Real-world experience of ocrelizumab in multiple sclerosis in an Arab population

Figures & data

Table 1. Baseline characteristics of Q-OCRE cohort compared with OPERA I/II.

	Q-OCRE Full Cohort (n = 60)	Q-OCRE RRMS (n = 57)	Q-OCRE aSPMS (n = 3)	OPERA I^b (n = 410)	OPERA II^b (n = 417)	Q-OCRE vs. OPERA I (p-value)	Q-OCRE vs. OPERA II (p-value)
Age (years), mean (SD)	35.4 (10.5)	34.9 (10.4)	46.0 (10.5)	37.1 (9.3)	37.2 (9.1)	.194	.162
Female sex, n (%)	28 (46.7)	27 (47.7)	1 (3.6)	270 (65.9)	271 (65.0)	.004	.006
MS duration (years), mean (SD)	7.8 (6.8)	7.0 (6.2)	21.7 (1.5)	6.74 (6.4)	6.72 (6.4)	.235	.226
Previous DMT^a, n/total (%)	36/60 (61.7)	33/57 (92.0)	3/3 (100.0)	107/408 (26.2)	113/417 (27.1)	<.001	<.001
Interferon beta	4/60 (13.3)	3/57 (10.0)	1/3 (33.3)	81/408 (19.8)	80/417 (19.2)	.231	.271
DMF	12/60 (23.3)	12/57 (21)	–	1/408 (0.2)	–	<.001	–
Teriflunomide	5/60 (10.0)	5/57 (10.5)	–	–	–	–	–
Fingolimod	7/60 (11.7)	7/57 (12.3)	–	1/408 (0.2)	4/417 (1.0)	<.001	<.001
Natalizumab	8/60 (13.3)	6/57 (10.5)	2/3 (66.7)	–	1/417 (0.2)	–	<.001
Reason for initiation/switch
Disease activity, n/total (%)	37/60 (61.7)	37/57 (64.9)	0/3 (0.0)	NA	NA
Disease progression, n/total (%)	7/60 (11.7)	5/57 (8.8)	2/3 (66.7)	NA	NA
Side effects, n/total (%)	5/60 (0.1)	5/57 (0.1)	0/3 (0.0)	NA	NA
PML risk, n/total (%)	2/60 (3.3)	1/57 (1.8)	1/3 (33.3)	NA	NA
Others, n/total (%)	8/60 (13.3)	8/57 (14.0)	0/3 (0.0)	NA	NA
Baseline EDSS, mean (SD)	2.3 (2.6) IQR = 4.0	2.1 (2.4) IQR = 2.5	7.2 (0.6) IQR=^c	2.86 (1.24)	2.78 (1.30)	.106	.165
Relapses in the previous two years ≥1, n/total (%)	31/60 (51.6)	31/57 (54.4)	0	NA	NA	–	–
Mean (SD)	0.61 (0.64)	0.64 (0.64)	NA	1.79 (0.87)	1.78 (0.95)	<.001	<.001
Baseline Gd+/T2 lesions ≥1, n/total (%)	34/56 (60.7)	34/53 (64.1)	0/3 (0.0)	172/405 (42.4)	161/413 (39.0)	.010	.002
Mean (SD)	1.5 (1.9)	1.6 (1.9)	NA	NA	NA	–	–

Abbreviations. RRMS, relapsing–remitting multiple sclerosis; aSPMS, active secondary progressive multiple sclerosis; MS, multiple sclerosis; DMT, disease-modifying therapy; DMF, dimethyl fumarate; EDSS, Expanded Disability Status Scale; IQR, interquartile range; Gd+, gadolinium enhancing; PML, progressive multifocal leukoencephalopathy.

^aLast DMT before initiating ocrelizumab treatment.

^bOPERA I and II data adapted from Hauser et al. [21].

^cQR could be calculated due to the low sample size.

Table 2. Comorbidities in our patients treated with ocrelizumab (n = 37/60).

