Topical Cyperus rotundus essential oil for treatment of axillary hyperpigmentation: a randomized, double-blind, active- and placebo-controlled study.

BACKGROUND: The oil of the grass Cyperus rotundus (purple nutsedge) is an effective and safe treatment option for a variety of conditions. It has anti-inflammatory and antipigmenting properties. There have been no clinical trials comparing topical C. rotundus oil with skin-lightening treatments for axillary hyperpigmentation. AIM: To assess the efficacy of C. rotundus essential oil (CREO) in treating axillary hyperpigmentation, and compare with another active treatment hydroquinone (HQ) and a placebo (cold cream) in this study. METHODS: The study included 153 participants, who were assigned to one of three study groups: CREO, HQ group or placebo group. A tri-stimulus colorimeter was used to assess pigmentation and erythema. Two independent experts completed the Physician Global Assessment, and the patients completed a self-assessment questionnaire. RESULTS: CREO had significantly (P < 0.001) better depigmenting effects than HQ. CREO and HQ did not differ significantly in terms of depigmentation effects (P > 0.05); however, there were statistically significant differences in anti-inflammatory effects and decrease in hair growth (P < 0.05) in favour of CREO. CONCLUSIONS: CREO is a cost-effective and safe treatment for axillary hyperpigmentation.

Fluocinolone Acetonide Intravitreal Implant for Treating Recurrent Non-infectious Uveitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

The National Institute for Health and Care Excellence (NICE) invited Alimera Sciences, the company manufacturing fluocinolone acetonide intravitreal implant (FAc) 0.19 mg (tradename ILUVIEN®), to submit evidence on the clinical and cost-effectiveness of FAc for treating recurrent non-infectious uveitis. Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre + , was commissioned to act as the independent Evidence Review Group (ERG). This paper contains a summary of the clinical and cost-effectiveness evidence submitted by the company, the ERG's critique on the submitted evidence, and the guidance issued by the NICE Appraisal Committee (AC). The company submission (CS) was mainly informed by the PSV-FAI-001 trial in which FAc was compared with (limited) current practice [(L)CP], which was not considered to be representative of UK clinical practice by the ERG. There was no comparison of FAc to any treatment listed in the final scope, and especially to the dexamethasone intravitreal implant (dexamethasone), which was considered to be a relevant comparator by the AC. The primary outcome of the PSV-FAI-001 was recurrence of uveitis in the treated eye. Most of the events for the primary outcome were imputed during the PSV-FAI-001 trial, which probably led to an overestimation of the number of recurrences of disease, and a biased estimate of the relative effectiveness of FAc versus (L)CP. Finally, the place of FAc in the treatment pathway was not clearly defined by the company. Substantial uncertainty surrounded the cost-effectiveness results due to the shortcomings of the clinical evidence. Additionally, the quality of life of patients was not measured during the PSV-FAI-001 trial and long-term effectiveness data of FAc were lacking. The ERG adjusted several issues identified in the CS and added dexamethasone as a comparator in the decision analytic model. The ERG presented multiple analyses as base-cases because several elements of the assessment remained uncertain. The fully incremental ERG results ranged from dexamethasone (extendedly) dominating FAc (when assuming a hazard ratio of 1 or 0.7 for dexamethasone versus FAc) to an incremental cost-effectiveness ratio (ICER) of £30,153 per quality-adjusted life-year (QALY) gained for FAc versus (L)CP [when assuming a hazard ratio of 0.456 for dexamethasone versus (L)CP]. The ICER of FAc versus (L)CP ranged from £12,325 to £30,153 per QALY gained. After a second AC meeting where alternative company scenarios comparing FAc with dexamethasone were considered by the AC, the AC concluded that "the results of the company's analyses ranged from the fluocinolone acetonide implant being dominant (that is, it was more effective and costs less), to an ICER of £29,461 per QALY gained, and most of the ICERs were below £20,000 per QALY gained". Therefore, the AC recommended FAc as a cost-effective use of National Health Service (NHS) resources for treating recurrent non-infectious uveitis affecting the posterior segment of the eye in the final TA590 guidance (published July 2019).

Budesonide with multi-matrix technology as second-line treatment for ulcerative colitis: evaluation of long-term cost-effectiveness in the Netherlands.

