FRI0429 NON TOPICAL PHARMACOLOGICAL TREATMENT OF EARLY, UNTREATED (DMARD-NAïVE, SYSTEMIC THERAPY-NäIVE) PSORIATIC DISEASE: A SYSTEMATIC REVIEW

Abstract

BackgroundPsoriatic disease (PsD) refers to a systemic condition, probably driven by chronic and complex inflammatory mechanisms. PsD patients experience a fickle mixture of cutaneous (nail dystrophy, psoriatic lesions spectrum) and musculoskeletal (MSK: arthritis, enthesitis, dactylitis, spondylitis) inflammatory features, variously associated with other co-morbidities (ocular or bowel inflammatory disease, increased cardiovascular risk and metabolic syndrome).Current evidence is limited in respect of the management of early, treatment-naïve PsD.ObjectivesTo assess the literature with a focus on pharmacological interventions in early, treatment-naïve PsD.MethodsSeven research questions were formulated according to the PICO approach: are interventions effective in obtaining control of overall PsD activity? Are interventions effective on peripheral arthritis? On dactylitis? On spondylitis? On enthesitis? On skin and nails?The search was designed as a systematic review of the literature. Early PsD was defined as disease duration ≤2 years, except for studies investigating outcomes restricted to the skin.Criteria for including records were: adult human participants; participants with cutaneous features of PsD; participants with MSK features of PsD; double blind, single blind and non-blinded RCT; well-designed prospective studies/series.The search protocol was registered on PROSPERO [1], the search was performed between June 2018 and January 2019.ResultsResources available were widely explored (4 databases, 5 trial registers, 5 conference archives; see figure). The search retrieved 156,348 references (publication range 1946–2019) of which 308 (0.2%) qualified for full-text-assessment (FTA, figure); 7 (0.0004%) fulfilled the selection criteria and only 4 underwent data extraction.FigureRef. typePsD feature targetedIntervention (success)Primary outcome1 RCTSkinSecukinumab (yes) vs fumarates (no)PASI752 cohortMSKMTX part of T2T (yes)Unclear3 RCTMSKMTX (partial)Joint count4 RCTSkinApremilast (yes)PGAxBSAMeta-analysis was impossible due to data heterogeneity (disease classification criteria, outcome measures and intervention durations). Although no clinical study adopted comprehensive composite indexes as primary outcome measures, 40% of FTA references described more than one component of PsD (i.e.: cutaneous and MSK) at least within the baseline characteristics. A substantial proportion of FTA references did describe, among participants recruited, many who were early untreated PsD at baseline. Unfortunately, separate analyses were not possible due to unavailability of the original datasets. A subset (10%) of the FTA references did not report on the participants’ exposure to previous treatment.ConclusionFew studies addressed early, treatment naïve PsD. The underrepresentation of such data may be related to trial-enrolment criteria. More studies are needed to investigate this identified unmet need.References[1] http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018097366AcknowledgementThe authors wish to thank lib...

Systematic literature review of non-topical treatments for early, untreated (systemic therapy naïve) psoriatic disease: a GRAPPA initiative

“…In fact, many identified studies did investigate drugs not originally encompassed in the protocol of this project, including agents such as tildrakizumab and bimekizumab alongside others ( Supplementary Table S1 , available at Rheumatology Advances in Practice online). It is also worth mentioning that the search strategy designed for this review allowed the retrieval of studies that adopted outcome measures that were not formally encompassed in the research questions [ 18 ]. This further expanded the comprehensiveness of the search activities.…”

“…The research questions that were generated followed the patient–intervention–comparator–outcomes standard. Full protocol details are available on PROSPERO [ 18 ].…”

GRAPPA 2019 Project Report

“…Gabriele De Marco reported on the setup of a systematic literature review project entitled "Non-topical pharmacological treatment of early, untreated [disease-modifying antirheumatic drug (DMARD)-naive, systemic therapy-naive] psoriatic disease: a systematic review. 4 " Most trials have been limited with a focus on severe disease of the skin or joints, without looking at more comprehensive indices in outcomes assessment. The target condition was defined so that clinical studies investigating (1) MSK and/or cutaneous manifestations, or (2) untreated psoriatic disease in its early stage could be included.…”