Clinical Research Overview
The EPIPSOFIRE† project: A Preliminary Report
DDR
DRUG DEVELOPMENT RESEARCH 75 : S85–S87 (2014)
Gabriele De Marco,1* Angelo Cattaneo,2 Carlo G. Carrera,2 Patrizia Gibertini,3 Norma Battafarano,3 and Antonio Marchesoni3 1 ULSS 16 Padova, UOS Reumatologia Geriatrica, Sant’Antonio Hospital, 35127 Padova, Italy 2 IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena, UO Dermatologia, 20122 Milan, Italy 3 Az. Osp. Istituto Ortopedico Gaetano Pini, UOC Day Hospital di Reumatologia, 20122 Milan, Italy
Strategy, Management and Health Policy Enabling Technology, Genomics, Proteomics
Preclinical Research
Preclinical Development Toxicology, Formulation Drug Delivery, Pharmacokinetics
Clinical Development Phases I-III Regulatory, Quality, Manufacturing
Postmarketing Phase IV
ABSTRACT Psoriatic arthritis (PsA) is a musculoskeletal condition complicating psoriasis that can lead to joint deformity and disability; however, psoriatic patients may suffer from other kind of arthropathies that could be confused with PsA by nonrheumatologists. Our aim was to determine the prevalence of PsA and to determine the prevalence of other musculoskeletal conditions in a cohort of psoriatic patients. In this cohort, musculoskeletal discomfort was frequently reported, while inflammatory disorders were detected in 20 years) or severe cutaneous disease. Because musculoskeletal discomfort symptoms affected about 62% of patients, other disorders, particularly morphologic conditions, need careful evaluation in psoriasis subjects. Drug Dev Res 75 : S85–S87, 2014. © 2014 Wiley Periodicals, Inc. Key words: musculoskeletal discomfort; psoriatic arthritis; multidisciplinary approach to psoriasis care
INTRODUCTION
Psoriatic arthritis (PsA) is a musculoskeletal condition complicating psoriasis that can lead to joint deformity and disability [Gladman, 2009]. However, psoriatic patients may suffer from other kind of arthropathies, which can be confused with PsA by nonrheumatologists. Our primary endpoint was to determine the prevalence of PsA in a cohort of psoriatic patients who have never reported musculoskeletal complaints. The secondary endpoint was to determine the prevalence of other musculoskeletal conditions (e.g., degenerative disorders) in the same cohort.
to sign written informed consent before enrollment. Two experienced rheumatologists (G.D.M. or P.G.) evaluated candidates, according to the OMERACT [Gladman et al., 2007] guidelines on measurements in PsA and Classification criteria for Psoriatic Arthritis (CASPAR) [Taylor et al., 2006]. Funding/support information: This project was funded by Pfizer Italia Srl through an educational grant. Conflict of interest: None of the authors has any financial interests to disclose. † Italian acronym for “Psoriasis Complicated by Inflammatory Arthropathies Epidemiological Project” (“progetto EPIdemiologico sulla PSoriasi complicata da artrOpatie inFIammatoRiE.”)
Study Design
*Correspondence to: Gabriele De Marco, ULSS 16 Padova, UOS Reumatologia Geriatrica, Sant’Antonio Hospital, via J. Facciolati, 71, 35127 Padova, Italy. E-mail: [email protected]
This was an observational, cross-sectional, monocentric study. Patients were consecutive and had
Published online in Wiley Online Library (wileyonlinelibrary .com). DOI: 10.1002/ddr.21205
MATERIALS AND METHODS
© 2014 Wiley Periodicals, Inc.
S86
DE MARCO ET AL.
Patients Enrolled
RESULTS
Consecutive psoriatic subjects attending the outpatient clinic of our Dermatological Centre in Milan between January 2011 and July 2012 were enrolled. The inclusion criteria were adult age at enrollment; established diagnosis of psoriasis; receiving any standard treatment for psoriasis, topical as well as synthetic agents (methotrexate, cyclosporine A, and acitretin). Patients were excluded if they had skin diseases other than psoriasis; current erythrodermia psoriatica (allowed only if recovered); a previous diagnosis of PsA, established and followed up by a rheumatologist; treatment (current or previous) with a Tumor Necrosis Factor alpha (TNFα) inhibitor or ustekinumab; and any impairment to giving informed consent.
