Article Figures & Data
Tables
- Table 1.
Summary of clinical therapeutic studies with dactylitis as a primary or secondary outcome.
Article Study Population Study Type Study Size Study Medication Outcome Variable Outcome Data Study Duration p Effect Size Kavanaugh (PALACE 1)3 Multicenter (n = 83) in 13 countries DB-RPC, crossover at 16 wks n = 504 APR vs Pbo No. of dactylitic digits Mean ± SEM change from baseline at 24 wks: Pbo = −1.3 ± 0.27, APR (40 mg) = −2.0 ± 0.30, APR (60 mg) = −1.8 ± 0.27 24 wks > 0.05 N/A Mease (RAPID-PsA)4 Multicenter (n = 92) in North America, Latin America, & Europe DB-RPC to 24 wks, dose-blinded 24–48 wks, open-label 48–216 wks n = 409 CZP vs Pbo LDI Mean change (SD) from baseline at 24 wks: Pbo = −22.0 ± 46.9, CZP (200 mg) = −40.7 ± 34, CZP (400 mg) = −53.5 ± 69.1 24 wks 0.002 (200 mg); ≤ 0.001 (400 mg) 0.50, combined CZP 200 mg and 400 mg doses Ritchlin (PSUMMIT 2)5 Multicenter (n = 189) in North America, Europe, & Asia Pacific regions DB-RPC, crossover at 24 wks n = 312 UST vs Pbo Dactylitis scored 0–3 Change at 24 wks: 64.6% improvement in median dactylitis score in UST 90-mg vs Pbo. Change at 52 wks: median improvement 95% in pooled UST patients 24, 52 wks > 0.05 0.29, combined UST groups for PSUMMIT1 & 2 pooled data* McInnes (PSUMMIT 1)6 Multicenter (n = 104) in North America & Europe DB-RPC, crossover at 24 wks n = 615 UST vs Pbo % with dactylitis; dactylitis scored 0–3 Change at 24 wks: % patients with dactylitis in UST (combined 45/90 mg) 56.2% vs 76.1% in Pbo. ∼70% improvement in median dactylitis score in UST (combined) vs Pbo. 100% improvement in dactylitis scores for UST patients out to 52 wks 24, 52 wks 0.001 for % with dactylitis; 0.003 for dactylitis scores 0.29, combined UST groups for PSUMMIT1 & 2 pooled data* Gladman7 Single Center in Canada cohort Prospective from historical (10 years) n = 294 DMARD vs Biologic % with complete resolution; % with > 50% improvement No. of dactylitic digits Change at 6 mo, response: Biologic 77.3%, in DMARD 51.5%. Change at 1 year, response: Biologic 87.2%, DMARD 69.9%. 6, 12 mo N/A N/A Kavanaugh (GO-REVEAL)8 Multicenter (n = 58 sites) in the US, Canada, & Europe DB-RPC, crossover at 24 wks n = 405 GOL vs Pbo Dactylitis scored 0–3 Mean ± SD change from baseline at 24 wks: Pbo = 57.2 ± 81.2, GOL (combined 50/100 mg) = 76.6 ± 53.5, GOL (100 mg) = 83.0 ± 45.9 24 wks N/A N/A Kavanaugh (GO-REVEAL)9 Multicenter (n = 58 sites) in the US, Canada, & Europe DB-RPC, crossover at 24 wks n = 405 GOL vs Pbo Dactylitis scored 0–3 Change at 24 wks, improved: GOL (combined 50/100 mg) 74%, GOL (100 mg) 82%, Pbo 28%. Change at 52 wks: Numerically less (52%) had improvement in Pbo vs GOL combined (76.6%) or GOL 100 mg (82%) 24, 52 wks 0.002 at 24 wks, N/A at 52 wks N/A Cantini10 Single center in Italy Prospective followup case-control n = 76 ADM ± MTX % with dactylitis of hands/feet Change at 36 mo: data not reported 36 mo N/A N/A Baranauskaite11 Multicenter (n = 25 +B1 sites) in Europe, Middle East, South Africa, & Turkey OL n = 