Rituximab can be an effective treatment option for patients who have refractory lupus with severe or life-threatening disease with an acceptable tolerance profile.
BackgroundSystemic autoimmune diseases (SAD) have traditionally been treated with steroids and immunosuppressants, but not all patients respond to this strategy. Rituximab (RTX) has been used in several SAD with favorable efficacy and safety results; there are only reports of isolated clinical experiences of small series of patients. The description of this drug safety data in daily clinical practice may be relevant.ObjectivesTo describe the adverse events and the hospital admissions during the treatment of a series of patients with SAD with RTX.MethodsDemographic data, related to disease and treatment, response and safety variables were included. We use the EULAR definitions of partial response (improvement of at least 50% of the main manifestations) and complete response (disappearance of the manifestations), because of the heterogeneity of the SAD.ResultsWe included 53 patients, 90.6% were women; the mean age at diagnosis was 31.42±14.33 years; and the median duration of disease at the onset of RTX 1.99 (0–7.5) years. Patients received a median of 2 cycles (1–3; min -1, max 12); and the median interval between cycles was 14.81 months (6–15.75;min 6, max 120).The SAD were SLE with 23 cases (43.4%), systemic sclerosis with 7 cases (13.2%), Sjögren's syndrome with 6 cases (11.3%), vasculitis with 5 cases (9.4%), Still disease with 3 cases (5.7%), autoinmune cytopenias with 3 cases (5.7%), dermatomyositis with 2 cases (3.8%), Behçet's disease with 2 cases (3.8%), IgG4 disease with 1 case (1.9%) and sarcoidosis with 1 case (1.9%).A partial response was observed in 27 patients (50.9%) and complete in 20 patients (37.7%). There was no response in 6 of the 53 patients (11.3%).Adverse events were detected in 15 of the 53 patients (28.3%) and 20 were hospitalized (37.7%) during the treatment with RTX (Table 1).Infecctions (9)Disease activity (8)Others (3) Respiratory: 7LES: 8Acute coronary syndrome: 1Pyelonephritis: 1Vertebral fracture: 1Stomach flu: 1Metrorrhagia: 1Three patients developed hypogammaglobulinemia, only one of them was associated with recurrent respiratory infections and even hospitalized in one occasion. Febrile neutropenia was detected in 2 patients, and one of them required admission. Three patients were diagnosed with pneumonia and admitted for supportive and antibiotic treatment. Three other patients suffered gastroenteritis requiring admission in one of them. In two cases, low respiratory infections were repeated requiring admission on 7 occasions. There was also recurrent otitis and a severe hypersensitivity reaction.ConclusionsThe most frequent adverse event were the infectious, mainly respiratory tract infections followed by an infusion reaction. No patient developed opportunistic diseases. This findings are similar than observed in other studies on patients with SAD treated with RTX. Infusion reactions are becoming less frequent, due in part to premedication.We are dealing with a large number of patients with refractory EAS treated with RTX, so the data obtained from this study show an acceptabl...
Background and objectives Many autoimmune inflammatory rheumatic diseases have typical cutaneous manifestations, but not always macroscopic skin lesions are characteristic, so it is necessary to perform a skin biopsy to identify a specific pattern that help us to confirm our suspected diagnosis and make a better treatment decision. Materials and methods Descriptive study about 20 patients with skin lesions evaluated in our Rheumatology Unit in the last 18 months, which underwent a skin punch biopsy, as part of the supplementary studies. Results The mean age was 48.9 years ± 20.25 and 90% were women. Only 4 of the 20 patients (20%) had autoimmune diseases (3 hypothyroidism and 1 seronegative oligoarthritis); 11 had cardiovascular risk factors (3 arterial hypertension, 4 dyslipidemia, 3 had type 2 diabetes and 3 had obesity); and 3 had endocrine disorders (1 microprolactinoma, 1 anorexia nervosa and 1 with secondary hyperparathyroidism). Five patients (25%) had fever, 4 patients (20%) oligoarthritis, 1 patient had pneumonia and 1 patient Raynaud’s phenomenon. The only 2 patients with positive ANA, both women, had inmunoglobulins alterations. One of them presented leukocytoclastic vasculitis (LCV) with hypergammglobulinemia IgA and IgM and positive test for rheumatoid factor (RF), and the other had unspecific cutaneous lesions with hyper-IgA. Another patient had hyper-IgE, related to eosinophilic dermatitis. The results of the biopsies were the following (see the table 1 below): Abstract A5.19 Table 1The pathology findings of the biopsies and the number of people with percentage who present that diagnosis in our serie Pathology diagnosis Frequency Unspecific 7 (35%) Leukocytoclastic vasculitis 4 (20%) Panniculitis 2 (10%) Linfocitary dermatitis 2 (10%) Calciphylaxis 2 (10%) Eosinophilic vasculitis 1 (5%) Eosinophilic dermatitis 1 (5%) Martorell hypertensive ischaemic ulcer 1 (5%) Ninety percent were treated with systemic corticosteroids. One patient received nonsteroidal anti-inflammatory drug (NSAID), 1 alprostadil (hypertensive ulcer), 2 sodium thiosulfate (calciphylaxis) and 2 disease modifying antirheumatic drugs (DMARDs) (mixed panniculitis related to intestinal bypass and LCV complicated by ulcers). Ninety percent had an excelent prognosis and only 2 had a poor response to corticosteroids and required intravenous cyclophosphamide (1 calciphylaxis and the LCV complicated). Conclusions In our opinion, the skin punch biopsy is essential in the rheumatologic clinical practice. This is a very simple and easy procedure with a low rate of complications and, although the results are sometimes unspecific, we can improve the diagnosis if the rheumatologist provides clinical information to the pathologist.
