Adverse drug reactions reporting: a questionnaire-based study on Egyptian pharmacists' attitudes following an awareness workshop.

RATIONALE, AIMS AND OBJECTIVES: Hospital pharmacists can promote medication safety through spontaneous reporting of adverse drug reactions (ADRs). However, different educational interventions and different factors (socio-demographic and professional) have been implicated to influence the reporting process. The aims of this study were to assess the impact of pharmacovigilance awareness workshop on knowledge of hospital pharmacists; and to identify the main factors and barriers that influence ADRs reporting. METHODS: Two validated self-administered questionnaires were distributed to pharmacists attending an awareness workshop (pre and post); and a telephone survey was completed three months after the workshop. ADR reports (yellow cards) received from participating pharmacists were monitored for six months, and analysed for quality (validity and seriousness) and reporter demographic and professional factors. RESULTS: Two hundred and eighty-one pharmacists (95.25%) and 270 pharmacists (91.52%) completed pre- and post-workshop questionnaires respectively. A comparison of their knowledge of ADRs to report before and after the workshop showed significant difference (Wilcoxon test P < 0.05). Two hundred and four pharmacists (72.6%) completed the follow-up questionnaire, with lack of time, administrative barriers and inability to complete patient details being the most frequent reasons for not reporting. A total of 163 yellow cards were received from 49 pharmacists (17.44%) over 6 months, of which 126 reports (77.3%) were serious ADRs. Demographics of reporting pharmacists showed significance for completion of post-graduate studies, ministry of health hospitals and pharmacist post in hospital. CONCLUSION: Despite pharmacists' adequate knowledge after the workshop, they failed to maintain consistent reporting. Addressing the barriers to reporting and the personal factors influencing the process may be needed.

Drug persistence, effectiveness and safety assessment of anti-TNF therapies in psoriatic arthritis.

INTRODUCTION: Anti-TNF therapies have been introduced for the management of psoriatic arthritis (PsA). There is a need to assess their effectiveness and safety in clinical practice. AREAS COVERED: This review examines the emerging evidence of effectiveness, safety and drug persistence of anti-TNF therapies in PsA. It also assesses their impact on quality of life and physical functioning in patients with PsA, as well as potential predictors associated with changes in these domains. Several studies from different countries have demonstrated the effectiveness of the anti-TNF therapies in the management of PsA. These therapies have also been shown to be safe and well tolerated over a median usage of 3 years when compared to conventional disease modifying antirheumatic drugs. They also improved quality of life and physical functioning of patients suffering from PsA. EXPERT OPINION: Anti-TNF therapies are effective and safe in the management of PsA. Improvements in disease activity have been shown to be associated with improvements in quality of life of PsA patients receiving anti-TNF therapies.

Improvements in quality of life and functional status in patients with psoriatic arthritis receiving anti-tumor necrosis factor therapies.

OBJECTIVE: To evaluate the impact of anti-tumor necrosis factor (anti-TNF) therapies on quality of life (QOL) and functional status in psoriatic arthritis (PsA) patients and study potential predictors for QOL improvements. METHODS: The study was based on a cohort of 596 PsA patients receiving anti-TNF therapies. Changes in functional status and QOL were assessed using the Health Assessment Questionnaire (HAQ) and Short Form 36 (SF-36) questionnaire on a 6-month basis. The Short Form 6D (SF-6D) was calculated as a utility score. Univariate and multivariate linear regression models were developed to examine potential predictors of QOL improvements at 6 months, using a range of demographic, baseline disease-specific, and therapeutic variables. RESULTS: At 6 months, significant improvements in all SF-36 subscale scores were found, with the greatest percentage improvement from baseline related to physical role (113.8%; 95% confidence interval [95% CI] 102.6, 125.0). The percent improvement for the physical component scale was 53.2% (95% CI 44.5, 61.9) at 6 months, whereas that for the mental component scale was 16.9% (95% CI 14.7, 19.2). The mean +/- SD SF-6D score was 0.58 +/- 0.07 at baseline, and this improved to 0.63 +/- 0.06 at 6 months. The median HAQ score at baseline was 1.88 (interquartile range [IQR] 1.38-2.25) for the entire cohort, and this improved to 1.25 (IQR 0.63-1.88) at 6 months. Improvements in Disease Activity Score in 28 joints at 6 months were found to be significantly associated with QOL improvements at the same time point. CONCLUSION: Anti-TNF therapy is associated with improvement in both physical and mental status in PsA patients. These improvements were most substantial in patients who also had improvements in their disease activity.

Efficacy and safety of anti-TNF therapies in psoriatic arthritis: an observational study from the British Society for Rheumatology Biologics Register.