AIMS: Budesonide with multi-matrix technology (MMX) is an oral corticosteroid, shown to have high topical activity against ulcerative colitis (UC) while maintaining low systemic bioavailability with few adverse events. The aim of this study was to evaluate the cost-effectiveness of budesonide MMX versus commonly used corticosteroids, in the second-line treatment of active mild-to-moderate UC in the Netherlands. MATERIALS AND METHODS: An eight-state Markov model with an 8 week cycle length captured remission, four distinct therapy stages, hospitalization, possible colectomy and mortality. Remission probability for budesonide MMX was based on the CORE-II study. Population characteristics were derived from the Dutch Inflammatory Bowel Disease South Limburg cohort (n = 598) and included patients with proctitis (39%), left-sided (42%) and extensive disease (19%). Comparators (topical budesonide foam and enema, oral budesonide and prednisolone) were selected based on current Dutch clinical practice. Treatment effects were evaluated by network meta-analysis using a Bayesian framework. Cost-effectiveness analysis was performed over a 5 year time horizon from a societal perspective, with costs, health-state and adverse event utilities derived from published sources. Outcomes were weighted by disease extent distribution and corresponding comparators. RESULTS: Budesonide MMX was associated with comparable quality-adjusted life year (QALY) gain versus foam and oral formulations (+0.01 QALYs) in the total UC population, whilst being cost-saving (EUR 366 per patient). Probabilistic sensitivity analysis evaluated an 86.6% probability of budesonide MMX being dominant (cost-saving with QALY gain) versus these comparators. Exploratory analysis showed similar findings versus prednisolone. LIMITATIONS: Differing definitions of trial end-points and remission across trials meant indirect comparison was not ideal. However, in the absence of head-to-head clinical data, these comparisons are reasonable alternatives and currently offer the only comparison of second-line UC treatments. CONCLUSIONS: In the present analysis, budesonide MMX was shown to be cost-effective versus comparators in the total UC population, for the second-line treatment of active mild-to-moderate UC in the Netherlands.

Health outcomes and cost-effectiveness of certolizumab pegol in the treatment of Crohn's disease.

Crohn's disease (CD) causes chronic inflammation of the gastrointestinal tract and leads to fluctuations between active disease and remission. Certolizumab pegol is one of the newer biological treatments for patients with moderate-to-severe CD. Certolizumab pegol was shown to be effective in CD patients achieving response and remission in both randomized and non-randomized studies, and is an alternative biological treatment for CD. The available data show that certolizumab pegol achieves similar therapeutic efficacy and health-related quality of life scores in CD patients as the other biological agents, but at a higher cost, if dose escalation of other biologics is not considered. Considering subcutaneous self-administration, and lower number and frequency of injections, patients may prefer certolizumab pegol over the other biological treatments.

Opposite drug prescription and cost trajectories following integrative and conventional care for pain--a case-control study.

OBJECTIVES: Pharmacotherapy may have a limited role in long-term pain management. Comparative trajectories of drug prescriptions and costs, two quality-of-care indicators for pain conditions, are largely unknown subsequent to conventional or integrative care (IC) management. The objectives of this study were to compare prescribed defined daily doses (DDD) and cost of first line drugs for pain patients referred to conventional or anthroposophic IC in Stockholm County, Sweden. METHODS: In this retrospective high quality registry case-control study, IC and conventional care patients were identified through inpatient care registries and matched on pain diagnosis (ICD-10: M79), age, gender and socio-demographics. National drug registry data was used to investigate changes in DDD and costs from 90/180 days before, to 90/180 days after, index visits to IC and conventional care. The primary selected drug category was analgesics, complemented by musculo-skeletal system drugs (e.g. anti-inflammatories, muscle relaxants) and psycholeptics (e.g. hypnotics, sedatives). RESULTS: After index care visits, conventional care pain patients (n = 1050) compared to IC patients (n = 213), were prescribed significantly more analgesics. The average (95% CI) group difference was 15.2 (6.0 to 24.3), p = 0.001, DDD/patient after 90 days; and 21.5 (7.4 to 35.6), p = 0.003, DDD/patient after 180 days. The cost of the prescribed and sold analgesics was significantly higher for conventional care after 90 days: euro/patient 10.7 (1.3 to 20.0), p = 0.025. Changes in drug prescription and costs for the other drug categories were not significantly different between groups. CONCLUSIONS: Drug prescriptions and costs of analgesics increased following conventional care and decreased following IC, indicating potentially fewer adverse drug events and beneficial societal cost savings with IC.