IntroductionHead and neck tumours (TTCC) constitute a heterogeneous group of diseases that affect the otorhinolaryngological sphere. The risk factors such as tobacco and alcohol are also for osteoporosis too. The cancer itself, with the malnutrition suffered after surgical treatment and chemoradiotherapy, represents a potential situation of bone loss with the subsequent appearance of osteoporosis and its complication ‘the fracture’. We do not have data on the frequency of osteoporosis in patients with head and neck tumours.ObjectivesTo evaluate the loss of bone mineral density (BMD) in the lumbar spine during the first year of follow-up after diagnosis in a cohort of patients with head and neck tumours.MethodsObservational, longitudinal and prospective study in a cohort of patients with TTCC at the Virgen de Valme hospital, one year follow-up. Bone mineral density was measured by DXA in the lumbar spine before the start of treatment and once a year. To identify qualitative factors that determine bone loss (<2%/≥2%), contingency tables are performed and the Chi-Square test or the non-asymptotic methods of the Monte Carlo test and the Exacta test are applied.ResultsA total of 50 patients were included. 100% of the patients were male. The average age at diagnosis of 60.9±7.8 years. 98% were smokers, and 76% habitual heavy drinkers. 12% had a family history of hip fracture. 18% have a disease that causes malabsorption syndrome.The median BMD at baseline is 1.05 g/cm2, and after one year of follow-up this median decrease is 1.02. The loss of bone mass in a year expressed in median is estimated at 0.03 g/cm2, which corresponds to a loss of bone mass per year of 2.8%, which reflects a greater loss than that of a population of same age and sex estimated at 0.5–1% per year.Although the loss suffered by our patients is not from a significant statistical point of view, given the sample size, it does reflect a tendency to increase the risk of osteoporosis in these patients.ConclusionsPatients with TTCC suffer a bone loss greater than expected in a population of equal age and sex, in the first year of follow-up. Initial screening of these patients would be indicated, which would include OP and/or fracture risk factors.Reference. Valero C, Olmos JM, Rivera F, Hernandez JL, Vega ME, Gonzalez Macias J. Osteoprotegerin and bone mass in squamous cell head and neck cancer patients. Calcif Tissue Int 2006;78:343–347.Disclosure of interestNone declared
BackgroundSystemic autoimmune diseases (SAD) have traditionally been treated with steroids and immunosuppressants, but not all patients respond to these measures.Rituximab (RTX) has been used in several SAD with favorable results, but there are only a few reports of isolated clinical experiences, with a very small number of patients.Data about use of this drug under conditions of daily clinical practice may be relevant.ObjectivesTo describe the characteristics of patients with SAD who are candidates for treatment with RTX.To evaluate the response to this drug in the different SAD.MethodsDemographic data and disease, treatment and response variables were included.We use the EULAR definitions of partial response (improvement of at least 50% of the main manifestations of the disease) and complete response (disappearance of the manifestations of the disease), because of the heterogeneity of the SAD and their multiple manifestations.ResultsWe included 53 patients, 90.6% were women. The mean age at diagnosis was 31.42±14.33 years; and the median duration of disease at the onset of RTX 1.99 (0–7.5) years. Patients received a median of 2 cycles (1–3 min -1, max 12); and the median interval between cycles was 14.81 months (6–15.75, min 6, max 120).The EAS included SLE with 23 (43.4%) cases, systemic sclerosis with 7 (13.2%) cases, Sjögren's syndrome with 6 (11.3%) cases, vasculitis with 5 (9.4%) cases, Still disease with 3 (5.7%) cases, autoinmune cytopenias with 3 (5.7%) cases, dermatomyositis with 2 (3.8%) cases, Behçet's disease with 2 (3.8%) cases, IgG4 disease with 1 (1.9%) case and sarcoidosis with 1 case (1.9%).A partial response was observed in 27 patients (50.9%) and complete in 20 patients (37.7%). There was no response in 6 of the 53 patients (11.3%). The response by disease groups is detailed in Table 1.SADPartial responseComplete responseNo response SLE (n=23)9 (39,1%)12 (52,2%)2 (8,7%)Systemic Sclerosis (n=7)5 (71,4%)2 (28,6%)0Vasculitis (n=5)5 (100%)00Sjögren (n=6)3 (50%)3 (50%)0AI cytopenias (n=3)1 (33,3%)1 (33,3%)1 (33,3%)Dermatomyositis (n=2)1 (50%)1 (50%)0Behçet's disease (n=2)002 (100%)IgG4 related disease (n=1)01 (100%)0Sarcoidosis (n=1)1 (100%)00ConclusionsIn our study, patients treated with RTX achieved response in 88.7%; similar than some experiences of RTX off-label use.Remision of the disease occurs in 50% of the patients.The best results are observed in SLE, especially in lupus nephritis, and Sjögren disease.The results in SS are promising due to the limited therapeutic resources for this disease.References Ramos-Casals M, García-Hernández FJ, de Ramόn E, Callejas JL, Martínez-Berriotxoa A, Pallarés L, et al. Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases. Clinical and experimental rheumatology 2010; 28 (4): 468–76. Disclosure of InterestNone declared
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