Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study

Figures & data

Figure 1 Golimumab injection devices.

Notes: (A) SmartJect autoinjector. (B) Prefilled syringe.

Figure 2 Device preference.

Notes: Patient preference for the different devices was assessed immediately after the injections and 2 weeks later. (A) Device preference according to order of presentation immediately after the injections. (B) Device preference according to order of presentation 2 weeks after the injections. (C) Device preference at week 2 according to preference immediately after the injections. (D) Device preference immediately after the injections according to age group. (E) Device preference immediately after the injections according to Mayo score at baseline.

Table 1 Ease of use, discomfort, and overall impression of the devices

Assessment	Category	Autoinjector			Prefilled syringe
		Autoinjector first	Prefilled syringe first	Overall	Autoinjector first	Prefilled syringe first	Overall
Ease of use of self-injection	Extremely easy	27 (60.0)	26 (56.5)	53 (58.2)	9 (20.0)	15 (32.6)	24 (26.4)
	Easy	17 (37.8)	16 (34.8)	33 (36.3)	20 (44.4)	23 (50.0)	43 (47.3)
	Neither easy nor difficult	1 (2.2)	1 (2.2)	2 (2.2)	11 (24.4)	5 (10.9)	16 (17.6)
	Difficult	0 (0.0)	1 (2.2)	1 (1.1)	2 (4.4)	1 (2.2)	3 (3.3)
	Extremely difficult	0 (0.0)	2 (4.3)	2 (2.2)	3 (6.7)	2 (4.3)	5 (5.5)
Discomfort during self-injection	No discomfort	27 (60.0)	29 (63.0)	56 (61.5)	11 (24.4)	24 (52.2)	35 (38.5)
	Mild discomfort	17 (37.8)	13 (28.3)	30 (33.0)	20 (44.4)	17 (37.0)	37 (40.7)
	Moderate discomfort	1 (2.2)	4 (8.7)	5 (5.5)	9 (20.0)	2 (4.3)	11 (12.1)
	Severe discomfort	0 (0.0)	0 (0.0)	0 (0.0)	3 (6.7)	0 (0.0)	3 (3.3)
	Such discomfort that I cannot inject future doses	0 (0.0)	0 (0.0)	0 (0.0)	2 (4.4)	3 (6.5)	5 (5.5)
Overall impression of the self-injection experience	Extremely favorable	17 (37.8)	26 (56.5)	43 (47.3)	8 (17.8)	18 (39.1)	26 (28.6)
	Favorable	25 (55.6)	13 (28.3)	38 (41.8)	19 (42.2)	21 (45.7)	40 (44.0)
	Neither favorable nor unfavorable	3 (6.7)	5 (10.9)	8 (8.8)	13 (28.9)	4 (8.7)	17 (18.7)
	Unfavorable	0 (0.0)	2 (4.3)	2 (2.2)	3 (6.7)	1 (2.2)	4 (4.4)
	Extremely unfavorable	0 (0.0)	0 (0.0)	0 (0.0)	2 (4.4)	2 (4.3)	4 (4.4)

Note: Data presented as n (%).

Table S1 List of participating ethics committees

UZ Leuven

Commissie Medische Ethiek

Professor Minne Casteels Herestraat 49

B-3000 Leuven

Tel: [phone] Fax [phone]

Email [e-mail]

UZ Gent

Commissie Medische Ethiek

Professor Dirk Matthys

De Pintelaan 185

B-9000 Gent

Tel: [phone] Fax [phone]

Email [e-mail]

AZ Groeninge, Campus Loofstraat

Commissie Medische Ethiek

Dokter Peter Doubel

Loofstraat 43

8500 Kortrijk

Tel: [phone] Fax [phone]

Email [e-mail]

UZ Antwerpen

Commissie Medische Ethiek

Patrick Cras

Wilrijkstraat 10

2650 Edegem

Tel: [phone] Fax [phone]

Email [e-mail]

CHU Sart Tilman

Comité d’Ethique Hospitalo-Facultaire Universitaire de Liège

Professeur V. Seutin

Centre Hospitalier Universitaire du Sart Tilman, B35

4000 Liège

Tel: [phone] Fax [phone]

