Comparison of perioperative parameters and complications observed in the anterior exposure of the lumbar spine by a spine surgeon with and without the assistance of an access surgeon.

BACKGROUND CONTEXT: The anterior approach to the spine is becoming an increasingly important avenue to treat spine conditions. Most of the literature reporting on the exposure uses an access surgeon assisting the spine surgeon to expose and prepare the spine for implant. PURPOSE: To compare perioperative parameters and complications in anterior lumbar spine surgery with the exposure performed either by a spine surgeon or a general surgeon. STUDY DESIGN: A retrospective cohort study comparing perioperative parameters and complications of anterior lumbar spine surgery. METHODS: A retrospective review was completed on 96 consecutive patients who underwent anterior spine surgery between Levels L3 and S1 from 1995 to 2008. Patient and surgery characteristics including demographics, comorbidities, perioperative parameters, and complications were logged. In the first 56 consecutive patients, a general surgeon completed the exposure, with an additional patient who later had the exposure performed by a general surgeon because of extensive prior abdominal surgeries. In the next 39 patients, the orthopedic surgeon completed the exposure. RESULTS: When the operation was performed solely by a spine surgeon, the estimated blood loss, operative time, and hospital stay was 204 mL, 2.80 hours, and 3.5 days, respectively. In the procedures completed with the aid of a general surgeon, it was found that the same parameters were 420 mL, 3.93 hours, and 4.7 days, respectively, and statistically significantly less in the group without the assistance of the general surgeon (p=.0007, p=.0003, and p=.0006, respectively). Fewer complications also were observed in that group (p<.00001). The most common complication was an ileus. Major complications including retrograde ejaculation, iliac vein bleeding, peritoneal rent requiring repair, dyspareunia, or scrotal/penile swelling were only observed in the group with the assistance of the general surgeon. CONCLUSIONS: This study indicated that a spine surgeon can successfully and safely carry out the anterior exposure to the spine without the aid of an access surgeon.

Effectiveness of adalimumab in treating patients with active psoriatic arthritis and predictors of good clinical responses for arthritis, skin and nail lesions.

OBJECTIVES: To evaluate the effectiveness of adalimumab in patients with psoriatic arthritis (PsA) and identify predictors of good clinical response for joint and skin lesions. METHODS: Patients received adalimumab 40 mg every other week in addition to standard therapy in this prospective, 12-week, open-label, uncontrolled study. Four definitions of good clinical response were used: > or =50% improvement in American College of Rheumatology response criteria (ACR50), good response according to European League Against Rheumatism (EULAR) guidelines, a > or =3-grade improvement in Physician Global Assessment of psoriasis (PGA) and a > or =50% improvement in the Nail Psoriasis Severity Index (NAPSI). Response predictors were determined by logistic regression with backward elimination (selection level was 5%). RESULTS: Of 442 patients, 94% completed 12 weeks of treatment. At week 12, 74%, 51% and 32% of the patients had achieved ACR20, 50 and 70, respectively; 87% and 61% experienced moderate and good responses according to EULAR criteria, respectively. The percentage of patients with PGA results of "clear/almost clear" increased from 34% (baseline) to 68%. The mean NAPSI score was reduced by 44%. No new safety signals were detected. A lower Health Assessment Questionnaire Disability Index (HAQ-DI) score, greater pain assessment, male sex and absence of systemic glucocorticoid therapy were strongly associated with achievement of ACR50 and good response according to EULAR criteria. In addition, greater C-reactive protein concentration and polyarthritis predicted ACR50, and non-involvement of large joints predicted a good response according to EULAR criteria. CONCLUSIONS: Adalimumab was effective in patients with PsA. Lower impairment of physical function, greater pain, male sex and no systemic treatment with glucocorticoids were factors that increased the chance of achieving a good clinical response.

Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study.

OBJECTIVE: To evaluate the effect of adalimumab on the frequency of anterior uveitis (AU) flares in patients with active ankylosing spondylitis (AS). METHODS: We determined the history of ophthalmologist-diagnosed AU in 1250 patients with active AS who were enrolled in a multinational, open-label, uncontrolled clinical study of treatment with adalimumab, 40 mg every other week for up to 20 weeks. All AU flares were documented throughout the adalimumab treatment period plus 70 days. We compared the rates of AU flares per 100 patient years (PYs) reported during the year before adalimumab treatment with rates during adalimumab treatment, in total and by patient subgroups. RESULTS: The AU flare rates before adalimumab treatment were 15/100 PYs in all patients (n = 1250), 68.4/100 PYs in 274 patients with a history of AU flares, 176.9/100 PYs in 106 patients with a recent history of AU flares, 192.9/100 PYs in 28 patients with symptomatic AU at baseline and 129.1/100 PYs in 43 patients with a history of chronic uveitis. During adalimumab treatment, the rate of AU flares was reduced by 51% in all patients, by 58% in 274 patients with a history of AU, by 68% in 106 patients with a recent history of AU, by 50% in 28 patients with symptomatic AU at baseline and by 45% in 43 patients with chronic uveitis. AU flares during adalimumab treatment were predominantly mild. Two patients with periods of high AS disease activity had new-onset AU during the treatment period. CONCLUSIONS: Results of this prospective open-label study suggest that adalimumab had a substantial preventive effect on AU flares in patients with active AS, including patients with a recent history of AU flares. Clinical trials: ClinicalTrials.gov Identifier: NCT00478660.

Effectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-antagonist therapy in clinical practice.

OBJECTIVE: To evaluate the effectiveness and safety of adalimumab in patients with rheumatoid arthritis (RA) who previously discontinued tumour necrosis factor (TNF) antagonists for any reason in clinical practice. METHODS: ReAct (Research in Active Rheumatoid Arthritis) was a large, open-label trial that enrolled adults with active RA who had previously been treated with traditional disease-modifying anti-rheumatic drugs or biological response modifiers. Patients self-administered adalimumab 40 mg subcutaneously every other week for 12 weeks and were allowed to enter an optional long-term extension phase. Measures of adalimumab effectiveness included American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria, Disease Activity Score 28 (DAS28) and the Health Assessment Questionnaire Disability Index (HAQ DI). RESULTS: Of 6610 patients, 899 had a history of etanercept and/or infliximab therapy; these patients experienced substantial clinical benefit from adalimumab treatment. At week 12, 60% of patients had an ACR20 and 33% had an ACR50 response; 76% had a moderate and 23% had a good EULAR response. In addition, 12% achieved a DAS28 < 2.6, indicating clinical remission, and 13% achieved a HAQ DI score <0.5. The allergic adverse event rate, regardless of relationship to adalimumab, was 6.5/100-patient-years (PYs) in previously TNF-antagonist-exposed patients and 4.3/100-PYs in TNF-antagonist-naive patients. A multiple regression analysis indicated no statistically significantly increased risk of serious infections in patients who received prior TNF antagonists compared with TNF-antagonist-naive patients. CONCLUSION: In typical clinical practice, adalimumab was effective and well-tolerated in patients with RA previously treated with etanercept and/or infliximab.

Cutaneous side-effects in patients with rheumatic diseases during application of tumour necrosis factor-alpha antagonists.

BACKGROUND: Patients with rheumatic diseases receiving antitumour necrosis factor (TNF)-alpha-based treatment may develop cutaneous reactions. OBJECTIVES: To analyse the new onset or aggravation of skin lesions in patients with a rheumatic disease during treatment with TNF-alpha antagonists. METHODS: We conducted a prospective analysis of 35 of 150 patients with a long history of rheumatic disease, including rheumatoid arthritis, ankylosing spondylitis (Bechterew's disease) and psoriatic arthritis, to test for the development of cutaneous manifestations during anti-TNF-alpha (infliximab, adalimumab or etanercept) treatment. RESULTS: Chronic inflammatory skin diseases such as psoriasis and eczema-like manifestations represented the majority of cases (16 of 35). Cutaneous infections caused by viral, bacterial and fungal agents were also observed in many patients (13 of 35). Skin diseases such as dermatitis herpetiformis, leucocytoclastic vasculitis and alopecia occurred in single cases only. CONCLUSIONS: We observed a broad, diverse clinical spectrum with a majority of chronic inflammatory and infectious skin diseases. However, we did not identify individual risk factors and a discontinuation of the anti-TNF-alpha treatment was not necessary if adequate dermatological treatment was performed. The onset of cutaneous side-effects in anti-TNF-alpha-based treatments should be determined by nationwide registries.

New onset or exacerbation of psoriatic skin lesions in patients with definite rheumatoid arthritis receiving tumour necrosis factor alpha antagonists.

BACKGROUND: Blockage of tumour necrosis factor alpha (TNFalpha) is highly effective in rheumatic diseases, especially in rheumatoid arthritis (RA), ankylosing spondylitis, and psoriatic arthritis. Furthermore, TNFalpha antagonists have also been shown to significantly reduce psoriatic skin lesions. CASE REPORTS: A series of nine patients with RA who were treated with different types of TNFalpha antagonists and who unexpectedly developed either a new onset or an exacerbation of psoriatic skin lesions are reported.

Treatment continuation in patients receiving biological agents or conventional DMARD therapy.

