Tapering of TNF inhibitors in axial spondyloarthritis in routine care — 2-year clinical and MRI outcomes and predictors of successful tapering

Abstract

Objectives In a 2-year follow-up study of patients with axial spondyloarthritis (axSpA) in clinical remission who tapered tumor necrosis factor inhibitor (TNFi) treatment according to a clinical guideline, we aimed to investigate the proportion who successfully tapered/discontinued therapy and baseline predictors thereof. The proportion regaining clinical remission after flare and the progression on MRI/radiography were also assessed. Methods One-hundred-and-nine patients (78(72%)/31(28%) receiving standard respectively reduced dose) in clinical remission (BASDAI < 40, physician global score < 40) and no signs of disease activity the previous year tapered TNFi as follows: to two-thirds of standard dose at baseline, half at week 16, one-third at week 32 and discontinuation at week 48. Patients experiencing clinical, BASDAI or MRI flare (predefined criteria) stopped tapering and escalated to previous dose. Prediction analyses were performed by multivariable regression. Results One-hundred-and-six patients(97%) completed 2-years follow-up; 55 patients(52%) had successfully tapered: 23(22%) receiving two-thirds, 15(14%) half, 16(15%) one-third dose and 1(1%) discontinued. In patients at standard dose at baseline(n = 78), lower physician global score was the only independent predictor of successful tapering (Odds ratio(OR)=0.79(95% Confidence Interval = 0.64–0.93); p= 0.003). In the entire patient group lower physician global score(OR = 0.86(0.75–0.98); p= 0.017), lower Spondyloarthritis Research Consortium of Canada(SPARCC) Sacroiliac Joint Erosion score(OR = 0.78(0.57–0.98); p= 0.029) and current smoking(OR = 3.28(1.15–10.57); p= 0.026) were independent predictors of successful tapering. At 2-years, 97% of patients were in clinical remission. Minimal changes in imaging findings were observed. Conclusion After two years following a clinical guideline, 52% of patients with axSpA in clinical remission had successfully tapered TNFi, only 1% discontinued. Baseline physician global score was an independent predictor of successful tapering.

Factors associated with discontinuation of biologics in patients with inflammatory arthritis in remission: data from the BIOBADASER registry

“…In the case of AS, data from real-world studies are scarce, and it is more difficult to compare results between them owing to the heterogeneous nature of the disease itself and to the fact that most of the studies include optimization strategies. Even so, data on discontinuation because of remission are in agreement with our results, reporting low percentages: 1% in the DANBIO cohort [ 20 ] and 2% in the PULSAR cohort of American veterans with AS [ 21 ]. Similarly, the few available real-world data on PsA show a very low frequency of discontinuation of bDMARDs on achieving remission, e.g., the real-world study of 3 hospitals in Italy (1.7%) [ 22 ] or the recent study on the DESIR cohort of patients who initiated TNF inhibitors during the first 4 years of follow-up (only 1 of 182 patients) [ 13 ].…”

Predicting successful biologics tapering in patients with inflammatory arthritis: Secondary analyses based on the BIOlogical Dose OPTimisation (BIODOPT) trial

“…biologic dose escalation or glucocorticoids); only few patients need to be switched to another biological drug due to persistent flare. [4][5][6][7]11,12 Recently, the BIODOPT trial evaluated disease activity-guided tapering of biologics to continuation of biologics as usual care among patients with RA, PsA or axSpA in sustained low disease activity (LDA) ≥ 12 months. 14 At 18 months follow-up, statistically significantly more patients in the tapering group had reduced their biologic dose ≥50% compared to the control group.…”

“…The evidence of biologic tapering is strongest in rheumatoid arthritis (RA) as multiple trials have been performed, 4–7 weaker in axial spondyloarthritis (axSpA) where fewer studies have been conducted (axSpA) 6–12 and sparse in psoriatic arthritis (PsA) 7,8,10,13 . Across IA diagnoses, biologic tapering seem to be feasible and safe as a considerable dose reduction or interval prolongation can be achieved without losing the therapeutic response 4–7,9–13 . Moreover, the majority of patients who flare regain stable disease activity with rescue therapy (e.g.…”

“…7,8,10,13 Across IA diagnoses, biologic tapering seem to be feasible and safe as a considerable dose reduction or interval prolongation can be achieved without losing the therapeutic response. [4][5][6][7][9][10][11][12][13] Moreover, the majority of patients who flare regain stable disease activity with rescue therapy (e.g. biologic dose escalation or glucocorticoids); only few patients need to be switched to another biological drug due to persistent flare.…”

“…Moreover, the majority of patients who flare regain stable disease activity with rescue therapy (e.g. biologic dose escalation or glucocorticoids); only few patients need to be switched to another biological drug due to persistent flare 4–7,11,12 …”