Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment. J Rheumatol 2019;46:7–18.
In Table 1, Phase II, NCT01469013 is mentioned twice. The second occurrence is unnecessary.
In the Results section, page 9, last paragraph, the first sentence should read as follows: “The herpes zoster IR was significantly higher for 4 mg compared to placebo (4.3 vs 1.0) and was numerically higher for 4 mg compared to 2 mg in 2 mg-4 mg–extended.” Bold face indicates words added for clarity.
Table 4. Adverse events (AE) detail.
Three AE (EAIR ≥ 0.2) and their data have been added under the category “Temporary interruption because of AE ≥ 0.2 EAIR for 4 mg–treated patients in placebo-4 mg, n (EAIR).” See below.
Under the category “Permanent discontinuation because of AE ≥ 0.2 EAIR for 4 mg–treated patients in placebo-4 mg, n (EAIR),” in the row for infections and infestations, under the 2mg-4mg-extended set, for baricitinib 4 mg, the p value is < 0.05, indicating significance.
Table 5. The corrected table is below. Changes are indicated in bold face.
HDL numbers have been corrected.
Units for hemoglobin were corrected to g/dl.
Hemoglobin < 10 g/dl: the corrected values for baricitinib 2 mg and baricitinib 4 mg under the Placebo-2 mg–4 mg set are 33/462 (7.1) and 35/467 (7.5), respectively.
In the Placebo-4 mg set, under Baricitinib 4 mg, the corrected values for ALT ≥ 3× ULN are 15/987 (1.5), and for ALT ≥ 5× ULN, 7/988 (0.7).
Additional data.
Changes in selected laboratory values and clinical chemistry (weeks 0–24).a
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