Email [e-mail]

H Hart Ziekenhuis Roeselare – Menen vzw

Commissie Medische Ethiek

Dr. L. Harlet

Wilgenstraat 2

8800 Roeselare

Tel: [phone] Fax [phone]

Email [e-mail] October 2014 Page 2

Sint Augustinus (GZA Ziekenhuizen)

Commissie Medische Ethiek

Professor Bart Van den Eynden

Sint-Vincentiusstraat 20

2018 Antwerpen

Tel: [phone] Fax [phone]

Email [e-mail]

Zol Genk, Campus St Jan

Comité Medische Ethiek

Doctor Patrick Noyens

Schiepse Bos 6

3600 Genk

Tel: [phone] Fax [phone]

Email [e-mail]

AZ ST Jan Brugge

Commissie Medische Ethiek

Doctor Ludo Vanopdenbossch

Ruddershove 10

8000 Brugge

Tel: [phone] Fax [phone]

Email [e-mail]

UCL St Luc

Commission d’Ethique Biomédicale Hospitalo-Facultaire de l’UCL

Professor J.M. Maloteaux

Avenue Hippocrate 55.14, Tour Harvey, niveau 0

1200 Bruxelles

Tel: [phone] Fax [phone]

Email [e-mail]

CHC St Joseph Liège

Comité d’ethique médicale des cliniques St Joseph

Doctor René Stevens

Rue de Hesbaye 75

4000 Liège

Tel: [phone] Fax [phone]

Email [e-mail]

La citadelle de Liège

Comité d’ethique médicale

Professeur François DAMAS

Boulevard du 12ème de Ligne, 1

4000 Liège

Tel: [phone] Fax [phone]

Email [e-mail]

OLV ziekenhuis Aalst

Ethisch Comité OLV Ziekenhuis

Doctor Antoon Leloup

Moorselbaan 164

9300 Aalst

Tel: [phone] Fax [phone]

Email [e-mail]

Hôpital Erasme

Comité d’Ethique

Prof. Dr. André Herchuelz

Route de Lennik 808

1070 Bruxelles

Tel: [phone] Fax [phone]

Email [e-mail]

GHDC, Saint-Joseph, Charleroi

Comité d’Ethique Hospitalier, Grand Hopital de Charleroi

Mrs Laurence Gillard

Grand Rue 3

6000 Charleroi

Tel: [phone] Fax [phone]

Email [e-mail]

ZNA Jan Palfijn Antwerpen

Dr. P.P. De Deyn

Commissie voor Medische Ethiek ZNA

ZNA Koningin Paola Kinderziekenhuis (P6-lokaal 617)

Lindendreef 1, 2020 Antwerpen

Tel: [phone] of 03/280.34.28 Fax [phone]

Email [e-mail]

Centre Hospitalier de Wallonie picarde – CHwapi A.S.B.L. Site Union

Dr. Luc Desplanque

Comité d’Ethique

39, Boulevard Lalaing

7500 Tournai

Tel: [phone] Fax [phone]

Email [e-mail]/[e-mail]

October 2014 Page 4

Virga Jesse ziekenhuis, Hasselt

Dr. Koen Magerman

Ethische Toetsingscommissie Virga Jesse

Stadsomvaart 11

3500 Hasselt

Tel: [phone] Fax [phone]

Email [e-mail]

CHR Peltzer La Tourelle

Dr. Hassan Kalantari

Comité d’Ethique

Rue du Parc 29

4800 Verviers

Tel: [phone] Fax [phone]

Email [e-mail]

AZ Sint Maarten

Dr. J. Vander Sande

Ethisch comité van vzw Emmaüs

Edgard Tinellaan 1c

2800 Mechelen

Tel: [phone] Fax [phone]

Email [e-mail]

AZ Damiaan

Dr. Guy Fonteyn

Ethisch Comité

Gouwelozestraat 100

8400 Oostende

Tel: [phone] Fax [phone]

Email [e-mail]

