International Survey to Evaluate Current Options for Subcutaneous Injection of Methotrexate (MTX) and a New Button-Free MTX Autoinjector

Figures & data

Table 1 Features of the New Button-Free MTX Autoinjector and Their Importance Rated by Distribution of a Total of 100 Chips per Participant

Ranking		Chips Distributed per Participant^a			Ranking by Mean Value of the Three Subgroups
		Physicians(n=300)	RA Nurses(n=90)	Patients(n=180)
1.	2-step autoinjector (1. Remove cap; 2. Place on skin and push firmly – injection starts)^b	14.1 ± 13.1	18.1 ± 14.9	16.4 ± 17.5	16.2
2.	Small injection volume^c	11.7 ± 12.1	11.0 ± 12.9	9.7 ± 11.7	10.8
3.	Pen is available in 10 different doses (7.5 mg – 30 mg)^d	13.2 ± 11.5	11.1 ± 8.7	8.0 ± 9.2	10.8
4.	Injection time < 5 seconds	8.5 ± 7.5	8.8 ± 7.0	11.1 ± 11.0	9.5
5.	Audible signals at the beginning and end of injection	8.2 ± 6.9	9.0 ± 7.9	7.5 ± 9.1	8.2
6.	Hidden needle	8.9 ± 10.5	6.9 ± 5.8	8.1 ± 9.8	8.0
7.	Small viewing window for the medication	6.5 ± 5.4	6.7 ± 7.1	7.4 ± 7.3	6.9
8.	Visual control of completed injection via marker in the viewing window	7.2 ± 7.3	7.4 ± 11.3	5.9 ± 6.4	6.8
9.	Prominent color code for different dosages	5.3 ± 5.8	5.1 ± 5.3	5.1 ± 6.8	5.2
10.	Large label containing information on substance and dosage	4.6 ± 5.1	5.4 ± 5.1	5.2 ± 6.7	5.1
11.	Announced for the future: Pen components produced in a CO2-neutral manner^e	5.1 ± 6.6	3.6 ± 5.8	4.9 ± 5.8	4.5
12.	Angular pen shape	3.9 ± 6.1	3.8 ± 4.3	5.1 ± 6.3	4.3
13.	Small package^f	2.8 ± 5.4	2.9 ± 4.9	5.6 ± 11.8	3.8

Notes: ^a Mean ± SD; A total of 100 chips for all feature could be distributed according to the relevance – the more important a given aspect is, the more chips to be awarded; ^b no skin fold needed; ^c Injection volume ranges from 0.15 mL to 0.60 mL; ^d Availability of all dosages depends on the country; ^e This feature is currently not available; ^f Refers to single package, only.

Figure 1 Design, function and handling of the new MTX autoinjector.

Note: *This illustration was not shown to the respondents.

Table 2 Characteristics of Physicians and Nurses Participating in the Survey and Satisfaction Levels with MTX Pens Currently Available on the Market

	Rheumatologists (n=189)	Dermatologists (n=111)	RA Nurses (n=90)
Number of physicians/nurses per country
Germany	60 (32%)	41 (37%)	30 (33%)
France	60 (32%)	40 (36%)	30 (33%)
UK	69 (37%)	30 (27%)	30 (33%)
Number of physicians predominantly practicing in hospital	85 (45%)	51 (46%)	N/A
Number of patients currently treated (average ± SD per respondent)	Rheumatoid arthritis:	Moderate or severe psoriasis:	N/A
	322.8 ± 293.4	227.3 ± 283.0
Number of patients within the last 3 months with prescription of (average ± SD per respondent)	Rheumatoid arthritis:	Moderate or severe psoriasis:	Mainly adults with rheumatoid arthritis:
Oral MTX	76.9 ± 105.5	25.2 ± 38.1	N/A
MTX syringe	20.2 ± 29.0	13.6 ± 24.4	N/A
MTX pen	49.4 ± 60.8	26.0 ± 30.6	35.5 ± 28.0
- metoject^®/metex^® PEN	35.9 ± 52.0	18.7 ± 20.4	N/A
- Nordimet^® pre-filled pen	13.6 ± 17.9	8.3 ± 17.0	N/A
- Methofill^® pre-filled injector	3.3 ± 12.3	5.9 ± 14.7	N/A
Number of physicians/nurses who have ever prescribed/trained in use^a
- metoject^®/metex^® PEN	180 (95%)	106 (95%)	80 (89%)
- Nordimet^® pre-filled pen	150 (79%)	56 (50%)	69 (77%)
- Methofill^® pre-filled injector	22 (12%)	15 (14%)	26 (29%)
Satisfaction level
Average ± SD	7.8 ± 1.3	8.0 ± 1.4	8.0 ± 1.2
Number of responses with
Low-two satisfaction level (1 or 2)	0 (0%)	0 (0%)	0 (0%)
Top-two satisfaction level (9 or 10)	47 (25%)	38 (34%)	30 (33%)

Note: ^a The percentages determined for each device were influenced by the inclusion criteria (see method section).

Abbreviations: N/A, not applicable; UK, United Kingdom; SD, standard deviation.

