Background Rituximab, a chimeric monoclonal anti-CD20 antibody, is approved to be infused over 4hours and 15minutes, due to the potential for infusion reactions. The risk of infusion reactions has been shown to be greatest with the first infusion. Previously we reported our experience with rapid rituximab infusion in 10 rheumatoid arthritis patients, receiving a total of 26 rapid infusions. We now report a current safety analysis of 28 patients receiving a total of 132 rapid infusions in a single rheumatology practice. Objectives To evaluate the safety, tolerability, and practicality of a rapid-infusion protocol for rituximab in RA patients (n=28) in a single community setting. Methods Patients, who were prescribed Rituximab for treatment of moderate to severe RA, were recruited from October 2006 to November 2013 and given the opportunity to participate in the rapid infusion protocol. All patients provided written informed consent. Each treatment course consisted of two rituximab 1000mg infusions, give 2 weeks apart. The first infusion followed the conventional infusion schedule. Rapid infusion protocol was administered on second and/or all subsequent infusions over 2hours. All patients received premedication. Vital signs were recorded at baseline and at 15, 30, 60, 90 and 120minutes. Results A total of 57 patients received rituximab infusions (280 infusions) from October 2006 to November 2013. Out of these, 50 patients with a diagnosis of rheumatoid arthritis met the criteria to be followed on the short infusion protocol. A total of 28 patients agreed to be followed on the rapid rituximab infusions. 132 infusions were included in this analysis with the mean treatment interval of 9.4 months. 93% of the patient population had failed or were intolerant to prior TNF-α inhibitors and 7% were biologic naïve. A total of 7 infusion reactions were reported over 132 rapid rituximab infusions (28 patients), as compared to 8 infusion reactions over 148 conventional infusions (22 patients). There was no significant difference in the incidence of infusion reactions between rapid and conventional infusion (p=0.97). In both rapid and conventional infusions, no patients discontinued rituximab due to infusion-related symptoms and reactions. Overall, all symptoms reported were mild and resolved within 24 hours after the infusion. No serious infections or serious adverse events were reported in both short and conventional infusion groups. Conclusions The current analysis provides reassurance that rapid rituximab infusion is safe and well tolerated. Our experience of administering this protocol over seven years proves that rapid infusion is as safe as the conventional infusion. In addition to safety, patients reported greater satisfaction with the short infusion duration. These data and previously reported data on rapid infusion in rheumatoid arthritis patients assure physicians that this strategy can be safely implemented in an infusion clinic setting. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-e...
Temporomandibular joint ankylosis is the most common cause of facial deformity.1-4The main etiology of TMJ ankylosis include trauma and infection3,5.TraditionallyTemporomandibular joint Ankylosis patients had been managed with different treatment options including Gap arthoplasty6,Interpositiongap arthroplasty ,distraction osteogenesis and total joint replacement.To prevent reankylosis interposition of fascia or muscle had been documented and if reconstruction of the joint was needed Alloplastic(sialistic)or Autogenous graft ( Costochondral bone graft) had been used.6, 7,8,9 Costochondral graft is preferred for reconstruction because morphological it is similar to the condyle of mandibleandhas agrowth capacity.9But thisgraft is unpredictable in nature and different results are reported and documented including facial asymmetry, over growth, graft resorption, graft failure and even reankylosis.9 Distraction osteogenesis is a recent treatment method for the correction of hypo plastic mandible in Temporomandibular joint ankylosis patients. By using distraction osteogenesislarge skeletal movements are possible with little or no relapse commonly seen in other orthognathic corrections. In this study of 30 patients all patients were treated with TMJ Interposition gap arthoplasty (interposition of temporalis fascia) followed by the application of distractors at ramus of mandible. Mean age was14.96±4.17 years. Patient’s minimum and maximum age was 8 and 24 years respectively. Gender distribution shows that 15(50%) of the patients were male and 15(50%) were females. Male to female ratio was 1:1.Mean ramus length before distraction was 38.70±7.28 mm with 28-52 mm range. Mean ramus length after distraction osteogenesis was 49.00±8.01 mm. Mean increase in vertical ramus length was 10.26±2.86 mm. Minimum increase was 5mm and maximum increase in vertical ramus length was 15 mm respectively. In this study we were able to achieve increase in ramus length in all patient and only patient require reoperation due to failure of distractor appliance which was replaced successfully.
Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient died of sepsis caused by decubitus ulcer infection. DAS28-CRP score was decreased from 3.9 to 2.7 significantly. Although CRP was decreased from 1.50 to 0.93 mg/dl, it wasn't significant. Matrix metalloproteinase (MMP)-3 was decreased from 220.0 to 174.2 ng/ml significantly. Glutamate pyruvate transaminase (GPT) was increased from 19 to 35 U/l and number of leukocyte was decreased from 7832 to 6271 significantly. DAS28-CRP, CRP, and MMP-3 were improved significantly with MTX, although they weren't without MTX. Increase of GPT and leukopenia were seen significantly with MTX, although they weren't without MTX. Conclusions: It was reported that the risks of IP caused by LEF in Japanese RA patients were past IP history, loading dose administration and low BW. Addition of low-dose LEF is a potent safe alternative for the patients showing unsatisfactory response to current medicines, but need to pay attention for liver function and infection caused by leukopenia, especially with MTX. Disclosure statement: The authors have declared no conflicts of interest. Bac...
Background: Oral Lichen Planus (OLP) is a relatively common chronic inflammatory mucocutaneous disorder. WHO considers OLP a premalignant lesion. This makes management of OLP important to avoid its malignant transformation. Corticosteroids are considered as the first-line of treatment. Different other treatment modalities are also in use for OLP. But there is no statistically significant data available for a particular therapy. The recent evidences suggest methotrexate may effectively be used in low dose in the treatment of OLP. Aim: To compare the frequency of complete resolution of mucosal lesions of oral lichen planus with low dose oral methotrexate versus systemic corticosteroids. Methods: It was a randomized control trial conducted at Oral & Maxillofacial Surgery Department, King Edward Medical University/Mayo Hospital Lahore in six months. A sample of 60 patients was divided into two sub groups namely Group -A (methotrexate) and Group - B (corticosteroid) using lottery method. More than 75% resolution of mucosal lesions clinically was considered as complete resolution at the end of 8th week. Results: The mean age of the patients was 44.55±12.38 years. On 8th week, frequency of complete resolution of mucosal lesions was 73.3% in Group A and 60% in Group B with an insignificant difference (p-value<0.05). Conclusion: Methotrexate group A showed more complete resolution of mucosal lesions than corticosteroid group B with insignificant statistical difference. Keywords: Oral Lichen Planus, Mucosal lesions, Malignant transformation, Methotrexate, Corticosteroids
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