Treat-to-target TNF-inhibitor tapering does not negatively impact PsA, axial SpA activity
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Treat-to-target tapering of TNF inhibitors in patients with psoriatic arthritis or axial spondyloarthritis does not result in any negative impact on disease activity, compared with the full dose, according to data published in Rheumatology.
“Tumor necrosis factor inhibitors (TNFi) have proven safe and effective in the treatment of spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA),” Celia A. J. Michielsens, a PhD student at Sint Maartenskliniek Nijmegen, in the Netherlands, and colleagues wrote. “However, these drugs also have disadvantages such as an increased risk of infections, injection site reactions and the self-administration burden for patients, and high costs. Disease activity-guided dose optimization (DAGDO) until complete withdrawal or flare could be a way to reduce these disadvantages.”
“However, there is still uncertainty concerning the effects of DAGDO and discontinuation of TNFi in PsA and axSpA patients with stable low disease activity (LDA) on long-term disease control and safety,” they added. “Since 2010, a specific TNFi DAGDO protocol has been implemented at our outpatient clinic for RA as well as for PsA and axSpA patients, together with standardized measurement of Disease Activity Score28-C-Reactive Protein (DAS28-CRP) in RA, and PsA patients and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in axSpA patients.”
To examine the impacts of DAGDO regarding TNF inhibitors among patients with PsA and axial SpA with low disease activity, Michielsens and colleagues conducted a retrospective cohort study at their own clinic. Participants included 324 patients aged 16 years or older with either disease and treated with adalimumab (Humira, AbbVie), etanercept (Enbrel, Amgen), certolizumab pegol (Cimzia, UCB), golimumab (Simponi, Janssen) or infliximab (Remicade, Janssen) between April 2012 and October 2018. Among the participants, 153 had PsA and 171 had axial SpA.
The researchers analyzed three defined treatment periods — the full-dose continuation period, the TNF-inhibitor DAGDO period and the period with stable TNF inhibitors following DAGDO. Michielsens and colleagues used a mixed-model analysis to examine the mean DAS28-joint count CRP (DAS28-CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for all three periods. They also calculated the mean percentage of the daily defined dose as a secondary outcome. Mean follow-up duration was 46 months for patients with PsA and 44 months for those with axial SpA.
According to the researchers, there was a corrected mean DAS28-CRP difference of 0.06 (95% CI, –0.09 to 0.21) during the TNF-inhibitor DAGDO period, and 0.03 (95% CI, –0.14 to 0.20) for the period with stable TNF-inhibitor dose, compared with the full-dose continuation period. Meanwhile, differences in BASDAI were 0.03 (95% CI, –0.21 to 0.27) and 0.05 (95% CI, –0.24 to 0.34), respectively. The mean percentages of the daily defined dose for the three treatment periods were 108%, 62% and 78%, respectively, for PsA, and 108%, 62% and 72%, respectively, for axial SpA.
“This large and long-term retrospective cohort study indicates that DAGDO — in line with results in RA — is also effective and safe in PsA and axSpA patients who are doing well on their TNFi,” Michielsens and colleagues wrote. “This strategy resulted in lower doses of TNFi being used with no significant difference in disease activity score for both PsA and axSpA between the three treatment periods. Our study suggests that DAGDO is effective and safe in PsA as well as axSpA. However, in light of the limitations, more definite evidence should be provided by well-designed randomized prospective studies."
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