OBJECTIVE: To compare drug continuation rates in patients with rheumatoid arthritis who start on a biological agent and in a control group of patients with a change in disease modifying antirheumatic drug (DMARD) treatment after previous DMARD failure. METHODS: Patients with rheumatoid arthritis enrolled in the German biologics register between May 2001 and September 2003 were included in the study. Data were available for 511 patients treated with etanercept, 343 with infliximab, 70 with anakinra, and 599 controls. Propensity scores were used to select a subsample of patients from the control group who were likely to be treated with biological agents because of their disease severity, as well as comparable infliximab and etanercept cases. RESULTS: Treatment continuation after 12 months was similar for etanercept (68.6% (95% confidence interval, 62% to 75%)) and infliximab (65.4% (58% to 73%)) but lower for anakinra (59% (41% to 77%)). Treatment continuation was more likely for patients on combinations of biological agents and DMARDs than for those on infliximab or etanercept alone. Patients treated with biological agents were more severely ill than those in the control group and had more previous DMARD failures. After adjustment for baseline differences, the continuation rates were higher in patients treated with biological agents than in comparable control patients treated with leflunomide or leflunomide/methotrexate. CONCLUSIONS: Treatment continuation of biological agents in clinical practice is less likely than in randomised clinical trials but more likely than in comparable controls treated with conventional DMARDs.

[Pharmacotherapy of rheumatic diseases in the aged]. / Pharmakotherapie rheumatischer Erkrankungen im Alter.

The optimal drug therapy of inflammatory rheumatic diseases is based on an individual concept of treatment combining several antirheumatic drugs with different modes of acting. In treating older patients this individual concept has to consider special conditions, as these patients often receive further medications due to different indications so that pharmacologic interactions and comorbidity have to be taken into account. Recently, new substances like COX-2-inhibitors, the new disease modifying antirheumatic drug (DMARD) Leflunomide and particularly the cytokine-blockers provide new and highly effective treatment options. The administration of these drugs in elderly patients is discussed.

Anakinra: the first interleukin-1 inhibitor in the treatment of rheumatoid arthritis.

Rheumatoid arthritis is an immunologically mediated inflammation of joints of unknown aetiology and often leads to disability. This inflammatory process may also involve extra-articular connective tissue. New therapeutic approaches have been made by inhibition of proinflammatory cytokines. Interleukin-1 (IL-1) is regarded as one of the most important mediators in the development of synovialitis. In this article, anakinra (Kineret), the first direct antagonist to IL-1, is discussed, in particular the efficacy and safety data from clinical trials. More than 10,000 patients have been treated with anakinra with significant improvement of inflammation and pain; the rate of radiologically visible progressive joint damage was significantly reduced. Among the adverse events, injection site reactions were most frequent, followed by a mild increase in infections. No activation of tuberculosis, as in tumour necrosis factor-alpha antagonist administration, has so far been reported.

[Not Available]. / Therapie der rheumatoiden Arthritis bei Erwachsenen mit Biologika.

Rheumatoid Arthritis is a progressive and systemic inflammatory disorder of unknown etiology that frequently leads to joint destruction accompanied by multi-system extra-articular manifestations. No curative therapy is available today. Compared to usual Disease Modifying Antirheumatic Drugs (DMARDs), biologicals such as tumor necrosis factor (TNF) α- and interleukin (IL) 1-inhibitors appear to offer greater efficacy and safety, especially in refractory cases. This article deals with the new agents infliximab, etanercept, and anakinra as well as with additional newly developed cytokine-inhibitors. In order to control their use and possible unknown long-term effects, a network of international and national committees has been installed. The actual recommendations for the treatment of rheumatoid arthritis with biologicals are presented, and the cost-benefit relation is discussed.

Oral type II collagen treatment in early rheumatoid arthritis. A double-blind, placebo-controlled, randomized trial.

OBJECTIVE: To investigate the efficacy of oral type II collagen in the treatment of early rheumatoid arthritis (RA). METHODS: Ninety patients with RA (disease duration < or = 3 years) were treated for 12 weeks with oral bovine type II collagen at 1 mg/day (n = 30) or 10 mg/day (n = 30) or with placebo (n = 30), in a double-blind randomized study. RESULTS: There were no significant difference between the 3 groups in terms of response to treatment. However, we observed a higher prevalence of responders in the type II collagen-treated groups: 7 responders in the 10-mg type II collagen group and 6 in the 1-mg group, versus 4 in the placebo group. Furthermore, 3 patients in the 10-mg type II collagen group and 1 patient in the 1-mg type II group, but no patients in the placebo group, had very good response. A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy. CONCLUSION: Only a minority of patients responded to treatment with oral type II collagen. These results justify further efforts to identify which patients will have good response to such therapy.