadequate response. In Infliximab (IFX) standard...

OP0177 Efficacy and safety of high vs. low dose etanercept in children with JIA

BackgroundThe TNF Alpha (TNFA) antagonist etanercept (ETN) is approved for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in a dose of 0.8 mg/kg/week. The existing data for TNFA other...

OP0155 Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in early rheumatoid arthritis: 2-year quality of life results of the randomised, controlled swefot trial

BackgroundIn RA, direct comparisons of the quality of life effects associated with different therapies remain sparse.ObjectivesTo compare EuroQol 5-Dimensions (EQ-5D) utility and quality-adjusted life-years (QALYs) over 21 months in patients...

SAT0111 Description of Glucocorticoid Sparing Effect in Rheumatoid Arthritis (RA) Patients Treated by Tocilizumab (TCZ) in Real Life: An Interim Analysis of the Spare-1 Study

BackgroundAlthough glucocorticoid treatment may be appropriate in RA patients, there is general agreement that glucocorticoid therapy sparing is desirable when possible (1, 2). The safety of corticosteroids is duration and...

AB0563 Impact of the history and the type of previous biologic treatment on abatacept efficacy in rheumatoid arthritis patients

BackgroundAbatacept (ABT), a selective co-stimulation modulator, is the first in a new class of biologic agents for the treatment of rheumatoid arthritis (RA). Since ABT is often used as second...

THU0117 Abatacept can demonstrate maximum efficacy without background methotrexate treatment in rheumatoid arthritis

BackgroundAbatacept (ABT), a selective co-stimulation modulator, is the first in a new class of biologic agents for the treatment of rheumatoid arthritis (RA) that inhibits T cell activation by binding...

THU0192 5-Year Results from the Rapid 1 Trial and Open-Label Extension: Long-Term Safety and Efficacy of Certolizumab Pegol in Combination with Methotrexate in the Treatment of Rheumatoid Arthritis

BackgroundIn the RAPID 1 randomized clinical trial (RCT; NCT00152386),1 certolizumab pegol (CZP) every 2 weeks (Q2W) plus MTX over 52 weeks (wks) provided rapid improvements in signs and symptoms and...

FRI0219 Disease severity, no steroid use and type ii diabetes predict response to anakinra (kineret®) in patients with rheumatoid arthritis

Background458 patients with rheumatoid arthritis (RA) and unsatisfactory response to DMARDs alone and/or TNFα blocking agents were treated with the IL-1 receptor antagonist anakinra. The initial analysis showed no difference...

SAT0138 Prediction of Response to Tocilizumab Using Biomarkers (Interleukin-1 Beta, D-Dimer and Fibrinogen) in Patients with Rheumatoid Arthritis

BackgroundBetter objective measures are needed to evaluate the responses to biologics in rheumatoid arthritis (RA) patients because such responses are not predictable and useful indicators remain unclear. Furthermore, to predict...

AB0574 Evaluation of the efficacy of tocilizumab toward the patients with active rheumatoid arthritis of nagasaki prefecture, japan

BackgroundTocilizumab (TCZ) is a humanized anti-interleukin 6 receptor (IL-6R) monoclonal antibody and it was approved in Japan as an antirheumatic drugs in 2008. Evidence of the efficacy of TCZ in...

SAT0118 The Clinical Outcome of Abatacept Treatment in Biologic NaÏVe Patients with Rheumatoid Arthritis in Multi-Center Clinical Practice

BackgroundThe 2008 American College of Rheumatology Recommendations has been updated last year, abatacept (ABT) has become available as the first biologic agent for patients with established RA1. The efficacy and...

AB0551 The use and effectiveness of rituximab in patients with rheumatoid arthritis observational study: Corrona registry

BackgroundLittle is known regarding the use and effectiveness of rituximab (RTX) in patients with rheumatoid arthritis (RA) in the United States. Using a cohort of 26,877 patients with RA from...

SAT0145 Timing and magnitude of initial response to certolizumab pegol in a broad population of patients with active rheumatoid arthritis predicts likelihood of LDA at week 28

BackgroundIt has previously been shown that the majority of patients (pts) with active rheumatoid arthritis (RA) have a rapid response to certolizumab pegol (CZP) and that lack of improvement in...

AB0946 Anti-TNF treated psoriatic arthritis: Course of composite disease activity measures and clinical core domains

BackgroundPsoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, and The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has defined clinical core domains for assessment...

LB0001 Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24 week results of a phase 3 double blind randomized placebo-controlled study (rapid-PSA)

BackgroundCertolizumab pegol (CZP) is a PEGylated humanized Fc-free anti-TNF that is clinically effective in rheumatoid arthritis [1]; this is the first report of clinical efficacy and safety of CZP in...

THU0152 How should the primary endpoint be analysed in rheumatoid arthritis trials which mandate rescue prior to the clinical endpoint? Analysis of three phase 3 trials of tofacitinib

BackgroundIn the 21st century, with the availability of effective therapies for rheumatoid arthritis (RA), the conduct of double-blind placebo (PBO)-controlled studies has changed dramatically. PBO therapy is continued for shorter...

A double‐blind, placebo‐controlled study of adjunctive calcitonin nasal spray in acute refractory mania

Calcitonin, a neuropeptide, has been shown in preliminary double-blind trials to reduce agitation in patients with acute mania. Given that it has effects similar to those of lithium and anticonvulsants on modulation of second-messenger signaling pathways and stabilization of neuronal membranes, this study examined the efficacy of calcitonin nasal spray in treating acute manic symptoms in patients with treatment-resistant mania using a double-blind, placebo-controlled design. A total of 46 hospitalized patients experiencing either a manic or a mixed episode, who were refractory to treatment with adequate doses of either a mood stabilizer or an antipsychotic, or a mood stabilizer/antipsychotic combination, and had a score of ≥16 on the Young Mania Rating Scale (YMRS), were randomized to receive adjunctive nasal calcitonin 200 IU (n = 24) or saline (n = 22) spray for three weeks. The primary efficacy measure was the change in YMRS scores using the last observation carried forward (LOCF) method. The clinical and demographic characteristics were similar between the groups. Patients had a mean YMRS score of 26 in the placebo group and a mean score of 25 in the calcitonin group. There were no significant differences in YMRS scores or percentage responders at three weeks between patients who received calcitonin and those who received placebo. There were also no significant differences in change scores on any other scales. Few patients experienced any adverse events. This study does not support the use of nasal calcitonin in the treatment of treatment-resistant mania.