• Something wrong with this record ?

Oral Glucocorticoids for Skin Fibrosis in Early Diffuse Systemic Sclerosis: A Target Trial Emulation Study From the European Scleroderma Trials and Research Group Database

D. Mongin, M. Matucci-Cerinic, UA. Walker, O. Distler, R. Becvar, E. Siegert, LP. Ananyeva, V. Smith, JJ. Alegre-Sancho, S. Yavuz, M. Limonta, G. Riemekasten, E. Rezus, M. Vonk, ME. Truchetet, F. Del Galdo, DS. Courvoisier, M. Iudici, EUSTAR Collaborators

. 2025 ; 77 (5) : 649-657. [pub] 20250114

Language English Country United States

Document type Journal Article, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc25015996

Grant support
Geneva University Hospitals

OBJECTIVE: The objective of this study is to evaluate whether adding oral glucocorticoids to immunosuppressive therapy improves skin scores and ensures safety in patients with early diffuse cutaneous systemic sclerosis (dcSSc). METHODS: We performed an emulated randomized trial comparing the changes from baseline to 12 ± 3 months of the modified Rodnan skin score (mRSS: primary outcome) in patients with early dcSSc receiving either oral glucocorticoids (≤20 mg/day prednisone equivalent) combined with immunosuppression (treated) or immunosuppression alone (controls), using data from the European Scleroderma Trials and Research Group. Secondary end points were the difference occurrence of progressive skin or lung fibrosis and scleroderma renal crisis. Matching propensity score was used to adjust for baseline imbalance between groups. RESULTS: We matched 208 patients (mean age 49 years; 33% male; 59% anti-Scl70), 104 in each treatment group, obtaining comparable characteristics at baseline. In the treated group, patients received a median prednisone dose of 5 mg/day. Mean mRSS change at 12 ± 3 months was similar in the two groups (decrease of 2.7 [95% confidence interval {95% CI} 1.4-4.0] in treated vs 3.1 [95% CI 1.9-4.4] in control, P = 0.64). Similar results were observed in patients with shorter disease duration (≤ 24 months) or with mRSS ≤22. There was no between-group difference for all prespecified secondary outcomes. A case of scleroderma renal crisis occurred in both groups. CONCLUSION: We did not find any significant benefit of adding low-dose oral glucocorticoids to immunosuppression for skin fibrosis, and at this dosage, glucocorticoid did not increase the risk of scleroderma renal crisis.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25015996
003      
CZ-PrNML
005      
20250731091428.0
007      
ta
008      
250708s2025 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1002/acr.25469 $2 doi
035    __
$a (PubMed)39542851
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Mongin, Denis $u Geneva University Hospitals, Geneva, Switzerland $1 https://orcid.org/0000000248018395
245    10
$a Oral Glucocorticoids for Skin Fibrosis in Early Diffuse Systemic Sclerosis: A Target Trial Emulation Study From the European Scleroderma Trials and Research Group Database / $c D. Mongin, M. Matucci-Cerinic, UA. Walker, O. Distler, R. Becvar, E. Siegert, LP. Ananyeva, V. Smith, JJ. Alegre-Sancho, S. Yavuz, M. Limonta, G. Riemekasten, E. Rezus, M. Vonk, ME. Truchetet, F. Del Galdo, DS. Courvoisier, M. Iudici, EUSTAR Collaborators
520    9_
$a OBJECTIVE: The objective of this study is to evaluate whether adding oral glucocorticoids to immunosuppressive therapy improves skin scores and ensures safety in patients with early diffuse cutaneous systemic sclerosis (dcSSc). METHODS: We performed an emulated randomized trial comparing the changes from baseline to 12 ± 3 months of the modified Rodnan skin score (mRSS: primary outcome) in patients with early dcSSc receiving either oral glucocorticoids (≤20 mg/day prednisone equivalent) combined with immunosuppression (treated) or immunosuppression alone (controls), using data from the European Scleroderma Trials and Research Group. Secondary end points were the difference occurrence of progressive skin or lung fibrosis and scleroderma renal crisis. Matching propensity score was used to adjust for baseline imbalance between groups. RESULTS: We matched 208 patients (mean age 49 years; 33% male; 59% anti-Scl70), 104 