Type of comorbidity	Diagnosis	n
Cardiovascular risk factors (N = 20, 33%)	Smoker	4
	Diabetes mellitus	4
	Morbid obesity	5
	High blood pressure	2
	Dyslipidaemia	4
	Obstructive sleep apnea	1
Autoimmune (n = 4, 6%)	Autoimmune thyroid disease	3
	Inflammatory bowel disease	1
Psychiatric disorder (n = 3, 5%)	Depression	3
Cardiac disease (n = 1, 1.6%)	Arrhythmia (AF)	1
Neurological diseases (n = 3, 5%)	Epilepsy	3
Surgical procedures (n = 6, 10%)	Bariatric surgery	5
	Cholecystectomy	1
Others (n = 42, 70%)	G6PD deficiency	1
	Vitamin d deficiency	40
	Vitamin b12 deficiency	1

Table 3. Clinical and MRI outcomes in our Q-OCRE cohort.

	Q-OCRE	Q-OCRE	Q-OCRE
	Fill cohort (n = 60)	RRMS (n = 57)	aSPMS (n = 3)
Follow-up (months)
Mean (SD)	19.4 (9.7)	19.3 (9.1)	25.6 (10.1)
Median (IQR/range)	–	18 (12–27)	31 (14–328)
Ocrelizumab infusion
Mean (SD)	3.4 (1.4)	3.0 (1.5)	3.7 (0.5)
Median (IQR/range)	–	3 (2–4.5)	–
Relapse free, n/total (%)	50/60 (83.3)	47/57 (82.5)	3/3 (100)
ARR post-OCR (95% CI)	0.20 (0.10–0.45)	0.21 (0.10–0.46)	0.16(0.07–0.38)
Post-treatment EDSS^a
Mean (IQR)	2.2 (2.4)	2.0 (2.0)	7.2 (^d)
Improvement^b, n/total (%)	4/60 (6.7)	4/57 (7.0)	0
Worsening^c, n/total (%)	3/60 (5.0)	3/57 (5.3)	0
MRI activity, n/total (%)
Gad + lesions ≥1	4/50 (8.0)	4/48 (8.3)	0
NEDA-3, n/total (%)	44/60 (73.3)	41 (71.9)	3/3 (100)

Abbreviations. ARR, annualized relapse rate; RRMS, relapsing–remitting multiple sclerosis; aSPMS, active secondary progressive multiple sclerosis; IQR, interquartile range; NEDA, no evidence of disease activity.

^aQ-OCRE: assessment done at a 12 months follow-up.

^bConfirmed disability improvement for ≥12 weeks.

^cConfirmed disability progression for ≥12 weeks.

^dIQR could be calculated due to the low sample size.

Table 4. Safety data in Q-OCRE cohort vs. pooled OPERA I/II.

Adverse event	Q-OCRE (n = 60)	OPERA I/II (n = 825)	p-Value
Total patients-year (PY)	98	1448
Adverse event leading to discontinuation (rate per 100PY)	0	2.35	.125
Serious adverse events (rate per 100PY)	1.96	5.4	.137
Infections (rate per 100PY)	16	84.5	<.001
Urinary tract infection (n/total %)	3/60 (5.0)	96/825 (11.6)	.117
Upper respiratory tract infections (n/total%)	10/60 (16.6)	125/825 (15.2)	.771
COVID-19 (n/total %)	1/60 (1.6%)	–
Herpes zoster (n/total %)	1/60 (1.6%)	–
Gastroenteritis (n/total %)	1/60 (1.6%)	–
Serious infections (rate per 100PY)	1.96
IRR (rate per 100PY)	9.8
Other
Superficial thrombophlebitis (n/total %)	1/60 (1.6%)

Figure 1. Kaplan–Meier survival curves showing the proportions of patients with multiple sclerosis started on Ocrelizumab remaining with no evidence of disease activity (NEDA) over follow-up time. NEDA: no evidence of disease activity.

Table 5. Cox regression model with the estimated hazard ratios of having evidence of disease activity on Ocrelizumab for different covariates.

	B	SE	Wald	p	HR	95.0% CI for HR
						Lower	Upper
Gender	−.459	.534	.739	.390	.632	.222	1.800
Age	−.016	.030	.292	.589	.984	.928	1.043
Duration of illness	.035	.044	.636	.425	1.036	.950	1.130
Number of relapses during the two years before starting Ocrelizumab	.894	.447	3.995	.046	2.445	1.018	5.874

Abbreviations. CI, confidence interval; HR, hazard ratio.

Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3):221–234.

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