OBJECTIVES: To evaluate the risk-benefit profile of anti-TNF therapies in PsA and to study the predictors of treatment response and disease remission [disease activity score (DAS)-28 < 2.6]. METHODS: The study included PsA patients (n = 596) registered with the British Society for Rheumatology Biologics Register (BSRBR). Response was assessed using the European League against Rheumatism (EULAR) improvement criteria. Univariate and multivariate logistic regression models were developed to examine factors associated with EULAR response and disease remission using a range of covariates. Poisson regression was used to calculate incidence rate ratios (IRRs) for serious adverse events (SAEs) vs seronegative RA controls receiving DMARDs, adjusting for age, sex and baseline co-morbidity. RESULTS: At baseline, the mean (s.d.) DAS-28 was 6.4 (5.6). Of the patients, 70.3% were EULAR responders at 12 months. At 6 months, older patients [adjusted odds ratio (OR) 0.97 per year; 95% CI 0.95, 0.99], females (adjusted OR 0.51; 95% CI 0.34, 0.78) and patients on corticosteroids (adjusted OR 0.45; 95% CI 0.28, 0.72) were less likely to achieve a EULAR response. Over 1776.2 person-years of follow-up (median 3.07 per person), the IRR of SAEs compared with controls was not increased (1.0; 0.8, 1.3) [corrected]. CONCLUSIONS: Anti-TNF therapies have a good response rate in PsA, and have an adverse event profile similar to that seen in a control cohort of patients with seronegative arthritis receiving DMARD therapy.

Persistence with anti-tumour necrosis factor therapies in patients with psoriatic arthritis: observational study from the British Society of Rheumatology Biologics Register.

INTRODUCTION: Anti-TNF therapies represent a breakthrough in the treatment of severe psoriatic arthritis. However, little is known about long-term drug persistence with these treatments in patients with psoriatic arthritis in routine clinical practice. The aim of this study was to assess persistence with first-course and second-course treatment with anti-TNF agents in a prospective cohort of psoriatic arthritis patients and to identify factors associated with and reasons for drug discontinuation. METHODS: A total of 566 patients with psoriatic arthritis were registered with the British Society for Rheumatology Biologics Register (first anti-TNF agent: etanercept, n = 316; infliximab, n = 162; and adalimumab, n = 88). Treating physicians completed 6-monthly follow-up questionnaires detailing changes to anti-TNF therapies. Persistence with treatment was examined using Kaplan-Meier survival analysis. Reasons for withdrawal were classified as due to inefficacy, adverse events or other reasons. Univariate and multivariate Cox proportional hazard models were developed to examine potential predictors of withdrawals due to inefficacy or adverse events, using a range of demographic, baseline disease-specific and therapeutic variables. RESULTS: At baseline, the mean (standard deviation) age of patients was 45.7 (11.1) years, 53% were female and the mean disease duration was 12.4 (8.7) years. Persistence data were available for a mean (standard deviation) follow-up of 2.3 (0.9) person-years. In total, 422 patients had completed at least 12 months of follow-up, 75.5% of whom remained on their first anti-TNF drug while 9.5% discontinued due to inefficacy, 10.0% due to adverse events and 5.0% due to other reasons. During the period of follow-up, 178 patients received a second anti-TNF therapy. The survivor function on second anti-TNF for switchers was 74% at 12 months. CONCLUSIONS: Psoriatic arthritis patients show high persistence rates with both initial and second anti-TNF therapies.

Risks and benefits of tumor necrosis factor-alpha inhibitors in the management of psoriatic arthritis: systematic review and metaanalysis of randomized controlled trials.

OBJECTIVE: To evaluate the efficacy and safety of tumor necrosis factor-alpha (TNF-alpha) inhibitors in the management of psoriatic arthritis (PsA). METHODS: We searched electronic databases to identify randomized controlled trials (RCT) of adalimumab, etanercept, and infliximab used in patients with PsA. Random effects metaanalysis was undertaken to produce pooled estimates of the relative risk, risk difference, or the weighted mean difference for efficacy and safety outcomes using Stata version 9.0. RESULTS: Six RCT met the inclusion criteria, including 982 patients. All 3 TNF-alpha inhibitors were significantly more effective than placebo on the basis of Psoriatic Arthritis Response Criteria (PsARC) and American College of Rheumatology response criteria ACR20, ACR50, and ACR70 ratings. There were no significant differences between TNF-alpha inhibitors and placebo in the proportions of patients experiencing withdrawal for any reason (RR 0.48, 95% CI 0.20-1.18), or withdrawal due to adverse events (RR 2.14, 95% CI 0.73-6.27), serious adverse events (RR 0.98, 95% CI 0.55-1.77), or upper respiratory tract infections (RR 0.91, 95% CI 0.65-1.28). Pooled rates for injection site reactions were significantly higher for adalimumab and etanercept than for placebo (RR 2.48, 95% CI 1.16-5.29), but there was no significant difference in the proportion of patients experiencing infusion reactions with infliximab (RR 1.03, 95% CI 0.48-2.20) compared against placebo. Indirect analysis did not demonstrate any significant differences between the TNF-alpha inhibitors. CONCLUSION: TNF-alpha inhibitors are effective treatments for PsA with no important added risks associated with their short-term use. There is still a need for longterm risk-benefit assessment of using these drugs for the management of PsA.