Safety and Efficacy of Gevokizumab in Patients with Behçet’s Disease Uveitis: Results of an Exploratory Phase 2 Study

Figures & data

FIGURE 1. Trial design. Acute patients had a second dose injected at the time of response (days 14 or 21). Participation in the follow-up period between 168 and 336 days was optional. IV, intravenously; SC, subcutaneously.*See Methods for exact details of dose regimens.

FIGURE 2. Flow chart of patients. *Patient did not continue after day 168.

TABLE 1. Baseline characteristics of patients.

	Acute patients (N = 17)	At-risk patients (N = 4)	All patients (N = 21)
Demographic characteristics
Age (years)	34.1 ± 9.0	33.5 ± 12.0	34.0 ± 9.3
Men (n)	13	3	16
Asian ethnic origin (n)	10	1	11
Disease characteristics
Behçet’s disease duration (months)	21.0 (0–122)	39.0 (5–83)	21.0 (0–122)
Uveitis duration (months)	25.0 (6; 114)	26.0 (5; 84)	25.0 (5; 114)
Type of uveitis (n)
• Posterior uveitis	2	1	3
• Panuveitis	15	3	18
Number of ocular exacerbations
• In the previous 2 years	3.8 ± 1.6	2.3 ± 1.0	3.5 ± 1.6
• In the previous 6 months	1.4 ± 1.2	0.8 ± 0.5	1.2 ± 1.1
Ophthalmological parameters*
• BCVA by ETDRS (letters)	35.4 ± 22.7	61.5 ± 21.3	-
• Vitreous haze (n)
- SUN score = 0	2	3	-
- SUN score = 1+	2	-	-
- SUN score = 2+	5	1	-
- SUN score = 3+	7	-	-
- SUN score = 4+	1	-	-
• Retinal infiltrates^† (n)	12	-	-
• Retinal vasculitis^† (n)	11	-	-
• FFA subscore^‡	13.0 ± 6.8	13.7 ± 4.5	-
• BenEzra score	5.13 ± 3.96	0.50 ± 0.6	-
Background treatment
• Prednisolone plus one immunosuppressive drug (n)	10^§	1	11
• Prednisolone plus two immunosuppressive drugs (n)	7	3	10

Values and numbers are median (range) or mean ± SD. *In eye with ocular exacerbation at study entry in acute patients, and eye with most recent ocular exacerbation prior to study entry in at-risk patients. ^†Fundus assessment by ophthalmoscopy. ^‡FFA score centrally assessed. ^§One of these patients interrupted immunosuppressive drugs 1 day before randomization and restarted 4 days later.

TABLE 2. Emergent adverse events most frequently reported during the treatment period in acute and at-risk patients according to system organ classes.

Adverse events*	All patients (N = 21)
	Number of events	Number of patients
Eye disorders	12	9
• Cataract	4	4
• Macular edema	3	2
• Glaucoma	1	1
• Optic atrophy	1	1
• Retinal infiltrates	1	1
• Uveitic glaucoma	1	1
• Vitreous hemorrhage	1	1
Vascular disorders	8	7
• Behcet’s disease^#	7	6
• Hypertension	1	1
Respiratory, thoracic, and mediastinal disorders	3	3
• Oropharyngeal pain	3	3
Infections and infestations	3	2
• Abscess	1	1
• Pyelonephritis	1	1
• Upper respiratory tract infection	1	1
Musculoskeletal and connective tissue disorders	3	2
• Myalgia	3	2
Nervous system disorders	2	2
• Headache	2	2

*Events occurring at a rate >5%, ^#Mostly corresponding to a worsening of uveitis.

FIGURE 3. Rapid increase in cumulative percentage of responders in 14 acute patients evaluable for treatment response during the response phase.

FIGURE 4. Marked improvement of ophthalmologic parameters in acute patients during response phase (including acute patients withdrawn before evaluation of response): (a) BCVA; (b) vitreous haze; and (c) BenEzra score (one eye not evaluated due to high vitreous haze). Data during response phase are provided up to the day 14 visit (all but one patient responded by day 14 although one patient had a supplementary visit to confirm response at day 21).