Long-term efficacy and safety of antitumour necrosis factor alpha treatment in rhupus: an open-label study of 15 patients

Abstract

BackgroundThe efficacy of antitumour necrosis factor alpha (anti-TNF-α) treatment is well recognised in rheumatoid arthritis (RA) but remains controversial in systemic lupus erythematosus (SLE). Therefore, the role of anti-TNF-α treatment in ‘Rhupus’, a disease sharing features of RA and SLE, is still debated.ObjectiveTo evaluate the efficacy and tolerance of anti-TNF-α in patients with rhupus.MethodsFifteen patients with rhupus with Disease Activity Score 28 (DAS 28) >3.2 despite conventional disease-modifying anti-rheumatic drugs were included in an open-label study. Patients were monitored at months (M) 3, 6, 12, 24 and 60 with SLE Disease Activity Index (SLEDAI) and DAS 28. Statistical analyses were performed using Bayesian methods and Prob >97.5% was considered significant.ResultsTwelve patients were treated with etanercept for a median duration of 62.5 (range: 6–112) months and three patients by adalimumab during 36.0 (range: 4–52) months. At baseline, median DAS 28 and SLEDAI were 5.94 (4.83–8.09) and 6 (4–8), respectively. DAS 28 and SLEDAI decreased significantly after 3 months, respectively, to 3.70 (1.80–6.42) and 4 (0–6) (Prob >99.9%, for both). These changes persisted at M6, M12, M24 and M60 (Prob >99.9%, for all). Median prednisone dose decreased significantly from 15 (5–35) mg/day to 5 (0–20) mg/day after 6 months and over the follow-up (Prob >99.9%, for all). Tolerance was acceptable, with a severe infection rate of 3.0 per 100 patient-years.ConclusionThis pilot study suggests that anti-TNF-α is effective in patients with rhupus with refractive arthritis and has an acceptable safety profile.

A comparative study on clinical and serological characteristics between patients with rhupus and those with systemic lupus erythematosus and rheumatoid arthritis

“…29,30 An observational study in refractory rhupus patients showed that anti-TNF-α therapy may also reduce disease activity and protect against the progression of structural damage. 31 In our cohort, rhupus patients were treated more frequently with prednisone, methotrexate and rituximab. We postulate that rhupus patients present a high risk of morbidity, not only because of the disease but also because of the disability, co-morbidities and the secondary effects of the treatments.…”

Adalimumab-Induced Rhupus Syndrome in a Female Patient Affected with Anti-Citrullinated Protein Antibody (ACPA)-Positive Rheumatoid Arthritis (RA): A Case Report and Review of Literature

“…Efficacy and safety of anti-TNF-α has rarely been assessed in patients with rhupus. Interestingly, in an open-label study involving 15 patients following anti-TNF-α treatment, the authors observed no lupus flare in the three rhupus patients treated with adalimumab originator [ 27 ]. This was the only study we found in the literature that focused on efficacy and safety of adalimumab in patients affected with rhupus.…”

Need for Greater Attention to Joint Damage in Rhupus Patients: Results from an Ultrasound Study

“…A few studies observed the effect of biologics on rhupus. A recent study demonstrated that TNFi was effective and safe in treating rhupus, with a follow-up period of 112 months [ 20 ]. A pilot study found that Rituximab was a potential option in treating refractory rhupus [ 21 ].…”