Obesity and psoriasis: inflammatory nature of obesity, relationship between psoriasis and obesity, and therapeutic implications.

Obesity, particularly abdominal obesity, is currently considered a chronic low-grade inflammatory condition that plays an active role in the development of the pathophysiologic phenomena responsible for metabolic syndrome and cardiovascular disease through the secretion of proinflammatory adipokines and cytokines. In recent years clear genetic, pathogenic, and epidemiologic links have been established between psoriasis and obesity, with important implications for health. The relationship between the 2 conditions is probably bidirectional, with obesity predisposing to psoriasis and psoriasis favoring obesity. Obesity also has important implications in the treatment of psoriasis, such as a greater risk of adverse effects with conventional systemic drugs and reduced efficacy and/or increased cost with biologic agents, for which dosage should be adjusted to the patient's weight.

Catastrophic health expenses and impoverishment of households of patients with rheumatoid arthritis.

BACKGROUND: The cost of certain diseases may lead to catastrophic expenses and impoverishment of households without full financial support by the state and other organizations. OBJECTIVE: To determine the socioeconomic impact of the rheumatoid arthritis (RA) cost in the context of catastrophic expenses and impoverishment. PATIENTS AND METHODS: This is a cohort-nested cross-sectional multicenter study on the cost of RA in Mexican households with partial, full, or private health care coverage. Catastrophic expenses referred to health expenses totaling >30% of the total household income. Impoverishment defined those households that could not afford the Mexican basic food basket (BFB). RESULTS: We included 262 patients with a mean monthly household income (US dollars) of $376 (0­18,890.63). In all, 50.8%, 35.5%, and 13.7% of the patients had partial, full, or private health care coverage, respectively. RA annual cost was $ 5534.8 per patient (65% direct cost, 35% indirect). RA cost caused catastrophic expenses in 46.9% of households, which in the logistic regression analysis were significantly associated with the type of health care coverage (OR 2.7, 95%CI 1.6­4.7) and disease duration (OR 1.024, 95%CI 1.002­1.046). Impoverishment occurred in 66.8% of households and was associated with catastrophic expenses (OR 3.6, 95%CI 1.04­14.1), high health assessment questionnaire scores (OR 4.84 95%CI 1.01­23.3), and low socioeconomic level (OR 4.66, 95%CI 1.37­15.87). CONCLUSION: The cost of RA in Mexican households, particularly those lacking full health coverage leads to catastrophic expenses and impoverishment. These findings could be the same in countries with fragmented health care systems.

Role of glucosamine in the treatment for osteoarthritis.

Over the last 20 years, several studies have investigated the ability of glucosamine sulfate to improve the symptoms (pain and function) and to delay the structural progression of osteoarthritis. There is now a large, convergent body of evidence that glucosamine sulfate, given at a daily oral dose of 1,500 mg, is able to significantly reduce the symptoms of osteoarthritis in the lower limbs. This dose of glucosamine sulfate has also been shown, in two independent studies, to prevent the joint space narrowing observed at the femorotibial compartment in patients with mild-to-moderate knee osteoarthritis. This effect also translated into a 50 % reduction in the incidence of osteoarthritis-related surgery of the lower limbs during a 5-year period following the withdrawal of the treatment. Some discrepancies have been described between the results of studies performed with a patent-protected formulation of glucosamine sulfate distributed as a drug and those having used glucosamine preparations purchased from global suppliers, packaged, and sold over-the-counter as nutritional supplements.

Role of biological therapy for inflammatory bowel disease in developing countries.

