Objectives A significant proportion of Rheumatoid arthritis patients, particularly when associated with poor prognostic factors, fail on cDMARDs. Although Rituximab (RTX) has been effective in these patients, cost of therapy makes it unaffordable, particularly in poor and developing countries. Numerous, albeit small studies, using lower doses have shown contradictory results. We aimed to analyze effectiveness of low dose RTX protocol based on clinical outcomes in RA patients. Methods Seropositive RA patients with moderate-high disease activity (DAS28-ESR > 3.2) despite combination cDMARDs, treated with RTX, were included in retrospective analysis. All patients were treated as per predefined protocol using 500 mg RTX with ongoing cDMARDs at baseline and repeat dosing at six weeks or beyond on lack of moderate-good EULAR response. Assessment of B cell count was done at baseline, two and 24 weeks. Results At 12 weeks, 93% of 166 patients (mean age, M: F and disease duration, 51.5 ± 11.96 years, 25:141 and 10.4 ± 6.29 years respectively), achieved moderate-good EULAR response. At 24 weeks, 90.8%, 19.8% and 29.5% patients achieved moderate-good EULAR response, low disease activity and remission, with a mean change in DAS28-ESR from baseline by 2.9 ± 1.3. RTX failure and relapse were seen in 5.4% and 3.6%, respectively. Response was maintained for 12.3 ± 7.2 months with a mean RTX dose 521.1 ± 100.8 mg. Adverse events were seen in 9.6%. When compared with standard dosing regimen with originator molecule, 90% cost reduction was achieved. Conclusion Low dose RTX regimen achieved reasonably good clinical outcomes at end of six months with a significantly lower cost.
BackgroundPalindromic rheumatism (PR) although often considered as a benign disease can be severe and resistant to DMARDs in some patients. In these patients it can result in almost daily attacks, migrating from joint to joint resulting in poor quality of life. Rituximab has been proven to be effective in treatment of seropositive RA.ObjectivesTo determine the efficacy and safety of Rituximab in patients with seropositive PR who had an inadequate response to CsDMARDsMethodsPR was diagnosed based on criteria proposed by Hannonen P et al. Seropositive (ACPA±RF positivity) PR patients who had active disease despite being treated with two Cs DMARDs for >3 months, were treated with Rituximab. Active disease was defined as >4 attacks per month requiring intake of NSAIDS. All the patients were started on 500mg of rituximab after baseline work up. If complete control of palindromic attacks was not achieved and B cells were detectable in the peripheral blood by flow cytometry another 500 mg infusion was given after 2 weeks. Patients were continued on maximum tolerable dose of DMARDS. Patients were given repeat infusion of Rituximab once the patient developed clinical relapses as evidenced by recurrence of palindromic attacks.ResultsTwenty three patients with a mean age of 44.60±13.51 yrs and mean disease duration of 5.47±3.25 yrs were included. All patients were positive for ACPA while 17 patients were positive for RF. These patients were on a background of minimum of 2 DMARDs. Despite the maximum tolerable dose of DMARDs they had mean attack rate of 5.30±2.38 attacks per month. During a mean follow up of 14.17±8.62 months seven patients required two infusions and three patients required three infusions. Of the 33 infusions 500 mg was effective in controlling the attacks majority (88%) of the times. Seven patients required another 500 mg infusion after 2 weeks as initial 500 mg dose failed to achieve complete control of disease and B cell were not depleted in the peripheral blood. At one month follow up all patients achieved complete control of disease. Remission lasted for 10.33±5.75 months. When symptoms recurred patients were treated with rituximab again and all regained complete control of the symptoms. None of the patients evolved into RA during the study period. No serious adverse events were observed. Five patients experienced minor allergic reactions during infusion which were managed according to the standard protocol.ConclusionsThis case series indicates in patients of PR resistant to Cs DMARDs rituximab not only achieves disease control but also prevents progression to RA. To best of our knowledge this is the first report regarding efficacy of rituximab in PR. Although it needs to be proved in a larger blinded RCT this early data indicates that Rituximab may be a therapeutic option to prevent development of RA in seropositive patients.References Hannonen P, Möttönen T, Oka M. Palindromic rheumatism. A clinical surveyof sixty patients. Scand J Rheumatol. 1987;16(6):413–420.Sanmarti R, Cañete JD, Salvador G. Palin...
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