AZ St Lucas

Dr. Rob Schildermans

Ethische Commissie

AZ St Lucas Brugge

Sint-Lucaslaan 29

8310 Brugge

Tel: [phone] Fax [phone]

Email [e-mail]

Table S2 Patient demographic characteristics

Characteristic	Value
Number included in the per-protocol analysis	91
Age (years)
Mean (SD)	42.7 (14.4)
Range	19.7–93.7
Sex, n (%)
Male	54 (59.3)
Female	37 (40.7)
Ethnicity, n (%)
White/Caucasian	89 (97.8)
Other	2 (2.2)
Marital status, n (%)
Single	23 (25.3)
Married/living together	67 (73.6)
Widow	1 (1.1)
Highest education level, n (%)
Primary education	6 (6.6)
Vocational secondary education	13 (14.3)
Technical secondary education	13 (14.3)
General secondary education – humanities	12 (13.2)
Higher education (graduate/nonuniversity)	30 (33.0)
Higher education (university)	17 (18.7)
Professional status, n (%)
Student	9 (9.9)
Working full time	48 (52.7)
Working part time	11 (12.1)
Not working	23 (25.3)
Time since UC diagnosis (y)
Mean (SD)	8.6 (8.8)
Range	0.0–38.1
Most frequent concomitant conditions (≥3%), n (%)
Arthritis	4 (4.4)
Arthralgia	4 (4.4)
Psoriasis	3 (3.3)
Primary sclerosing cholangitis	3 (3.3)
Other	6 (6.6)
Previous exposure to anti-TNF, n (%)
Naive	76 (83.5)
Experienced	15 (16.5)
Concomitant medications, n (%)
5-Aminosalicylic acid	68 (74.7)
Corticosteroids	59 (64.8)
Azathioprine	37 (40.7)
Other	2 (2.2)
Total Mayo score
Mean (SD)	8.8 (1.6)
Min, max	6, 12
Total Mayo score categories, n (%)
6	7 (7.9)
7–9	49 (55.1)
≥10	33 (37.1)
Stool frequency, n (%)
Normal	0 (0.0)
1–2 stools more than normal	6 (6.7)
3–4 stools more than normal	41 (45.6)
5 or more stools more than normal	43 (47.8)
Rectal bleeding, n (%)
No blood seen	6 (6.7)
Streaks of blood with stools less than half the time	27 (30.0)
Obvious blood with stool most of the time	37 (41.1)
Blood alone passed	20 (22.2)
Physician’s global assessment, n (%)
Normal	0 (0.0)
Mild disease	4 (4.4)
Moderate disease	65 (72.2)
Severe disease	21 (23.3)
Sigmoidoscopic/endoscopic findings, n (%)
Normal or inactive disease	0 (0.0)
Mild disease	1 (1.1)
Moderate disease	54 (60.7)
Severe disease	34 (38.2)

Abbreviations: UC, ulcerative colitis; TNF, tumor necrosis factor.

Table S3 Treatment-emergent adverse events

Adverse event	Severity	Patients	Onset (time after injections)	Potentially related	Action taken	Resolution (time after onset)
Injection-site hematoma	Mild	1	1 day	Yes	None	6 days
	Mild	1	2 days	No	None	12 days
Injection-site pain	Mild	1	6 days	Yes	None	Ongoing
Palpitations	Mild	1	3 days	No	None	1 day
Flatulence	Moderate	1	6 days	No	None	3 months
Dyspepsia	Mild	1	10 days	No	Medication	3 months
UC flare	Moderate	1	1 day	Yes	Medication	2 months
Viral upper respiratory tract infection	Mild	1	1 day	Yes	None
Headache	Mild	1	3 days	Yes	Medication	Ongoing
Hot flushes	Mild	1	1 day	Yes	None	Ongoing
Hemorrhoidal hemorrhage	Mild	1	9 days	No	None	Ongoing
Tooth sensitivity	Mild	1	6 days	Yes	None	Ongoing
Parotid gland enlargement	Mild	1	12 days	No	Echography	1 month

Abbreviation: UC, ulcerative colitis.