Inflammatory bowel disease (IBD) has become a global disease. Its incidence in developing countries is rising. In Asia, this has been attributed to the rapid modernisation and westernisation of the population. As IBD emerges in developing nations, there is a need to reconcile the most appropriate treatment for these patient populations from the perspectives of both disease presentation and cost. In the West, biological agents are the fastest-growing segment of the prescription drug market. They typically cost several thousand to several tens of thousands of dollars per patient per year. The healthcare systems in developing countries will struggle to afford such expensive treatments. Developing countries cover two-thirds of the earth's surface and are home to 3-5 billion inhabitants, constituting three-quarters of all humanity. If IBD emerges to the same extent in those countries as it has in the West, the need for biological therapy will increase dramatically, and the pharmaceutical industry, healthcare providers, patient advocate groups, governments and non-governmental organisations will have to discuss how to handle this. The authors propose that this dialogue should begin now with regard to (1) the major needs of patients with complicated IBD in developing countries, (2) the potential need for biological therapy in developing countries to treat IBD, (3) the necessary infrastructure for selecting patients with IBD who need biological therapy, and (4) medical/ethical issues limiting the use of biological therapy.

[On general practitioners' care of patients with asthma]. / HausärztlicheVersorgung von Patienten mit Asthma.

UNLABELLED: This review offers readers new aspects for the guideline-compliant care of asthma patients. Here, attention is focused on illustrating the bottlenecks in the administration of good and practicable therapeutic care and listing these as "major challenges for GPs". The interdisciplinary team of authors - consisting of three hospital-based pulmonologists, one pulmonologist in private practice, one internist in general practice, one pharmacist and one health economist discussed aspects of asthma therapy relevant in clinical practice. RESULTS AND CONCLUSIONS: Practicable results for the reader included an asthma pentagram, a graphic depicting the links and interactions between diagnosis, symptom management, communication, application and costs. From this emerged a consensus on four recommendations that can help GPs improve their care of their patients: (1) Whenever possible, have a specialist verifythe diagnosis. (2) Practice inhalation techniques with the patient and check up on their technique at regular intervals. (3) Monitor and fine-tune the therapeutic goals set down together with the patient. (4) Clearly define the (patient's) responsibilities and who is organizing care (communication between GP-specialist-patient-pharmacist-family members).

The two-compound formulation of calcipotriol and betamethasone dipropionate for treatment of moderately severe body and scalp psoriasis - an introduction.

Psoriasis is a common chronic inflammatory skin disease and many patients require lifelong treatment. Characteristic scaly, itchy, unsightly psoriatic lesions affect many body areas and most patients commonly experience scalp involvement. The cosmetic embarrassment of visible body lesions, inaccessibility of scalp skin to application of therapies and proximity of sensitive facial skin add to the challenges of most patients managing their psoriasis long term. Psoriasis can severely impact patients' quality of life. This can impact significantly on the patient. In economic terms patients may incur increased out-of-pocket expenditure or extended time away from work as a direct consequence of psoriasis, particularly in severe cases; In many countries, specialist review of patients provides pressures on hard-pressed services and the costs of psoriasis care are substantial, particularly in patients with severe recalcitrant psoriasis which may require lengthy inpatient admission. Around 80% of patients with psoriasis have mild to moderately severe disease and the majority are treated with topical medicines by their physician in primary care. Despite the availability of a wide range of treatment options, regimens have been unsatisfactory, associated with patient dissatisfaction, poor compliance and often safety concerns with long-term use. Evidence-based clinical guidelines aim to improve healthcare of patients and while there are such guidelines for psoriasis, to date the challenges of (and recommendations for) managing scalp psoriasis are often limited or missing from these treatment guidelines. In the following in-journal supplement, a connected suite of five papers focus on the use of topical therapies for the treatment of the person afflicted with psoriasis. This work harnesses robust evidence from randomised clinical trials (RCTs) of topical therapies commonly used in psoriasis patients and translates this into recommendations for the most appropriate treatment of patients with body or scalp psoriasis, from an efficacy, safety and cost-effectiveness perspective. Based upon systematic review and harnessing 'state of the art' evidence assessment methodologies, the modelling work suggests that the use of a two-compound formulation (TCF) product of calcipotriol and betamethasone dipropionate is the most appropriate treatment option for both body and scalp psoriasis. This Editorial acknowledges the results of any modelling exercise have limitations; indeed such limitations are acknowledged in each modelling contribution in this issue. With these caveats in mind, this introductory paper considers the implications of this research and distillation of the evidence. This work should guide cost-effective treatment choices for body and scalp psoriasis, assist in recommendations for management of scalp psoriasis in future iterations of psoriasis clinical guidelines and help primary care physicians striving to attain best outcomes in the care of the person with psoriasis.