115 MTX ± INX No. of dactylitic digits Change at 16 wks (median reduction of ≥ 2 dactylitic digits): MTX = no reduction, MTX+INX = magnitude of reduction not reported, but statistically significant 16 wks 0.0006 N/A Saougou12 Single center in Greece OL n = 65 ADM (n = 30), ETN (n = 25), INX (n = 10) % with dactylitis of hands/feet Change at 60 mo: 22% no longer had dactylitis 60 mo N/A N/A Karanikolas13 Single center in Greece OL n = 170 ADM ± CyA Dactylitis scored 0–3 Change at 12 mo (≥ 50% reduction in dactylitis score): CyA = 28.5%, ADM = 75%, CyA+ADM = 100% 12 mo N/A N/A Jung14 Single center in Germany OL n = 20 ANA ± DMARD Dactylitis score (not described) Change at 12 wks: 30% of patients had improved dactylitis scores, 5%+worse, 5%+stable, 5% had undulating course 12 wks N/A N/A Gladman15 Multicenter (n = 24 sites) in Canada OL n = 127 ADM (prior treatment failures) % with in dactylitis ≥ 4 digits of hands/feet, dactylitis scored 0–3 Change at 12 wks: % of patients with ≥ 4 dactylitic digits dropped from 33.9% to 11%. Mean ± SD dactylitis scores decreased from 7.04 ± 6.45 to 2.49 ± 4.68 12 wks < 0.001 for both outcomes N/A Sterry (PRESTA)16 Multicenter (n = 98 sites) in Europe, Latin America, & Asia Pacific regions DB-RPC n = 752 ETN 50 mg twice vs once weekly Dactylitis scored 0–3 Change at 12, 24 wks: Baseline score decreased 74.3–78.4% at 12 wks and 84.5–84.8% at 24 wks 12, 24 wks N/A N/A Kavanaugh (GO-REVEAL)17 Multicenter (n = 58 sites) in US, Canada, & Europe DB-RPC, crossover at 16 wks n = 405 GOL vs Pbo % with dactylitis of hands/feet, dactylitis scored 0–3 Change at 14, 24 wks: % of patients with dactylitis was unchanged. Dactylitis scores, median % change: GOL 100 mg = 100% at 14, 24 wks; Pbo = 0 at 14, 24 wks 14, 24 wks 0.009 at 14 wks, < 0.001 at 24 wks N/A Gottlieb18 Multicenter (n = 24 sites) in US, Canada, & Europe DB-RPC crossover at 12 wks n = 146 UST vs Pbo Dactylitis scored 0–3 Change at 12 wks (median [IQR] improvement): UST = 2.0 (0.0–4.0), Pbo = 0.0 (–1.0–1.5) 12 wks 0.0107 N/A Mease (ADEPT, 2-year data)19 Multicenter (n = 50 sites) in US, Canada, & Europe DB-RPC, crossover at 24 wks, OL extension to 120 wks n = 245 ADM vs Pbo Dactylitis scored 0–3 Mean ± SD change from baseline at 48 wks: 1.3 ± 4.8, Change at 104 wks: 1.4 ± −3.7 48, 104 wks of treatment > 0.05 N/A Healy20 Single-center study in Britain OL n = 17 MTX (n = 12), HC (n = 1), ETN (n = 1), INX (n = 1) LDI, LDI basic, dactylitis scored 0–3, No. dactylitic digits (tender, nontender), No. dactylitic digits (tender), MRI scores All clinical indices of dactylitis improved during 6-mo period as did MRI scores for the hand or foot; no primary data provided. 