ABSTRACT
Objectives. To evaluate humoral responses to three doses of the inactivated SARS-CoV-2 vaccine(CoronaVac) in patients with spondyloarthritis(SpA) and the effect of therapy, compared with a control group(CG). Methods. Prospective cohort of axial SpA/psoriatic arthritis patients and age/sex-balanced CG from the CoronavRheum phase 4 trial(NCT04754698).CoronaVac was given in two doses(28-days interval) with a booster at day 210.Blood samples were collected in the days 0/28(D28)/69(D69) and 240(D240) to evaluate anti-SARS-CoV-2 IgG seropositivity(SP) and neutralising antibodies(NAb). Results. 194 SpA patients were enrolled and 183 patients were age/sex-balanced with 183 CG. At D69, SpA patients showed a high SP(80.2%vs.95.7%,p<0.001) and moderate NAb positivity(61.6%vs.82.7%,p<0.001), but lower than CG. In patients, older age(p=0.038), prednisone(p<0.001), methotrexate(MTX)(p<0.001) and TNF inhibithors (TNFi)(p<0.001) were independently associated with lower SP, while Caucasian ethnicity(p<0.05) and prednisone(p<0.01) were associated with diminished NAb. In contrast, sulfasalazine(SSZ) use was associated with NAb presence(p<0.05). In monotherapy, only TNFi was also associated with absence of SP(p<0.05). Further comparison with CG revealed that TNFi and/or MTX negatively impacted SP/NAb(p<0.05). In contrast, patients under SSZ monotherapy achieved 100% SP(p>0.999) and 83.3% NAb positivity(p>0.999). SSZ+TNFi combination resulted in a similar response than CG[SP(p=0.153) and NAb(p=0.715)]. After third dose(D69-D240), a major increment occurred for SP(81.3% to 93.1%,p<0.001) and NAb(63.2% to 86.1%,p<0.001), but still lower than CG(p<0.05), and only TNFi impaired both SP(p=0.016)/NAb(p=0.002). Conclusions. We provided novel data demonstrating that TNFi attenuates immunogenicity in SpA patients while SSZ has a positive impact on vaccine antibody production. We also confirmed that MTX in combination with TNFi had a major negative impact in vaccine humoral response.(CoronavRheum clinicaltrials.gov #NCT04754698)