Glucosamine sulphate in the treatment of knee osteoarthritis: cost-effectiveness comparison with paracetamol.

INTRODUCTION: The aim of this study was to explore the cost-effectiveness of glucosamine sulphate (GS) compared with paracetamol and placebo (PBO) in the treatment of knee osteoarthritis. For this purpose, a 6-month time horizon and a health care perspective was used. MATERIAL AND METHODS: The cost and effectiveness data were derived from Western Ontario and McMaster Universities Osteoarthritis Index data of the Glucosamine Unum In Die (once-a-day) Efficacy trial study by Herrero-Beaumont et al. Clinical effectiveness was converted into utility scores to allow for the computation of cost per quality-adjusted life year (QALY) For the three treatment arms Incremental Cost-Effectiveness Ratio were calculated and statistical uncertainty was explored using a bootstrap simulation. RESULTS: In terms of mean utility score at baseline, 3 and 6 months, no statistically significant difference was observed between the three groups. When considering the mean utility score changes from baseline to 3 and 6 months, no difference was observed in the first case but there was a statistically significant difference from baseline to 6 months with a p-value of 0.047. When comparing GS with paracetamol, the mean baseline incremental cost-effectiveness ratio (ICER) was dominant and the mean ICER after bootstrapping was -1376 euro/QALY indicating dominance (with 79% probability). When comparing GS with PBO, the mean baseline and after bootstrapping ICER were 3617.47 and 4285 euro/QALY, respectively. CONCLUSION: The results of the present cost-effectiveness analysis suggested that GS is a highly cost-effective therapy alternative compared with paracetamol and PBO to treat patients diagnosed with primary knee OA.

Cost-utility analysis of topical intranasal steroids for otitis media with effusion based on evidence from the GNOME trial.

OBJECTIVES: To estimate the cost-effectiveness of topical intranasal steroids for the treatment of otitis media with effusion (OME) in primary care from the perspective of the UK National Health Service. METHODS: An economic evaluation was conducted based on evidence from the double-blind, randomized, placebo-controlled GPRF [General Practice Research Framework] Nasal Steroids for Otitis Media with Effusion (GNOME) trial. Participants comprised 217 children aged 4-11 years who had at least one episode of otitis media or related ear problem in the previous 12 months and had tympanometrically confirmed bilateral OME. Children were randomly allocated to receive either mometasone furoate 50 microg or placebo spray once daily into each nostril for 3 months. The main outcome measure was the incremental cost per quality-adjusted life-year (QALY) gained for topical steroids compared with placebo. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative willingness to pay thresholds. RESULTS: Children receiving topical steroids accrued nonsignificantly higher costs (incremental cost/child: pound11, 95% confidence interval [CI]: - pound199 to pound222) and nonsignificantly fewer QALYs (incremental QALY gain/child: -0.0166, 95% CI: -0.0652 to 0.0320) than those receiving placebo. Topical steroids had a 24.19% probability of being cost-effective at a pound20,000 per QALY gained threshold, a 23.82% probability of being more effective and a 46.25% probability of being less costly. Sensitivity and subgroup analyses showed incremental costs and benefits to be highly sensitive to the methods used and the patient group considered, although differences between groups did not reach statistical significance in any analysis. CONCLUSIONS: Topical steroids are unlikely to be a cost-effective treatment for OME in general practice.

Cost-effectiveness of infliximab for the treatment of acute exacerbations of ulcerative colitis.

BACKGROUND: Infliximab has been shown to be efficacious in acute exacerbations of ulcerative colitis (UC). AIM: To evaluate the cost-effectiveness of infliximab treatment in patients hospitalised with acute exacerbations of UC. METHODS: A decision analysis model was constructed to simulate the progression of acute UC patients treated with infliximab induction regimen over 1 year. Infliximab treatment was compared with standard care, ciclosporin and surgery using transitions derived from infliximab and ciclosporin randomised trials. Costs and outcomes were discounted at 3.5%. Intermediate outcomes of colectomy and post-surgery complications were translated into the primary effectiveness measurement, which was quality-adjusted life years (QALYs) estimated using EQ-5D. One-way and probabilistic sensitivity analyses were performed to estimate the uncertainty around the results. RESULTS: The incremental cost effectiveness ratio (ICER) for infliximab was pound19,545 per QALY compared to ciclosporin, which in turn dominated standard care. Sensitivity analysis indicated patient body weight, utility estimates and treatment effect of alternative treatment strategies to be the most important factors affecting cost-effectiveness. CONCLUSION: Infliximab induction regimen appears to be a cost-effective treatment option for UC patients hospitalised with an acute exacerbation.

