Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study

Background ABP 501 is a biosimilar of adalimumab. Objective We sought to compare the efficacy and safety of ABP 501 with adalimumab. Methods This 52-week, double-blind study randomized patients with moderate to severe psoriasis to ABP 501 or adalimumab. At week 16, those with 50% or more improvement in Psoriasis Area and Severity Index score from baseline on ABP 501 continued the same treatment, whereas adalimumab-treated patients were rerandomized to adalimumab or ABP 501. Clinical similarity in Psoriasis Area and Severity Index percent improvement from baseline to week 16 (primary end point) was established if the point estimate of treatment difference and its 2-sided 95% confidence interval between groups was within equivalence margin of ±15. Patients, including those undergoing a single transition at week 16, were evaluated for safety and immunogenicity. Results Psoriasis Area and Severity Index percent improvement at week 16 was 80.9 for ABP 501 and 83.1 for adalimumab (least-square mean difference −2.18 [95% confidence interval −7.39 to 3.02]). Adverse events (67.2% [117/174] vs 63.6% [110/173]) and antidrug antibody incidence (55.2% [96/174] vs 63.6% [110/173]) for ABP 501 vs adalimumab were similar. Safety, including immunogenicity, was similar among groups after single transition (week 20). Limitations The 52-week data are not reported here. Conclusions ABP 501 was shown to be clinically similar to adalimumab. Safety and immunogenicity were not impacted immediately after single transition (adalimumab to ABP 501)

A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40 mg modified-release capsules versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea.

Randomized controlled studies of combination therapies in rosacea are limited.Evaluate efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40 mg modified-release capsules∗ (DMR) versus IVM and placebo (PBO) for treatment of severe rosacea.This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA]=4) to either IVM and DMR (combination arm) or IVM and PBO (monotherapy).A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs. -73.6% for monotherapy, p=0.032) and IGA score (p=0.032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving IGA 0 (11.9% vs. 5.1%, p=0.043)† and 100% lesion reduction (17.8% vs. 7.2%, p=0.006) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index and ocular signs/symptoms, and were well-tolerated.The duration of study prevented evaluation of potential recurrences or further improvements.Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in severe rosacea