The period between the last rituximab infusion and the first dose of the new biologic varied from 1 to 12?months among patients who experienced an adverse event

The period between the last rituximab infusion and the first dose of the new biologic varied from 1 to 12?months among patients who experienced an adverse event. from 1 to 12?months among patients who experienced an adverse event. Among the five patients who began treatment with a biologic within 1?month of their last rituximab infusion, only one patient developed an infection (a mild urinary tract infection). Table?2 Adverse events reported after starting a new biologic therapy thead th align=”left” rowspan=”1″ colspan=”1″ Adverse event /th th align=”left” rowspan=”1″ colspan=”1″ Biologic therapy /th th align=”left” rowspan=”1″ colspan=”1″ Duration of biologic therapy before onset of adverse event (months) /th th align=”left” rowspan=”1″ colspan=”1″ No. of rituximab courses received /th th LRRK2-IN-1 align=”left” rowspan=”1″ colspan=”1″ Time from last rituximab infusion to first dose of biologic (months) /th th align=”left” rowspan=”1″ colspan=”1″ No. of biologic therapies before rituximab /th /thead Rash (erythema LRRK2-IN-1 nodosum)Etanercept52.5a 41CarbuncleAbatacept9132Urinary tract infectionAdalimumab10.5b 11Upper respiratory tract infectionAbatacept1141Abataceptc 10.5b 123PneumoniaAbataceptc 50.5b 123EczemaInfliximab6131 Open in a separate window aPatient did not receive second infusion of third course bPatient did not receive second infusion of first course cTwo adverse events (upper respiratory tract infection and pneumonia) occurred in the same patient Discussion The results of this retrospective chart review indicate that patients who have an inadequate response to rituximab or who are unable to tolerate rituximab can be restarted safely on a new biologic therapy (TNF inhibitor or abatacept). To date, no serious adverse events requiring hospitalization have been recorded among 22 patients who were treated with etanercept, adalimumab, infliximab, or abatacept following one, two or three courses of rituximab therapy. There was no clear pattern to the type of nonserious adverse events (five infections and two dermatologic events) recorded during biologic therapy post-rituximab. These types of adverse events are typically observed in patients receiving TNF inhibitors [9, 10] or abatacept [11]. Occurrence of an adverse Rabbit Polyclonal to Galectin 3 event appeared unrelated to the number of prior rituximab courses received or to the interval between stopping rituximab and starting the new therapy. Indeed, there was only one mild contamination among the five patients who started a new biologic 1?month after stopping rituximab. Similarly, the type and duration of new therapy did not appear to predict the occurrence of an adverse event. Overall, although the patient numbers are small, there is no evidence from this review of any increase in the incidence of nonserious or serious adverse events in patients who are treated with a biologic agent following a period of rituximab therapy compared with the incidence during rituximab treatment. This obtaining is consistent with long-term follow-up data from the rituximab clinical trial program: a recent analysis, involving 185 patients who received rituximab plus methotrexate and who subsequently received another biologic agent, with follow-up for at least 48?months, showed that 13 serious infections occurred during rituximab therapy (6.99 events/100?patient years), compared with 10 serious infections after initiation of a new biologic (5.49 events/100 patient years) [12]. The infections were reported to be variable and common for patients with RA; no opportunistic or fatal contamination occurred. Our study is limited by a number of factors, including: the small size of LRRK2-IN-1 the patient cohort; the use of a single sampling center; the retrospective nature of the analysis; and the relatively short follow-up period. Nonetheless, the results provide supportive evidence from real-life practice that biologic brokers can be safely given to patients who have discontinued therapy with rituximab. Further results from the clinical trial program extension studies and from national registries and other postmarketing surveillance will be required before firm conclusions can be drawn regarding the safety of biologic therapies after rituximab. Acknowledgments Support for third-party writing assistance for this manuscript, furnished by Neil Anderson, was provided by Genentech, Inc. and Biogen Idec..