6 mo N/A N/A Antoni (IMPACT 1, 2-year data)21 Multicenter (n = 9 sites) in Europe, US, & Canada DB-RPC crossover at 16 wks n = 104 INX vs Pbo No. of dactylitic digits Mean ± SD change from baseline at 50 wks: INX = 0.32 ± 0.96, Change at 98 wks: INX = 0.19 ± 0.72 50, 98 wks N/A N/A Kavanaugh (IMPACT 2, 1-year data)22 Multicenter (n = 36 sites) in US, Canada, & Europe DB-RPC crossover at 24 wks (early escape at 16 wks) n = 200 INX vs Pbo % with dactylitis of hands/feet Change at 24 wks, % patients with dactylitis: INX = 34.0% vs Pbo = 11.8%. Change at 54 wks, % patients with dactylitis: INX = 14.8% vs Pbo = 12.2% 24, 54, wks < 0.001 at 24 wks N/A Genovese23 Multicenter (n = 16 sites) in US & Canada DB-RPC n = 100 ADM vs Pbo Dactylitis scored 0 to 3 Mean change in dactylitis score at 12 wks: ADM = −2.4, Pbo = −1.4 12 wks > 0.05 N/A Healy24 Single center in Britain OL n = 28 MTX (n = 19), LEF (n = 4), dactylitis HC (n = 1), ETN (n = 4) LDI, LDI basic, scored 0–3, No. of dactylitic digits (tender /nontender), No. of dactylitic digits (tender) Change at 6 mo: various treatments pooled, effect sizes reported 6 mo N/A LDI (0.99), LDI basic (0.9), dactylitis score (1.63), No. tender/nondactylitic digits (0.77), No. tender dactylitic digits (1.27) Antoni (IMPACT 1)25 Multicenter (n = 9 sites) in Europe, US, & Canada DB-RPC n = 104 INX vs Pbo Dactylitis scored 0–3 Change at 16 wks (mean ± SD): INX = 1.94 ± 0.23, Pbo = 0.58 ± 0.20 16 wks < 0.001 0.41 Antoni (IMPACT 2)26 Multicenter (n = 36 sites) in Europe, US, & Canada DB-RPC n = 200 INX vs Pbo % with dactylitis of hands/feet Change at 14 wks (% reduction in patients with dactylitis): INX = −23, Pbo = −13 14 wks 0.025 N/A Mease27 Multicenter (n = 50 sites) in US, Canada, & Europe DB-RPC n = 249 ADM vs Pbo Dactylitis scored 1–4 Results not provided. No statistical difference at 24 wks 24 wks N/A N/A Kaltwasser (TOPAS)28 Multicenter (n = 31 sites) in Australia, Europe, Canada, & New Zealand DB-RPC n = 186 LEF vs Pbo Dactylitis scored 1 to 4 Mean ± SD change from baseline at 24 wks: LEF = −0.9 ± 2.7, Pbo = −0.2 ± 2.4 24 wks 0.2 0.33 Salvarani29 Multicenter study in Europe OL n = 16 INX added to MTX No. of dactylitic digits (tender) Change at 30 wks: no dactylitis was observed during the study period 30 wks N/A N/A Salvarani30 Multicenter study in Europe OL n = 99 SSZ vs CyA vs ST No. of dactylitic digits enough Change at 24 wks: not data to be clinically meaningful [Only 4 subjects developed dactylitis (1 SSZ, 2 CyA, 1 ST)] 24 wks N/A N/A Clegg31 Multicenter study of US Veterans DB-RPC n = 221 SSZ vs Pbo No. of dactylitic digits (tender & nontender) Mean ± SD change from baseline at 36 wks: SSZ = −0.5 ± 4.2, Pbo = −0.9 ± 4.1 36 wks 0.43 0.2 -
↵* Primary data for this analysis generously provided by Janssen Pharmaceuticals. DB-RPC: Double-blinded, randomized, placebo-controlled trial, OL: Open-label study, N/A: Not applicable, DMARD: Disease-modifying antirheumatic drug, SD: Standard deviation, SEM: Standard error of the mean, IQR: Interquartile range, LDI: Leeds Dactylitis Index; APR: Apremilast, CZP: Certolizumab, UST: Ustekinumab, Pbo: Placebo, GOL: Golimumab, ADM: Adalimumab, MTX: Methotrexate, INX: Infliximab, ETN: Etanercept, CyA: Cyclosporin A, ANA: Anakinra, HC: Hydroxychloroquine, LEF: Leflunomide, SSZ: Sulfasalazine, ST: Standard therapy.
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