Table 3 Characteristics of Patients Participating in the Survey and Satisfaction Level with MTX Pens Currently Available on the Market

	Rheumatoid Arthritis (n=92)	Moderate or Severe Psoriasis (n=88)
Number of patients per country
Germany	32 (35%)	30 (34%)
France	30 (33%)	30 (34%)
UK	30 (33%)	28 (32%)
Females	50 (54%)	50 (57%)
Age
< 40 years	34 (37%)	35 (40%)
40–59 years	39 (42%)	40 (45%)
≥ 60 years	19 (21%)	13 (15%)
Type of device ever used:
metoject^®/metex^® PEN	56 (61%)	43 (49%)
Nordimet^® pre-filled pen	46 (50%)	48 (55%)
Methofill^® pre-filled injector	8 (9%)	15 (17%)
Self-injection
Always	75 (82%)	68 (77%)
Mostly	17 (18%)	20 (23%)
Duration of using a device^a
> 3 months but up to 6 months	0 (0%)	13 (15%)
> 6 months	92 (100%)	75 (85%)
Satisfaction level
Average ± SD	8.2 ± 1.8	7.7 ± 1.9
Number of responses with
Low-two satisfaction level (1 or 2)	0 (0%)	2 (2%)
Top-two satisfaction level (9 or 10)	46 (50%)	30 (34%)

Notes: ^a Duration of using a pen influenced by inclusion criteria (see method section).

Abbreviations: UK, United Kingdom; SD, standard deviation.

Table 4 Medical Arguments Which Might Advocate the Use of a MTX Pen as Opposed to a PFS

	Rheumatologists (n=189)	Dermatologists (n=111)	RA Nurses (n=90)	Total (n=390)
Dosing / administration	153 (81%)	99 (89%)	74 (82%)	326 (84%)
Needle is not visible	37 (20%)	19 (17%)	11 (12%)	67 (17%)
Reliable/more accurate dose delivery	12 (6%)	11 (10%)	10 (11%)	33 (8%)
Better/more thorough injection/all medication is injected	8 (4%)	4 (4%)	1 (1%)	13 (3%)
Faster administration/speed of the injection	6 (3%)	5 (5%)	2 (2%)	13 (3%)
Ease of use	125 (66%)	83 (75%)	62 (69%)	270 (69%)
Easy to use/application/handling is better	87 (46%)	56 (50%)	43 (48%)	186 (48%)
Automatic injection	12 (6%)	14 (13%)	3 (3%)	29 (7%)
Self-injection/makes self-injection easier	8 (4%)	11 (10%)	7 (8%)	26 (7%)
Less inhibition/apprehension/pen psychologically easier	12 (6%)	10 (9%)	0 (0%)	22 (6%)
Easy dosing/selection/adjustment	8 (4%)	6 (5%)	3 (3%)	17 (4%)
Safety / side effects	47 (25%)	39 (35%)	42 (47%)	128 (33%)
Safer/better safety/patients feel safer	21 (11%)	12 (11%)	28 (31%)	61 (16%)
Comfort of injection/less pain	12 (6%)	14 (13%)	7 (8%)	33 (8%)
No needle-stick injuries	10 (5%)	5 (5%)	7 (8%)	22 (6%)
Less risk of dose error/no possibility of making a mistake	5 (3%)	5 (5%)	3 (3%)	13 (3%)
Indications	35 (19%)	12 (11%)	9 (10%)	56 (14%)
Good for patients with a fear of needles	21 (11%)	10 (9%)	1 (1%)	32 (8%)
Patients with hand deformities/dexterity issues	13 (7%)	1 (1%)	5 (6%)	19 (5%)
Information/education	19 (10%)	12 (11%)	8 (9%)	39 (10%)
Reduced waste/more eco-friendly	9 (5%)	0 (0%)	5 (6%)	14 (4%)
Less training required/intuitive to use	4 (2%)	5 (5%)	1 (1%)	10 (3%)
Efficacy	10 (5%)	8 (7%)	7 (8%)	25 (6%)
Better adherence/compliance	8 (4%)	7 (6%)	3 (3%)	18 (5%)
Efficacy/effectiveness	2 (1%)	0 (0%)	3 (3%)	5 (1%)
Miscellaneous	19 (10%)	7 (6%)	4 (4%)	30 (8%)
Patient preference/acceptance/satisfaction	12 (6%)	4 (4%)	2 (2%)	18 (5%)

Notes: Answers are listed in the Table if given by at least 12 respondents (≥3.0% or if they belong to the top 2 arguments of a specific category); 11 of 390 respondents (3%) with no specific argument due to “Don’t know” (n=3), “None/nothing” (n=6), or “No comment” (n=2).

Figure 2 Ratings of potential benefits by respondents regarding the four most important features of the new MTX autoinjector according to ranking in Table 1.

Notes: For each feature, up to three main benefits could be selected. The benefits have been identified during a preceding qualitative research resulting in different numbers of benefits per feature. With respect to footnote numbers 1 to 9 exact wording in the questionnaire was follows: ¹ Building a skin fold for the injection is not required. The injection can be applied according to the patient’s preference: either one or two hands can be used. ² Thumb is not required; you can trigger it with the whole hand. ³ Advantage in the case of hand deformities / dexterity problems, arthritic diseases / joint problems. ⁴ Even if the dose is adjusted, you can keep the same device. ⁵ The physician can adjust the dosage over a wide range, and in smaller steps; highly individualized treatment possible. ⁶ More individualized dosing options, depending on patients’ requirements. ⁷ Very short injection time, less of a burden for the hand. ⁸ You do not have to hold the pen in the same position for that long. ⁹ Due to the highest concentration possible for MTX, the injection volume is as small as possible and the injection itself is more comfortable and more pleasant.