Of those screened, 98.1% of patients were suitable for inclusion (Fig. 1). The data collected after screening are shown in Table 1. Among psoriatic subjects, we identified at least 12 different kind of musculoskeletal conditions, the majority being already identified by other specialists. PsA cases were mostly detected in the early phase (the clinical onset median was 12 weeks).
Statistical Considerations PsA prevalence estimation among psoriatic patients ranges from 13.8% [Ibrahim et al., 2009] to 30% [Mease et al., 2013]. Assuming a conservative 20% estimate, 300 psoriatic patients were deemed appropriate for statistical purposes.
DISCUSSION
In this cohort, musculoskeletal discomfort was frequently reported, while inflammatory disorders were detected in less than 4%. The authors acknowledge that a deceptive effect of systemic medication could have taken place. Furthermore, our cohort lacked subjects with very long-standing psoriasis duration (>20 years) or severe cutaneous disease. CONCLUSIONS
PsA was not frequent in the cohort described. Since musculoskeletal discomfort symptoms affected
Fig. 1. EPIPSOFIRE study flow chart. Target enrolment: 300 patients with psoriasis. DISH, diffuse idiopathic skeletal hyperostosis; PsA, psoriatic arthritis.
Drug Dev. Res.
PSORIASIS AND INFLAMMATORY ARTHROPATHIES
about 62% of patients in our cohort, other disorders, particularly those of a morphological kind, need careful evaluation in psoriasis subjects.
TABLE 1. Enrollment Results Gender Male (%) Female (%) Age at enrollment, in years; mean (SD) Nation of origin Italian, n (%) Anthropometrics Body mass index, mean (SD) Psoriasis Psoriasis duration in years, median (IQR) Plaque type, n (%) Nail psoriasis, n (%) Isolated nail psoriasis, n (%) PASI score, median (IQR) PASI score >10, n (%) Therapies Topical, n (%) Systemic, n (%) Rheumatologic evaluation findings Subjects reporting musculoskeletal discomfort, n (%) Previous orthopedic consultation, n (%) Previous rheumatologic consultation, n (%) Previously performed imaging, n (%) PsA prevalence, n (%) Gout prevalence, n (%) Polymyalgia rheumatica prevalence, n (%) Sarcoidosis prevalence, n (%) Posttraumatic arthritis prevalence, n (%) Giant cells synovial neoplasia prevalence, n (%) DISH prevalence, n (%) Degenerative conditions prevalence, n (%) Morphological conditions prevalence, n (%)
S87
188 (61.2) 119 (38.8) 53.8 (16.3) 281 (91.5) 26.1 (4.5) 11 (4.5–20) 250 (81.4) 141 (45.9) 6 (1.9) 3.1 (1.65–6.55) 35 (11.4) 214 (69.7) 91 (29.6) 191 (62.2) 175 (57) 36 (11.7) 155 (50.5) 8 (2.6) 1 (0.3) 1 (0.3) 1 (0.3) 1 (0.3) 1 (0.3) 2 (0.6) 115 (37.1) 80 (26.1)
ACKNOWLEDGMENT
Editorial assistance was provided by Mary Hines on behalf of HPS—Health Publishing and Services Srl.
REFERENCES Gladman DD. 2009. Psoriatic arthritis. Dermatol Ther 22:40–55. Gladman DD, Mease PJ, Strand V, Healy P, Helliwell PS, Fitzgerald O, Gottlieb AB, Krueger GG, Nash P, Ritchlin CT, et al. 2007. Consensus on a core set of domains for psoriatic arthritis. J Rheumatol 34:1167–1170. Ibrahim G, Waxman R, Helliwell PS. 2009. The prevalence of psoriatic arthritis in people with psoriasis. Arthritis Rheum 61:1373–1378. Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaçi D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, et al. 2013. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol 69:729–735. Taylor W, Gladman D, Helliwell PS, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. 2006. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 54:2665–2673.
DISH, diffuse idiopathic skeletal hyperostosis; IQR, interquartile range; PASI, Psoriasis Area Severity Index; PsA, psoriatic arthritis; SD, standard deviation.
Drug Dev. Res.
