POS0095 SAFETY AND OUTCOMES OF BIOLOGICAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS IN PATIENTS UNDERGOING DIALYSIS: A LARGE-SCALE RETROSPECTIVE ANALYSIS

Abstract

Background:

The use of biological disease-modifying antirheumatic drugs (bDMARDs) in patients requiring dialysis represents a significant clinical challenge. While discontinuation of biological therapy is usually considered when initiating dialysis, there is limited evidence supporting this approach.

Objectives:

To assess the safety of using bDMARDs concurrently with dialysis.

Methods:

This was a retrospective, nationwide data study analyzing the Clalit Health Care (CHS) database (2005-2024) which insures nearly half of Israel's population. We extracted data to identify patients who received both biological therapy and dialysis. Biologic treatments were defined as bDMARDs or tsDMARDs and are here defined as bDMARDs in general. ARDs were extracted using ICD-9 code hierarchy definitions. For data analysis, we included patients with documented concomitant treatment of bDMARD's and Dialysis. We excluded short-term dialysis (<8 days) and cancer-related biological treatments. We then selected patients who continued biological therapy after dialysis initiation (Bio->Dialysis) or first started bDMARDs after being on dialysis already (Dialysis->Bio and compared them to those who discontinued bDMARDs before dialysis (Bio|Dialysis). Primary outcomes included: treatment overlap duration, mortality rate, and time-to-event analysis for first relevant hospital admission within a year from overlap treatment start. This study was approved by the CHS data collection ethics committee as well as the local medical center Helsinki ethics committee.

Results:

Among 306 patients identified, we defined 78 patients in the Bio->Dialysis group, 57 patients in the Dialysis->Bio group, and 92 patients in the Bio|Dialysis group. For the rest of the analysis here we decided to compare the Bio->Dialysis group to the Bio|Dialysis group. The Bio->Dialysis group had a mean age of 65.0±15.1 years, with a balanced gender distribution (51.3% female). While the Bio|Dialysis group had a mean age of 71.4±13.8 years with 52.2% females. The primary indications for biological therapy in this group were Rheumatoid Arthritis (25.6%), Inflammatory Bowel Disease (21.8%), and Psoriasis/Psoriatic Arthritis (18.0%). The median duration of concurrent biological therapy and dialysis in the Bio->Dialysis group was 435 days, with 89% maintaining treatment beyond 60 days. In 41 (52.5%) of the cases, the biologic treatment continued for at least a month after dialysis cessation (median 42 days). In contrast to the Bio|Dialysis group, patients who continued biological therapy showed better survival patterns (Bio->Dialysis median: 4172 days, Bio|Dialysis median: 551 days; p<0.001). Among the 28 deaths that occurred in the Bio->Dialysis group, 46% occurred within 60 days after treatment overlap cessation. Further time-to-event analysis for the first relevant admission (vascular, infection, or significant events), demonstrated that maintaining biological therapy was associated with similar event rates compared to those who discontinued treatment. When observing Rituximab use, only 1 patient of the 28 that died in the Bio->Dialysis group received Rituximab, compared to 12 of 50 survivors. While among the Bio|Dialysis group, Rituximab use was associated with higher mortality (24 of 66 deaths were in patients previously on Rituximab).

Conclusion:

Our findings shed some light on the frequencies of bDMARD use in dialysis. First, we found a relatively long period of concomitant bDMARD and dialysis use among the Bio->Dialysis group. This is a reassuring finding supporting tough decision for this treatment strategy. Moreover, we found that maintaining bDMARDs in patients through dialysis initiation was coupled with favorable safety signals compared to bDMARD cessation. We found relatively comparable rates of hospital admissions among Bio->Dialysis compared to Bio|Dialysis but lower rates for the Dialysis->Bio group, (Figure 1) suggestting that bDMARDs continuation may be both feasible and beneficial in selected patients. Mortality differences were significant between groups, and especially for Rituximab, which showed favorable survival among Bio->Dialysis compared to Bio|Dialysis ARD patients. This study has limitations, mainly bias by indication and heterogeneity of ARDs and bDMARDs. This should be taken into account when interpreting this data. Yet, these results provide the first large-scale evidence supporting individualized decision-making regarding bDMARDs therapy in dialysis patients rather than universal bDMARDs discontinuation. Table 1. Cohorts characteristics Figure 1a. Time to first putatively ARD-associated admission. b. Survival analysis

REFERENCES:

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Acknowledgements:

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Disclosure of Interests:

None declared. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.