SAT0555 LOSS TO FOLLOW-UP IN REGISTRIES OF RHEUMATIC PATIENTS TREATED WITH BIOLOGICS: A POTENTIALLY VALUABLE HIDDEN REAL-WORLD DATA THAT IS BEING OVERLOOKED?
Authors: Ana Valido, Joana Silva-Dinis, Maria João Gonçalves, Vasco Romão, Maria João Saavedra, Joao Eurico Fonseca
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> The information associated with loss to follow-up (LFU) patients (Pts) may affect a real-world data evaluation of the use of biologics (Bio) that is not being adequately captured in registries. <h3>Objectives:</h3> To identify the reasons for LFU in rheumatic patients treated with biologics in our center. <h3>Methods:</h3> We identified all Pts treated with Bio in our center who had no registered visits in Reuma.pt for more than 6 months. We retrieved baseline information from Reuma.pt and from the hospital electronic clinical record. We then performed a telephonic interview to characterize the reasons for LFU up at our day care unit. For Pts unable to be contacted by telephone a letter of invitation to an appointment at the hospital was sent. <h3>Results:</h3> From a total of 790 Pts registered in Reuma.pt at our centre with active Bio therapy (BioTx) 227 did not have any information registered in last 6 months. Of this, 36 Pts were on BioTx prescribed by other Department (Dermatology, GEA) and maintain follow-up in these departments. 102 Pts had suspended BioTx by medical indication, and this information was registered in the hospital electronic clinical records but not updated in Reuma.pt. For 89 Pts (47%) no information could be retrieved from either the hospital electronic clinical record or Reuma.pt and we classified these Pts as true LFU. Reasons of LFU were: being followed in other Rheumatology centres (n=28; 31.4%), death (n=26; 29.2%), adverse effects (AE) (n=11; 12.4%), other (n=5, 5.6%) and clinical remission (n=4; 4.5%). 15 Pts (16.9%) could not reach us by telephone or attend the appointment. 28 of these LFU Pts were being followed up in another Rheumatology center. The most frequent reasons for this change were: 15 (16.9%) decided to move the follow-up to a newly created and closer Rheumatology Department; 6 (6.7%) moved to another city; 5 patients (5.6%) had administrative problems related to our Department/Hospital and 2 (2.3%) patients referred socio-economic reasons that were interfering with travelling. 26 of the LFU Pts died, at a mean age of 66.3 years. The mean disease duration was 14.3 years and 20 Pts (76.9%) had RA. The mean duration of Bio was 5.9 years and 53.8% were under anti-TNF therapy, 16% under Anti-CD20 therapy and 12% under interleukin-6R inhibitors. Cause of death was identified in only 3 patients: 1 had a myocardial infarction, 2 had surgery complications. None of these Pts was on BioTx at the moment of death. 11 Pts of the LFU had stopped BioTx and abandoned follow-up by their own decision after suffering AE attributed by the patient to the use of Bio. 6 patients (6.7%) had infections: cutaneous (n=3, 3.4%) or urinary tract related (n=3, 3.4%); with need of hospital admission in 2 of the cases (2.2%). The remaining Pts stopped the drug because of cutaneous reactions (n=5. 5.62%). 4 Pts of the LFU were in remission and decided to stop the drug and the medical follow up. All of them believed that the disease was inactive without the need of medical drugs. <h3>Conclusion:</h3> Identifying LFU Pts and clarifying the reason for the loss of data in a register contributes to a better knowledge on strategies to discontinue Bio in stable Pts, to a better pharmacovigilance of adverse effects and to more efficiency in data capture by registries. The authors of this study are now making additional efforts to contact the 15 still missing Pts and obtaining access to death certificates in order to further clarify the cause of death of 23 Pts. <h3>Disclosure of Interests:</h3> None declared