Efficacy and Safety of Tocilizumab in Elderly GCA Patients

Table 1. Baseline characteristics of patients with giant-cell arteritis over 80 years old who received tocilizumab
Characteristics	Patients (n = 21)
Demographics
Age	84 [81–90]
Female sex	16 (76)
Past medical history
Number of cardiovascular risk factors (except age and sex)	1 [0–3]
Hypertension	11 (52)
Tobacco use	2 (10)
Diabetes mellitus	4 (19)
Hypercholesterolemia	6 (29)
Overweight	2 (10)
Coronary disease	4 (19)
Previous stroke	2 (10)
Diverticulosis	2 (10)
Osteoporotic fractures	2 (10)
Myelodysplasia	1 (5)
Clinical manifestations
ACR criteria	4 [3–5]
Weight loss	15 (71)
Fever	5 (24)
Headaches	17 (81)
Jaw claudication	12 (57)
Abnormal temporal artery	7 (33)
Scalp tenderness	7 (33)
Ophthalmologic involvement	7 (33)
Polymyalgia rheumatica	9 (43)
Limb claudication	1 (5)
Laboratory parameters
Erythrocyte sedimentation rate, in mm	82 [25–138]
C-reactive protein, in mg/l	90 [16–224]
Hemoglobin level, g/dl	10.3 [9.2–15.1]
Positive histology	11/16 (69)
Large-vessel vasculitis ^a	7/16 (44)
At GCA diagnosis	4/13 (31)
During follow-up	3/3 (100)

Values are numbers (%) or medians [range]. CV, cardiovascular; ACR, American College of Rheumatology; GCA, giant-cell arteritis
^aIn patients who underwent large-vessel imaging

Table 2. Treatment and outcomes of patients with giant-cell arteritis over 80 years old who received tocilizumab
Characteristics	Patients (n = 21)
Total follow-up, in months	20 [3–48]
Antiplatelets	18 (86)
Glucocorticoid use
Initial dose, mg/kg	0.8 [0.6–1.1]
Duration of intake in all patients ^a, in months	14 [2–48]
Number of patients who stopped GCs after TCZ introduction	14 (67)
Delay to stop GCs after TCZ introduction	8 [2–21]
Tocilizumab use
Introduction at GCA diagnosis	6 (29)
Introduction during the FU	15 (71)
Delay of introduction in patients with TCZ introduction at FU	8 [3–37]
First-line immunosuppressant	17 (81)
Second-line immunosuppressant	4 (19)
Number of patients who discontinued TCZ at last FU	11 (52)
Duration of TCZ use in all patients, in months	7 [3–28]
Duration of TCZ in patients who stopped it, in months	8 [3–28]
Number of patients with a control of large-vessel imaging	3
Improvement	2
No improvement	1
Relapses before and after TCZ introduction
Number of patients who relapsed	11 (52)
Total number of relapses	19
Delay of the first relapse, in months	5 [2–19]
Number of relapses before TCZ	15
Under TCZ	2
After TCZ discontinuation	2
Delay of relapse after TCZ discontinuation, in months	1 and 13
Death	4 (19)

Values are numbers (%) or medians [range]. GCs, glucocorticoids; FU, follow-up; TCZ, tocilizumab
^aFrom GC introduction to stop or to the last follow-up visit if GCs are ongoing

Table 3. Adverse events and outcomes observed in patients once TCZ started for GCA
Adverse event	Months after TCZ introduction	Dose of GC at AE time	GC duration (months)	CTCAE grade	Treatment/evolution
Patient 1
Hypercholesterolemia	4	10 mg	4	2	No treatment, stable
Patient 2
Hypercholesterolemia	8	10 mg	8	3	Statin, improvement
Patient 3
Hypercholesterolemia	3	0	–	2	No treatment, stable
Patient 4
Pyelonephritis	5	10 mg	9	3	IV antibiotics-TCZ shifted 1 month later
Thrombopenia	2	15 mg	6	1 (75 G/l)	No treatment, stable
Patient 5
Bronchitis	9	6 mg	13	2	Oral antibiotics, healed
Neutropenia	7	8 mg	11	3 (900/mm³)	No treatment, stable
Hepatic cytolysis	7	8 mg	11	3 (5N)	Reduction TCZ to 4 mg/kg, correction of cytolysis
Patient 6
Septic shock^a	20	0	–	5	Death
Mesenteric infarction^a	20	0	–	5
Patient 7
Hypercholesterolemia	9	0	–	2	No treatment, stable

Values are numbers (%). TCZ, tocilizumab; AE, adverse events; IV, intravenous; G, giga; N, normal; GC, glucocorticoid; CTCAE, Common Toxicity Criteria for Adverse Events
^aOccurred post-surgery for a programmed cholecystectomy. TCZ was temporally stopped for 2 months

Authors and Disclosures

Hubert de Boysson^1,2*, Maelle Le Besnerais³, Félix Blaison⁴, Aurélie Daumas⁵, Pierre-André Jarrot⁵, François Perrin⁶, Nathalie Tieulié⁷, Alexandre Maria⁸, Pierre Duffau⁴, Bruno Gombert⁹, Maxime Samson¹⁰, Olivier Espitia¹¹, Marc Lambert¹², Arsène Mékinian¹³ and Achille Aouba^1,2 and for the French Study Group for Large Vessel Vasculitis (GEFA)

¹Department of Internal Medicine, Caen University Hospital, Avenue de la Côte de Nacre, 14000 Caen, France. ²Normandy University, Unicaen, Caen, France. ³Department of Internal Medicine, Rouen University Hospital, Dijon, France. ⁴Department of Internal Medicine, Bordeaux University Hospital, Bordeaux, France. ⁵Department of Internal Medical and Clinical Immunology, Conception University Hospital, Marseille, France. ⁶Department of Internal Medicine, Saint-Nazaire Hospital, Saint-Nazaire, France. ⁷Department of Rheumatology, Nice University Hospital, Nice, France. ⁸Department of Internal Medicine, Montpellier University Hospital, Montpellier, France. ⁹Department of Rheumatology, La Rochelle Hospital, La Rochelle, France. ¹⁰Department of Internal Medicine, Dijon University Hospital, Dijon, France. ¹¹Department of Internal Medicine, Nantes University Hospital, Nantes, France. ¹²Department of Internal Medicine, Lille University Hospital, Lille, France. ¹³Department of Internal Medicine, Saint-Antoine Hospital, Paris, France.

*Correspondence
deboysson-h@chu-caen.fr

Authors' contributions
HdB: study concept and design, acquisition of data, analysis and interpretation of data, and drafting of the manuscript. MLB, FB, AD, PAJ, FP, NT, AM, PD, BG, MS, OE, ML, AM, and AA: acquisition of data and critical review; HdB: methodology. All authors read and approved the final manuscript.

Competing interests
Hubert de Boysson is a consultant for and received consulting fees from Roche-Chugai; François Perrin received speaker's fees from Roche-Chugai; Maxime Samson received fees for symposium and boards from Roche-Chugai and is a consultant for Abbvie; Olivier Espitia received fees for symposium and boards from Roche-Chugai.