in each treatment group, obtaining comparable characteristics at baseline. In the treated group, patients received a median prednisone dose of 5 mg/day. Mean mRSS change at 12 ± 3 months was similar in the two groups (decrease of 2.7 [95% confidence interval {95% CI} 1.4-4.0] in treated vs 3.1 [95% CI 1.9-4.4] in control, P = 0.64). Similar results were observed in patients with shorter disease duration (≤ 24 months) or with mRSS ≤22. There was no between-group difference for all prespecified secondary outcomes. A case of scleroderma renal crisis occurred in both groups. CONCLUSION: We did not find any significant benefit of adding low-dose oral glucocorticoids to immunosuppression for skin fibrosis, and at this dosage, glucocorticoid did not increase the risk of scleroderma renal crisis.
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a ženské pohlaví $7 D005260
650    12
$a difuzní sklerodermie $x farmakoterapie $x patologie $x diagnóza $7 D045743
650    _2
$a aplikace orální $7 D000284
650    12
$a glukokortikoidy $x aplikace a dávkování $x škodlivé účinky $7 D005938
650    _2
$a fibróza $7 D005355
650    _2
$a dospělí $7 D000328
650    12
$a kůže $x patologie $x účinky léků $7 D012867
650    12
$a imunosupresiva $x aplikace a dávkování $x škodlivé účinky $7 D007166
650    _2
$a databáze faktografické $7 D016208
650    _2
$a výsledek terapie $7 D016896
650    _2
$a kombinovaná farmakoterapie $7 D004359
650    12
$a prednison $x aplikace a dávkování $x škodlivé účinky $7 D011241
651    _2
$a Evropa $7 D005060
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Matucci-Cerinic, Marco $u IRCCS San Raffaele Scientific Institute, IRCCS San Raffaele Hospital, and Vita-Salute San Raffaele University, Milan, Italy
700    1_
$a Walker, Ulrich A $u University Hospital Basel, Basel, Switzerland
700    1_
$a Distler, Oliver $u University Hospital Zurich, Zurich, Switzerland $1 https://orcid.org/0000000205468310
700    1_
$a Becvar, Radim $u University, Prague, Czech Republic
700    1_
$a Siegert, Elise $u Charité University Hospital, Berlin, Germany
700    1_
$a Ananyeva, Lidia P $u V.A. Nasonova Research Institute of Rheumatology Russian Federation, Moskow, Russia
700    1_
$a Smith, Vanessa $u Ghent University, Ghent University Hospital, and VIB Inflammation Research Center, Ghent, Belgium
700    1_
$a Alegre-Sancho, Juan Jose $u Hospital Universitario Doctor Peset, Valencia, Spain $1 https://orcid.org/0000000316410875
700    1_
$a Yavuz, Sule $u Istanbul Bilim University, Altunizade-Istanbul, Turkey
700    1_
$a Limonta, Massimiliano $u ASST Papa Giovanni XXIII, Begamo, Italy
700    1_
$a Riemekasten, Gabriela $u Klinik Für Rheumatologie Und Klinische Immunologie, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
700    1_
$a Rezus, Elena $u Grigore T. Popa University of Medicine and Pharmacy Iasi, Rehabilitation Hospital Iasi, Romania $1 https://orcid.org/0000000281752583
700    1_
$a Vonk, Madelon $u Radboud University Medical Center, Nijmegen, The Netherlands $1 https://orcid.org/0000000222669907
700    1_
$a Truchetet, Marie-Elise $u National Reference Center for Systemic Autoimmune Rare Diseases, Bordeaux University Hospital, Hôpital Pellegrin, Bordeaux, France
700    1_
$a Del Galdo, Francesco $u Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom $1 https://orcid.org/0000000285282283
700    1_
$a Courvoisier, Delphine S $u Geneva University Hospitals, Geneva, Switzerland
700    1_
$a Iudici, Michele $u Geneva University Hospitals, Geneva, Switzerland $1 https://orcid.org/0000000158718806
710    2_
$a EUSTAR Collaborators
773    0_
$w MED00172712 $t Arthritis care & research $x 2151-4658 $g Roč. 77, č. 5 (2025), s. 649-657
856    41
$u https://pubmed.ncbi.nlm.nih.gov/39542851 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250708 $b ABA008
991    __
$a 20250731091422 $b ABA008
999    __
$a ok $b bmc $g 2366686 $s 1253121
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2025 $b 77 $c 5 $d 649-657 $e 20250114 $i 2151-4658 $m Arthritis care & research $n Arthritis Care Res (Hoboken) $x MED00172712
GRA    __
$p Geneva University Hospitals
LZP    __
$a Pubmed-20250708

Find record

Citation metrics

Archiving options