The EPIPSOFIRE† project: A Preliminary Report
DDR
DRUG DEVELOPMENT RESEARCH 75 : S85–S87 (2014)
Gabriele De Marco,1* Angelo Cattaneo,2 Carlo G. Carrera,2 Patrizia Gibertini,3 Norma Battafarano,3 and Antonio Marchesoni3 1 ULSS 16 Padova, UOS Reumatologia Geriatrica, Sant’Antonio Hospital, 35127 Padova, Italy 2 IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena, UO Dermatologia, 20122 Milan, Italy 3 Az. Osp. Istituto Ortopedico Gaetano Pini, UOC Day Hospital di Reumatologia, 20122 Milan, Italy
Strategy, Management and Health Policy Enabling Technology, Genomics, Proteomics
Preclinical Research
Preclinical Development Toxicology, Formulation Drug Delivery, Pharmacokinetics
Clinical Development Phases I-III Regulatory, Quality, Manufacturing
Postmarketing Phase IV
ABSTRACT Psoriatic arthritis (PsA) is a musculoskeletal condition complicating psoriasis that can lead to joint deformity and disability; however, psoriatic patients may suffer from other kind of arthropathies that could be confused with PsA by nonrheumatologists. Our aim was to determine the prevalence of PsA and to determine the prevalence of other musculoskeletal conditions in a cohort of psoriatic patients. In this cohort, musculoskeletal discomfort was frequently reported, while inflammatory disorders were detected in 20 years) or severe cutaneous disease. Because musculoskeletal discomfort symptoms affected about 62% of patients, other disorders, particularly morphologic conditions, need careful evaluation in psoriasis subjects. Drug Dev Res 75 : S85–S87, 2014. © 2014 Wiley Periodicals, Inc. Key words: musculoskeletal discomfort; psoriatic arthritis; multidisciplinary approach to psoriasis care
INTRODUCTION
Psoriatic arthritis (PsA) is a musculoskeletal condition complicating psoriasis that can lead to joint deformity and disability [Gladman, 2009]. However, psoriatic patients may suffer from other kind of arthropathies, which can be confused with PsA by nonrheumatologists. Our primary endpoint was to determine the prevalence of PsA in a cohort of psoriatic patients who have never reported musculoskeletal complaints. The secondary endpoint was to determine the prevalence of other musculoskeletal conditions (e.g., degenerative disorders) in the same cohort.
to sign written informed consent before enrollment. Two experienced rheumatologists (G.D.M. or P.G.) evaluated candidates, according to the OMERACT [Gladman et al., 2007] guidelines on measurements in PsA and Classification criteria for Psoriatic Arthritis (CASPAR) [Taylor et al., 2006]. Funding/support information: This project was funded by Pfizer Italia Srl through an educational grant. Conflict of interest: None of the authors has any financial interests to disclose. † Italian acronym for “Psoriasis Complicated by Inflammatory Arthropathies Epidemiological Project” (“progetto EPIdemiologico sulla PSoriasi complicata da artrOpatie inFIammatoRiE.”)
Study Design
*Correspondence to: Gabriele De Marco, ULSS 16 Padova, UOS Reumatologia Geriatrica, Sant’Antonio Hospital, via J. Facciolati, 71, 35127 Padova, Italy. E-mail: [email protected]
This was an observational, cross-sectional, monocentric study. Patients were consecutive and had
Published online in Wiley Online Library (wileyonlinelibrary .com). DOI: 10.1002/ddr.21205
MATERIALS AND METHODS
© 2014 Wiley Periodicals, Inc.
S86
DE MARCO ET AL.
Patients Enrolled
RESULTS
Consecutive psoriatic subjects attending the outpatient clinic of our Dermatological Centre in Milan between January 2011 and July 2012 were enrolled. The inclusion criteria were adult age at enrollment; established diagnosis of psoriasis; receiving any standard treatment for psoriasis, topical as well as synthetic agents (methotrexate, cyclosporine A, and acitretin). Patients were excluded if they had skin diseases other than psoriasis; current erythrodermia psoriatica (allowed only if recovered); a previous diagnosis of PsA, established and followed up by a rheumatologist; treatment (current or previous) with a Tumor Necrosis Factor alpha (TNFα) inhibitor or ustekinumab; and any impairment to giving informed consent.
