5PSQ-070 Influence of pathology in injection pain reduction with a new formulation of original adalimumab

Abstract

administration route (oral/injectable/intravenous), treatment satisfaction and treatment decision-making. This questionnaire was elaborated and validated by an MS expert committee (hospital pharmacists, neurologist, patients' associations: Fundación Esclerosis Múltiple Madrid (nurses) and Esclerosis Múltiple España (clinical psychologists). Results One-hundred and fifty-seven MS patients (44 males/ 113 females) were included. The adherence rate was 71% (Morisky-Green scale), and was associated with: older age (mean: 45.2 years compliance; 40.4 years non-compliance), better cognitive status, being married/in-union, more lines of prior treatments, time to diagnosis of 5-10 years, exacerbations absence, clear information about the disease and high treatment satisfaction (table ). There were no differences in the adherence rate between oral (63%) and injectable (77%) treatments. Analysing the injectable administration, there was greater adherence in patients with IV (100%) vs SC (68%). There was also a significant difference between IV (100%) vs oral (63%) (p=0.001). The main cause for non-compliance was forgetfulness (27%). Conclusion Adherence rate for the MS treatment is acceptable (71%). It is negatively affected by forgetfulness, lower cognitive status and lack of family support. The injectable route shows higher adherence than the oral route, although the latter show the highest patient satisfaction. REFERENCES AND/OR ACKNOWLEDGEMENTSStudy supported by Roche, Spain. We gratefully acknowledge AMBER for its contribution (data collection/statistical analysis).No conflict of interest.

A Systematic Literature Review of Injection Site Pain Perception in Adult Patients Treated with Citrate-Free and Citrate-Containing Biologic Agents

“…The two selected real-world studies included one prospective study and one retrospective chart review, with a total of 226 patients [ 23 , 24 ]. Both studies directly compared a CC version of adalimumab with a CF formulation of the same agent and enrolled RA patients, while the prospective study also included patients with other indications.…”

“…The prospective study of Martínez-Casanova et al , 2019 [ 23 ] enrolled 201 patients of varying indications who had received both the previous CC adalimumab version and the newer CF version. Median VAS scores for the four investigated indications ranged from 4.0 cm to 6.0 cm with the CC formulation and from 0.0 cm to 2.0 cm with the CF formulation.…”

“…One important consideration for this review is the fact that formulation effects have been compared across a range of biologic agents and treated indications. Notably, in the majority of included studies comparing formulations which differ regarding the excipient citrate, patients were treated with the TNF-α inhibitor adalimumab or biosimilars of the latter [ 23 - 26 , 28 ]. Conversely, a range of different agents was investigated in the included placebo-controlled trials, which reported on citrate presence within the intervention’s formulation.…”

“…Specific limitations exist regarding individual studies: In two of the studies comparing CF with CC versions of adalimumab, the CF formulation was administered using a smaller syringe and a smaller injection volume [ 23 , 26 ]. This may have additionally influenced ISP perception as injection volume and needle size affect the development of reactions at the injection site [ 16 , 17 ].…”

“…It also needs to be noted that in one study reporting lower VAS scores for a CF formulation, this treatment was administered via auto-injection pen while the CC formulation administered was given via a pre-filled syringe [ 25 ]. Furthermore, three of the investigated direct comparison publications are conference abstracts [ 23 , 25 , 28 ], impeding the investigation of study design and patient characteristics as well as the quality assessment of these studies.…”