Background According to clinical guidelines, treatment with a DMARD should be initiated as soon as possible, and any patient who does not improve with at least one relevant synthetic DMARD is a candidate for a biological one. However, up to one third of the patients treated with a biological DMARD do not accomplish the therapeutic objective.
Objectives To identify and assess the attributes of the biological DMARDs which determine the most suitable treatment of patients with RA.
Methods We performed a systematic search with the following MeSH terms: rheumatoid arthritis, biologic, DMARD, characteristic, efficacy, safety, side effects, pharmacology, route–administration, adherence y cost. More than 500 publications were reviewed, from which we selected 77 attributes: 7 about general aspects, 5 about pharmacological aspects, 18 about efficacy, 31 about safety, 6 administration aspects and 10 related with cost. Between May and September 2015, 12 meetings were held, followed by a Delphi process of 2 rounds in which the degree of importance was awarded to each attribute on a Likert scale from 1 (minimum) to 9 (maximum). The consistency and concordance of the agreement were determined and they were circulated, obtaining the percentage supported for each one of them.
Results 83 Spanish rheumatologists participated, reaching a high degree of agreement with the attributes, 75 with a high importance (97.4%) and none of low importance. Fifteen attributes were ratified by all the participants:
– Product with approved indication in RA as first-line biological.
– Product recommended in the guidelines as first-line biological.
– Product that shows efficacy following the failure of another biological.
– Treatment accompanied by a reduction in articular damage progression.
– Treatment that reduces comorbidities associated with RA.
– Treatment characterised by a sustained long-term response.
– Safe product (globally).
– Proven long-term safety.
– Treatment with a low incidence of serious infections.
– Product that does not increase the incidence of solid malignancies.
– Product that does not increase the incidence of haematological neoplasms.
– Safe product in patients with cardiovascular pathology.
– Safe product in patients with interstitial pulmonary disease.
– Product that has demonstrated a reduction in mortality.
– Product that presents a scant incidence of serious adverse events.
Conclusions There was a high degree of agreement with the selected attributes, none of which were regarded as being of low importance; 15 of them received the full support of the work group. These attributes would help to define the ideal profile of the biological DMARD following the failure of a synthetic or previous biological DMARD.
Acknowledgement Financing: Bristol-Myers Squibb
Disclosure of Interest None declared
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