Of those screened, 98.1% of patients were suitable for inclusion (Fig. 1). The data collected after screening are shown in Table 1. Among psoriatic subjects, we identified at least 12 different kind of musculoskeletal conditions, the majority being already identified by other specialists. PsA cases were mostly detected in the early phase (the clinical onset median was 12 weeks).
Statistical Considerations PsA prevalence estimation among psoriatic patients ranges from 13.8% [Ibrahim et al., 2009] to 30% [Mease et al., 2013]. Assuming a conservative 20% estimate, 300 psoriatic patients were deemed appropriate for statistical purposes.
DISCUSSION
In this cohort, musculoskeletal discomfort was frequently reported, while inflammatory disorders were detected in less than 4%. The authors acknowledge that a deceptive effect of systemic medication could have taken place. Furthermore, our cohort lacked subjects with very long-standing psoriasis duration (>20 years) or severe cutaneous disease. CONCLUSIONS
PsA was not frequent in the cohort described. Since musculoskeletal discomfort symptoms affected
Fig. 1. EPIPSOFIRE study flow chart. Target enrolment: 300 patients with psoriasis. DISH, diffuse idiopathic skeletal hyperostosis; PsA, psoriatic arthritis.
Drug Dev. Res.
PSORIASIS AND INFLAMMATORY ARTHROPATHIES
about 62% of patients in our cohort, other disorders, particularly those of a morphological kind, need careful evaluation in psoriasis subjects.
TABLE 1. Enrollment Results Gender Male (%) Female (%) Age at enrollment, in years; mean (SD) Nation of origin Italian, n (%) Anthropometrics Body mass index, mean (SD) Psoriasis Psoriasis duration in years, median (IQR) Plaque type, n (%) Nail psoriasis, n (%) Isolated nail psoriasis, n (%) PASI score, median (IQR) PASI score >10, n (%) Therapies Topical, n (%) Systemic, n (%) Rheumatologic evaluation findings Subjects reporting musculoskeletal discomfort, n (%) Previous orthopedic consultation, n (%) Previous rheumatologic consultation, n (%) Previously performed imaging, n (%) PsA prevalence, n (%) Gout prevalence, n (%) Polymyalgia rheumatica prevalence, n (%) Sarcoidosis prevalence, n (%) Posttraumatic arthritis prevalence, n (%) Giant cells synovial neoplasia prevalence, n (%) DISH prevalence, n (%) Degenerative conditions prevalence, n (%) Morphological conditions prevalence, n (%)
S87
188 (61.2) 119 (38.8) 53.8 (16.3) 281 (91.5) 26.1 (4.5) 11 (4.5–20) 250 (81.4) 141 (45.9) 6 (1.9) 3.1 (1.65–6.55) 35 (11.4) 214 (69.7) 91 (29.6) 191 (62.2) 175 (57) 36 (11.7) 155 (50.5) 8 (2.6) 1 (0.3) 1 (0.3) 1 (0.3) 1 (0.3) 1 (0.3) 2 (0.6) 115 (37.1) 80 (26.1)
ACKNOWLEDGMENT
Editorial assistance was provided by Mary Hines on behalf of HPS—Health Publishing and Services Srl.
REFERENCES Gladman DD. 2009. Psoriatic arthritis. Dermatol Ther 22:40–55. Gladman DD, Mease PJ, Strand V, Healy P, Helliwell PS, Fitzgerald O, Gottlieb AB, Krueger GG, Nash P, Ritchlin CT, et al. 2007. Consensus on a core set of domains for psoriatic arthritis. J Rheumatol 34:1167–1170. Ibrahim G, Waxman R, Helliwell PS. 2009. The prevalence of psoriatic arthritis in people with psoriasis. Arthritis Rheum 61:1373–1378. Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaçi D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, et al. 2013. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol 69:729–735. Taylor W, Gladman D, Helliwell PS, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. 2006. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 54:2665–2673.
DISH, diffuse idiopathic skeletal hyperostosis; IQR, interquartile range; PASI, Psoriasis Area Severity Index; PsA, psoriatic arthritis; SD, standard deviation.
Drug Dev. Res.
