USE of TELEMEDICINE for FOLLOW-UP of LUPUS NEPHRITIS in the COVID-19 OUTBREAK: ONE-YEAR, PRAGMATIC RANDOMISED CONTROLLED TRIAL

ABSTRACT

Background: Patients with systemic lupus erythematosus (SLE) are at increased risk of severe COVID-19 due to the underlying disease, comorbidities and use of immuno-suppressants (IS). An alternative option would be to adopt telemedicine (TM) to maintain medical care while minimizing exposure. Despite being widely adopted during the pandemic, the evidence supporting the use of TM in rheumatology has been limited. Objectives: We primarily aimed to evaluate the effectiveness to maintain disease activity control using TM delivered care compared to conventional in-person follow-up in patients with lupus nephritis (LN). The secondary objectives were to compare the patient reported outcomes, safety and cost-of-illness from the patient's perspective between the 2 modes of health care delivery. Methods: This was a 1-year, single-center, RCT conducted at a regional hospital in Hong Kong. From May 2020, consecutive adult patients with a SLE according to the 2019 EULAR/ACR classifcation criteria followed up at the LN clinic were invited to participate in the study. Participants were randomized 11 to either TM (TM group) or standard FU (SF group). Patients randomized to receive TM FU were scheduled for a video consultation via a commerical software ZOOM. Patients in the SF group received standard in-person outpatient care. SLE disease activity at each consultation was assessed by SLEDAI-2k and physician global assessment (PGA). Results: A total of 144 patients with LN were randomized and 3 patients self-withdrew from the study. The mean age was 44.5±11.4 years and the median time from diagnosis to randomization was 168 months (range 1-528). Most of the patients had class III, IV or V LN (87.2%) and were on prednisolone (89.4%, median dose 5mg daily). Many of them (68.1%) were on IS. While 66.0% of the patients were in lupus low disease activity state (LLDAS), none had disease remission. There were no baseline differences, including demographics, SLEDAI-2k (TM 3.8±2.3, SF 3.2±2.2, p=0.13, PGA (TM 6.2±6.5, SF 4.6±5.9, p=0.13) and SLE damage index (TM 1.1±1.3, SF 0.8±1.1, p=0.10), between the 2 groups. At one year, 80.0% and 80.2% of the patients in the TM group and SF group were in LLDAS or remission respectively. SLE disease activity indices including SLEDAI-2k, PGA, proteinuria amount and serum anti-ds-DNA level remained similar between the 2 groups. Within the study period, 28 (40%) patients in the TM group and 21 (29.6%) patients in the SF group had disease fare (p=0.20). There were no differences in the SF-36, lupusQoL and HADS scores between the 2 groups at the end of the study. The overall patient satisfaction score was higher in the TM group with a signifcantly shorter waiting time before seeing doctors. At the end of the study, 67.9% of the overall participants agreed to (versus 15.0% who did not agree to) use TM as a mode of future FU. The mean indirect costs of illness (HKD26,681 vs HKD12,016, p=0.20) and the out-of-pocket costs for health care services were similar between the 2 groups (TM HKD13,547 vs SF HKD12,297, p=0.83) in one year. The total number of FU was similar (TM 6.0±2.0, SF 5.7±1.7, p=0.40). However, signifcantly more patients in the TM group (29/70, 41.4% vs 4/71, 5.6%;p<0.01) requested change mode of FU. The proportion of patients requiring hospitalization during the study period was also higher in the TM group (TM 23/70, 32.9% vs 11/71, 15.5%;p=0.02). After adjusting for age and pred-nisolone dosage, not being in LLDAS at baseline was the predictor of hospitalization (OR 3.4, 95%CI 1.20-9.65). None of the participants was tested positive for COVID-19. Conclusion: TM FU resulted in similar 1-year disease activity control and better satisfaction in patients with LN compared to standard care. However, a signifcant proportion of patients cared by TM required in-person visits or were hospitalized. The results of the study suggest that TM delivered care could help minimizing exposure to COVID-19, but it needs to be complemented by physical visits, particularly in those with unstable d sease.