Certolizumab pegol
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Tuberculosis, skin-reaction and Non-Hodgkin’s lymphoma: 3 case reports In a 12-week, open-label, prospective, observational, multicenter, post-marketing study (SONAR; NCT01526434) involving 65 patients, 3 patients [ages and sexes not stated] were described, who developed tuberculosis (1 patient), skin-reaction (1 patient) and Non-Hodgkin’s lymphoma (1 patient) during treatment with certolizumab pegol for rheumatoid arthritis (RA) [routes not stated; not all durations of treatments to reactions onsets stated]. Case 1: The patient, who had RA and had been previously treated with unspecified synthetic disease modifying anti-rheumatic drugs (DMARDs), started receiving treatment with certolizumab pegol 400mg during weeks 0, 2 and 4, followed by 200mg every 2 weeks. The patient had a negative Mantoux test result prior to starting certolizumab. The patient developed active tuberculosis, which was considered to be related to certolizumab by the investigators and certolizumab was permanently discontinued. The positive Mantoux test result was reported 222 days after receiving certolizumab. The patient recovered after treatment with unspecified anti-tuberculosis therapy with the disappearance of pulmonary nodules. Thus, the patient was clinically diagnosed with tuberculosis in spite of absence of microbiological confirmation. Case 2: The patient, who had RA and had been previously treated with unspecified DMARDs, started receiving treatment with certolizumab pegol 400 mg during weeks 0, 2 and 4, followed by 200mg every 2 weeks. Subsequently, the patient developed skin reaction, which was considered to be medically important reaction. The patient’s treatment with certolizumab was permanently discontinued. Thereafter, the patient’s skin reaction recovered. Case 3: The patient, who had RA and had been previously treated with unspecified DMARDs, started receiving treatment with certolizumab pegol 400mg during weeks 0, 2 and 4, followed by 200mg every 2 weeks. The patient was diagnosed with severe nonHodgkin’s lymphoma 69 days after starting certolizumab. Thus, the patient’s treatment with certolizumab was permanently discontinued. The patient died of non-Hodgkin’s lymphoma 64 days after its onset. The non-Hodgkin’s lymphoma was conservatively considered as related to study drug. Blanco FJ, et al. Clinical, Patient-Reported, and Ultrasound Outcomes from an Open-Label, 12-week Observational Study of Certolizumab Pegol in Spanish Patients with Rheumatoid Arthritis with or without Prior Anti-TNF Exposure. Reumatologia Clinica 16: 345-352, No. 5, Sep-Oct 2020. Available from: URL: http://doi.org/10.1016/ 803503105 j.reuma.2018.07.009
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Reactions 26 Sep 2020 No. 1823
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