Paradoxical effects of cost reduction measures in managed care systems for treatment of severe psoriasis.

BACKGROUND: Insurance companies vary widely in their coverage policies for severe psoriasis therapies. Unfortunately, coverage policies for psoriasis therapies do not necessarily follow current treatment paradigms, such that more expensive second or third line treatments may be more easily obtained than first line treatments. METHODS: We reviewed insurance policy bulletins, statements of coverage/medical necessity, and prior authorization forms for three large insurance carriers regarding psoriasis treatment with biologic agents and phototherapy. A cost comparison was performed to estimate total costs to patients and insurer under the current system as well as a hypothetical system in which co-pays and deductibles are eliminated. Additionally, we reviewed the total cost to an insurer for placing a patient on a trial of home phototherapy before approving use of expensive biologics. RESULTS: Requirements for coverage for phototherapy treatments are often the same, if not more stringent, than those for biologics. On an annual per patient basis, insurance companies pay an estimated $5, $76, and $23,408 for home phototherapy, office phototherapy, and biologics, respectively. The first year cost to patients, however, is estimated to be $2,590, $3,040, and $920 for home phototherapy, office phototherapy, and biologics, respectively. An initial 3-month trial of home phototherapy yields a graded annual cost savings to insurers of $21,610 to $2,110 per patient. DISCUSSION: The evolution of psoriasis treatment has resulted in a paradoxical situation in which the use of lower-cost psoriasis treatments, with longer safety track records, is discouraged relative to newer options. If co-pays, deductibles, and prior authorization requirements that discourage phototherapy were reduced or eliminated, more patients and physicians would likely choose phototherapy over biologics. This has the potential to reduce overall healthcare costs for psoriasis management.

Do general practices which provide an acupuncture service have low referral rates and prescription costs? A pilot survey.

BACKGROUND: Studies by individual acupuncture practitioners have given an indication that offering acupuncture in primary care may reduce the need for referral to secondary care and reduce the costs of prescriptions. It would be informative to find out whether these findings can be supported by data from other practices. The aim of this study was to test the feasibility of surveying national data on referrals and prescribing. METHODS: Three primary care trusts (PCTs) were selected, and all practices within each trust were sent an email asking whether any member of the primary care team offered acupuncture, and if so how many appointments per week. Data on rates of referral to orthopaedic, physiotherapy, pain and rheumatology clinics were then sought from the PCT, both for the practices offering acupuncture and for the PCT as a whole. Similarly, data on costs of prescriptions for non-steroidal (NSAID) and non-opioid analgesic drugs were obtained from the Prescription Pricing Authority. RESULTS: Out of the 109 practices surveyed, a total of 14 (13%) offered acupuncture services to some extent. There was wide variation in provision between the different PCTs. The eight practices which offered at least one appointment per week for every 2000 registered patients were included in the analysis. The mean values (and SDs) for the three PCTs and for the eight acupuncture practices, respectively, were as follows: for referral to various clinics: orthopaedic 32.3 (16.2) and 27.4 (10.87); pain clinic 1.6 (1.3) and 2.8 (1.6); physiotherapy 13.4 (14.5) and 29.5 (10.0); and rheumatology 4.7 (2.3) and 6.4 (3.0). The mean values for costs of non-opioid analgesics were pound1820 ( pound442) and pound2008 ( pound762); and for NSAIDs were pound4148 ( pound269) and pound4476 ( pound1366), respectively. There were no trends towards a reduction of clinic referral or prescription costs. CONCLUSIONS: We have conducted the first survey of the effects of provision of acupuncture in UK general practice, using data provided by the NHS, and uncovered a wide variation in the availability of the service in different areas. We have been unable to demonstrate any consistent differences in the prescribing or referral rates that could be due to the use of acupuncture in these practices. The wide variation in the data means that if such a trend exists, a very large survey would be needed to identify it. However, we discovered inaccuracies and variations in presentation of data by the PCTs which have made the numerical input, and hence our results, unreliable. Thus the practicalities of access to data and the problems with data accuracy would preclude a nationwide survey.

