Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice

Abstract

Methods: Observational, open-label multicenter study from 40 national referral centers of GCA patients treated with TCZ due to inefficacy or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants, glucocorticoid-sparing effect, prolonged remission and relapses. A comparative study was performed: a) TCZ route (SC vs. IV); b) GCA duration (≤6 vs. >6 months); c) serious infections (with or without); d) ≤15 vs. >15 mg/day at TCZ onset. Results: 134 patients; mean age, 73.0±8.8 years. TCZ was started after a median [IQR] time from GCA diagnosis of 13.5 [5.0-33.5] months. Ninety-eight (73.1%) patients had received immunosuppressive agents. After 1 month of TCZ 93.9% experienced clinical improvement. Reduction of CRP from 1.7 [0.4-3.2] to 0.11 [0.05-0.5] mg/dL (p<0.0001), ESR from 33 [14.5-61] to 6 [2-12] mm/1 st hour (p<0.0001) and decrease in patients with anemia from 16.4% to 3.8% (p<0.0001) were observed. Regardless of administration route or disease duration, clinical improvement leading to remission at 6, 12, 18, 24 months was observed in 55.5%, 70.4%, 69.2% and 90% of patients. Most relevant adverse side-effect was serious infections (10.6/100 patients-year), associated with higher doses of prednisone during the first three months of therapy. Conclusion: In clinical practice, TCZ yields a rapid and maintained improvement of refractory GCA. Serious infections appear to be higher than in clinical trials.

Recognition and management of respiratory co-infection and secondary bacterial pneumonia in patients with COVID-19

“…The risk of serious bacterial infections has been consistently reported to be higher with tocilizumab use for rheumatological diseases. [33][34][35][36] C-reactive protein (CRP) and other acute phase reactants including white blood cell count may be unreliable acute phase reactants and may not rise in response to a secondary bacterial infection after tocilizumab use. 34,37,38 Exactly how long this effect lasts with 1 or 2 doses is unclear.…”

Apremilast in refractory orogenital ulcers and other manifestations of Behçet's disease. National multicenter study of 51 cases in clinical practice.

“…BD diagnosis was performed according to the International Study Group for BD (ISGBD) criteria reported in 1990 [17]. As indicated by the Spanish National Guidelines for bDMARDs and tsDMARDs in Rheumatology [18][19][20][21][22], infections as well as malignancies were ruled out before starting the treatment. APR was initiated using dose escalation until reaching a maintenance dose of 30 mg twice daily.…”

Riesenzellarteriitis: Aktuelle Erkenntnisse zu Epidemiologie, Pathogenese, Diagnostik und Therapie

“…Auch unter Alltagsbedingungen bewirkt Tocilizumab nach einem Jahr bei ca. 70 % eine Remission [59]. Allerdings zeigten sich bei diesem Patientenkollektiv, welches vor Therapiebeginn oft intensiv vorbehandelt war, mit ca.…”

“…Allerdings zeigten sich bei diesem Patientenkollektiv, welches vor Therapiebeginn oft intensiv vorbehandelt war, mit ca. 10 Infektionen auf 100 Patientenjahre eine vergleichsweise hohe Infektionsrate [59]. Die Therapie mit Tocilizumab führt nur bei einem Drittel der Patienten zum Rückgang der im MRT nachweisbaren Wandentzündung [60].…”