Background/Purpose: Remission is considered an achievable goal for many patients under biologic therapies. However, currently there is limited information about predictors of discontinuation of biologic therapy in patients with RA. Our aim was to conduct a cohort study of patients enrolled in a National Registry of Biologic therapies to clarify how often biologic DMARD are discontinued due to remission and to identify predictors of discontinuation according to baseline characteristics at the time of initiation of biologic treatment.

Methods:  We conducted a retrospective, observational cohort study of previously collected data from one national registry.   We included RA patients who had at least 3 consecutive months on the same first biologic DMARD. Patients receiving rituximab were excluded. The index date was defined as visit when biologic therapy was started. The study period included patients recorded in the registry from April 1998 until December 2013. The endpoint of interest was defined as discontinuation of biologic DMARD due to remission defined by treating physician. Censoring occurred administratively (end of registry data), when patients stopped the treatment for other causes (side effects, lack of efficacy or pregnancy among others) or by loss to follow up. We used multivariable proportional sub-distribution hazards (SHR) models to examine the association between several predictors with discontinuation due to remission with loss to follow-up, discontinuation due to lack of efficacy, side effects or other causes as competing events.

Results:  The study included 3,516 patients with diagnosis of RA and of these 3,161 patients having received at least 3 months of biologic DMARD.  753 patients stopped treatment due to side effects, 867 patients discontinued treatment due to lack of efficacy, 101 were loss of follow-up, 143 for other reasons, 48 patients for pregnancy. In 15 cases the cause of discontinuation was not established. 1175 patients still receiving biological DMARD until the end of the study. Only 59 (1.8%) patients were able to discontinue biologic therapy due to remission. Baseline characteristics of patients at the moment of starting biologic DMARDs are in Table.  After multivariate SHR analysis, sex (female) (SHR 2.81 95% CI 1.01-7.83), age at onset (SHR 1.04 (95% CI 1.01-1.07) and disease duration (HR 0.94, CI 95% 0.90-0.98) were significant predictors of discontinuation due to remission adjusting by methotrexate and steroids use.  

Conclusion:  A small proportion (<2%) of patients with RA were able to discontinue biologic DMARD therapy due to disease remission. Sex, age at onset and disease duration were predictors of such discontinuation. The prognosis of biologic-free patients after remission is still unknown and further studies are needed to elucidate their clinical course

Table. Baseline characteristics at the moment of starting biologic DMARDs.

	No remission N=3,102	Discontinuation for remission N=59	p value
Mean age (Years,  SD)	53.9 (13.2)	58.5 (12.4)	0.007
Sex (Female %)	79.9	88.1	0.11
Mean disease duration (years, SD)	9.3 (8.7)	7.0 (6.0)	0.04
Seropositive RA (%)	89.3	89.8	0.89
Current smoking	12.2	6.8	0.20
Extra-articular disease (%)	20.1	15.3	0.35
Nodular disease (%)	7.4	5.1	0.25
Mean DAS-28 (SD)	3.75 (2.85)	4.22 (2.47)	0.21
Methotrexate (ever, %)	56.7	62.7	0.35
Steroids use (at index date, %)	53.4	59.3	0.37
DMARDs use (at index date, %)	71.2	71.2	0.99
Anti-TNF therapy (as first treatment, %)	93.9	98.3	0.15

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/predictors-of-discontinuation-of-biologic-dmard-therapy-due-to-remission-in-patients-with-rheumatoid-arthritis-in-a-national-registry/