Loss of treatment response to infliximab maintenance therapy in Crohn's disease: a payor perspective.

OBJECTIVES: To assess the incidence and economic implications of loss of treatment response among patients with Crohn's disease (CD) treated with infliximab maintenance therapy. METHODS: This was a retrospective observational study of infliximab response and costs among patients with CD using a large health-care claims database. Patients with CD receiving infliximab maintenance therapy with an initial response were selected from the Integrated Healthcare Information Services claims database (1999-2005). Patients' claim histories were used to identify patterns of response to infliximab treatment. Incidence of loss of response was estimated using Kaplan-Meier method. Annual total health-care and CD-related costs were estimated and adjusted for inflation to 2005 US dollars. Generalized linear model was used to assess the impact of loss of response on treatment costs. RESULTS: The study sample included 262 patients with CD with an initial response to infliximab therapy. Within 24 months of therapy initiation, 77% of patients lost treatment response. Upward dose adjustment, a new drug therapy for CD, and CD-related emergency room or inpatient visits were the three most common indicators of loss of response. Both annual total and CD-related health-care costs for patients who lost treatment response during the first year were found to be approximately one-third higher than for those who did not lose response. CONCLUSIONS: The majority of patients who had initial responses to infliximab maintenance treatment subsequently lost response within 2 years. Loss of response was associated with a significant increase in total health-care and CD-related costs.

A review of infliximab use in ulcerative colitis.

BACKGROUND: Infliximab is a chimeric immunoglobulin G1kappa monoclonal antibody that binds with high affinity and specificity to the soluble form of tumor necrosis factor (TNF)-alpha, preventing it from binding to cellular receptors. Infliximab also binds to membranebound TNF-alpha found on inflammatory cell surfaces, inducing apoptosis. Currently, infliximab is used for the induction and maintenance of remission in Crohn's disease (CD), with documented success. Infliximab's efficacy in the treatment of ulcerative colitis (UC) is now being investigated due to the similarities in the pathophysiology of CD and UC. OBJECTIVE: The aim of this study was to review and evaluate the current literature of infliximab use in steroid-refractory UC to assess its role in treatment. METHODS: A search of MEDLINE was conducted (1950-November 2007). Key terms included, but were not limited to, infliximab, inflammatory bowel disease, ulcerative colitis, cost, and quality of life. Studies included for review were limited to English-language, full-text, randomized, double-blind, placebo-controlled trials. Clinical trials were reviewed and summarized. RESULTS: Four controlled clinical trials of infliximab in the treatment of steroid-refractory UC were found and assessed. In a double-blind, randomized, controlled trial in 43 patients with moderately severe, glucocorticoid-resistant UC, infliximab and placebo were not significantly different with respect to clinical and sigmoidoscopic remission or quality of life 2 and 6 weeks after infliximab treatment. In a multicenter, randomized, double-blind, placebo-controlled study in 45 patients with moderately severe to severe glucocorticoid-resistant UC, infliximab was associated with a significantly reduced need for colectomy compared with placebo (29% vs 67%; P=0.017). The Active Ulcerative Colitis Trials (ACT) 1 and 2 together included 728 patients with moderate to severe glucocorticoid-resistant UC. The primary outcome, the rate of clinical response at 8 weeks, was significantly higher with infliximab compared with placebo (5 mg/kg: ACT 1, 69.4%, ACT 2, 64.5%; 10 mg/kg: ACT 1, 61.5%, ACT 2, 69.2%; placebo: ACT 1, 37.2%;, ACT 2, 29.3%; all, P < 0.001 vs placebo). Based on the data from ACT 1 and 2, infliximab was associated with improved health-related quality-of-life (HRQOL) scores based on the Inflammatory Bowel Disease Questionnaire and the 36-item Short Form Health Survey. CONCLUSIONS: Current data suggest that infliximab is an effective alternative treatment option for patients with moderate to severe UC with an inadequate response to conventional glucocorticoid treatment. Further trials are needed to assess infliximab's impact on the treatment and progression of UC, the HRQL of patients with UC, and the economic impact on the health care system.