Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis
New England Journal of Medicine, 2017 · paper · Clinical trials
Two identical phase 3 trials of dupilumab versus placebo in adults with moderate-to-severe atopic dermatitis. About 36–38% on dupilumab reached clear or almost clear skin at week 16 versus 8–10% on placebo, with more conjunctivitis.
2 findings
Substance The Discussion says infections were reported "in 28 to 33% of those receiving placebo", but Table 3 and the Results give 63 (28) in SOLO 1 and 76 (32) in SOLO 2, so the range is 28 to 32%.
- p. 10 Discussion, bottom left column
and in 28 to 33% of those receiving placebo
- p. 11 Table 3, Infections and infestations row, placebo columns
63 (28)
- p. 11 Table 3, Infections and infestations row, SOLO 2 placebo
76 (32)
- p. 7 Results, Safety, left column
in 28%, 29%, and 32%, respectively, in SOLO 2
Judge's note: Table 3 (upright page 11), Infections and infestations, placebo: 63 (28) of N=222 and 76 (32) of N=234. The Results on page 7 say 28% in SOLO 1 and 32% for placebo in SOLO 2. In the same Discussion sentence, the dupilumab range of 28 to 35% matches Table 3 (28, 29, 34, 35). No placebo figure in the paper is 33%, and no other analysis set is named.
Second check: another model agreed
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Reference or label The AAD consensus diagnostic criteria ("the consensus criteria of the American Academy of Dermatology19") are cited to ref 19, "Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies" (J Am Acad Dermatol 2014;71:116-32).
- p. 3 Methods, Patients
the consensus criteria of the American Academy of Dermatology19
- p. 14 Reference 19
Guidelines of care for the manage-ment of atopic dermatitis: section 2. Man-agement and treatment of atopic dermati-tis with topical therapies
- p. 14 Reference 19
section 2. Man-agement and treatment of atopic dermati-tis with topical therapies
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that the AAD consensus diagnostic criteria appear in section 1 (diagnosis and assessment) of the AAD guideline series, not in section 2. The page 3 crop shows that the criteria sentence cites ref 19. The page 14 crop shows that ref 19 is section 2, on management with topical therapies. The title of the cited entry does not match the claim it supports. The authors should confirm the intended reference.
Second check: another model agreed
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2 minor (typos and the like; most checked by the judge only)
Wording The conclusion says dupilumab caused "clinically meaningful reductions in patient-reported symptoms of anxiety and depression", but the Table 1 footnote says that for HADS "the MCID for this scale has not been determined".
- p. 12 Discussion, concluding paragraph
causing clini-cally meaningful reductions in patient-reported symptoms of anxiety and depression
- p. 6 Table 1 footnote §§ (HADS)
the MCID for this scale has not been determined
Only the authors can say what is right here.
Judge's note: Page 12 (conclusion) has the quoted wording. The Table 1 footnote (upright page 6) gives MCIDs for EASI, SCORAD, POEM and DLQI but says none has been determined for HADS. Elsewhere, including the Discussion on page 12, the paper describes the HADS result only as a significantly greater reduction. So 'clinically meaningful' goes beyond the paper's own definition, and the authors should clarify it.
Second check: another model agreed
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Typo A Table 2 row label has a stray leading word: "Peak least-squares mean change from baseline in peak score on numerical rating scale for pruritus at wk 16".
- p. 8 Table 2, first row under Other secondary outcomes
Peak least-squares mean change from baseline in peak score on numerical rating scale for pruritus at wk 16
Judge's note: The upright page 8 image shows the row label beginning with 'Peak'. Every parallel row begins 'Least-squares mean ...'. The values (e.g., −2.03±0.21) are LS-mean changes at week 16, so the first 'Peak' is superfluous.
Second check: none (judge only)