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Impact of previous biologic use on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis: integrated analysis of the randomized controlled trials AMAGINE-2 and AMAGINE-3.
Br J Dermatol. 2018 08; 179(2):320-328.BJ

Abstract

BACKGROUND

Biologics are being used increasingly to treat moderate-to-severe psoriasis. Efficacy may differ in patients with previous exposure to biologics.

OBJECTIVES

To investigate the impact of previous biologic exposure on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis.

METHODS

Two placebo- and ustekinumab-controlled phase III clinical trials. There was an initial 12-week induction phase where patients were treated with brodalumab [210 mg or 140 mg every 2 weeks (Q2W)], ustekinumab or placebo. Efficacy end points included ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (score of 0 or 1) vs. placebo, PASI 100 vs. ustekinumab, Dermatology Life Quality Index and Psoriasis Symptom Inventory. Adverse events were monitored throughout.

RESULTS

In total, 493 patients [334 (27%) brodalumab 210 mg Q2W and 159 (26%) ustekinumab] had received prior biologics; 150 (12%) and 62 (10%), respectively, reported previously failed treatment with a biologic. Brodalumab efficacy in patients with or without previous exposure to biologics was statistically equivalent: 40·9% and 39·5% of biologic-naive and -experienced patients achieved PASI 100 at week 12, compared with 21·1% and 17·0% with ustekinumab (both P < 0·001). In patients where prior biologics had been successful or failed, 41·7% and 32·0% achieved PASI 100, compared with 21·1% and 11·3% with ustekinumab. Tolerability was similar, and did not appear to be influenced by previous treatment with biologics.

CONCLUSIONS

The efficacy of brodalumab 210 mg Q2W was similar regardless of prior biological therapy (P = 0·31, 0·32 and 0·64 for PASI 75, 90 and 100, respectively). Almost twice as many patients achieved PASI 100 or complete clearance with brodalumab at week 12 compared with ustekinumab; the differences were most noticeable where previous biologics had failed. Both treatments were well tolerated.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Papp KA
Probity Medical Research, Waterloo, ON, Canada.
Gordon KB
Medical College of Wisconsin, Milwaukee, WI, U.S.A.
Langley RG
Dalhousie University, Halifax, NS, Canada.
Lebwohl MG
Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A.
Gottlieb AB
Department of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY, U.S.A.
Rastogi S
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, U.S.A.
Pillai R
Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals North America, LLC), Petaluma, CA, U.S.A.
Israel RJ
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, U.S.A.

MeSH

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiological ProductsDrug SubstitutionFemaleHumansMaleMiddle AgedPsoriasisSeverity of Illness IndexTreatment OutcomeUstekinumab

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29488226

Citation

Papp, K A., et al. "Impact of Previous Biologic Use On the Efficacy and Safety of Brodalumab and Ustekinumab in Patients With Moderate-to-severe Plaque Psoriasis: Integrated Analysis of the Randomized Controlled Trials AMAGINE-2 and AMAGINE-3." The British Journal of Dermatology, vol. 179, no. 2, 2018, pp. 320-328.
Papp KA, Gordon KB, Langley RG, et al. Impact of previous biologic use on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis: integrated analysis of the randomized controlled trials AMAGINE-2 and AMAGINE-3. Br J Dermatol. 2018;179(2):320-328.
Papp, K. A., Gordon, K. B., Langley, R. G., Lebwohl, M. G., Gottlieb, A. B., Rastogi, S., Pillai, R., & Israel, R. J. (2018). Impact of previous biologic use on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis: integrated analysis of the randomized controlled trials AMAGINE-2 and AMAGINE-3. The British Journal of Dermatology, 179(2), 320-328. https://doi.org/10.1111/bjd.16464
Papp KA, et al. Impact of Previous Biologic Use On the Efficacy and Safety of Brodalumab and Ustekinumab in Patients With Moderate-to-severe Plaque Psoriasis: Integrated Analysis of the Randomized Controlled Trials AMAGINE-2 and AMAGINE-3. Br J Dermatol. 2018;179(2):320-328. PubMed PMID: 29488226.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of previous biologic use on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis: integrated analysis of the randomized controlled trials AMAGINE-2 and AMAGINE-3. AU - Papp,K A, AU - Gordon,K B, AU - Langley,R G, AU - Lebwohl,M G, AU - Gottlieb,A B, AU - Rastogi,S, AU - Pillai,R, AU - Israel,R J, Y1 - 2018/05/23/ PY - 2018/02/08/accepted PY - 2018/3/1/pubmed PY - 2019/10/28/medline PY - 2018/3/1/entrez SP - 320 EP - 328 JF - The British journal of dermatology JO - Br J Dermatol VL - 179 IS - 2 N2 - BACKGROUND: Biologics are being used increasingly to treat moderate-to-severe psoriasis. Efficacy may differ in patients with previous exposure to biologics. OBJECTIVES: To investigate the impact of previous biologic exposure on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis. METHODS: Two placebo- and ustekinumab-controlled phase III clinical trials. There was an initial 12-week induction phase where patients were treated with brodalumab [210 mg or 140 mg every 2 weeks (Q2W)], ustekinumab or placebo. Efficacy end points included ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (score of 0 or 1) vs. placebo, PASI 100 vs. ustekinumab, Dermatology Life Quality Index and Psoriasis Symptom Inventory. Adverse events were monitored throughout. RESULTS: In total, 493 patients [334 (27%) brodalumab 210 mg Q2W and 159 (26%) ustekinumab] had received prior biologics; 150 (12%) and 62 (10%), respectively, reported previously failed treatment with a biologic. Brodalumab efficacy in patients with or without previous exposure to biologics was statistically equivalent: 40·9% and 39·5% of biologic-naive and -experienced patients achieved PASI 100 at week 12, compared with 21·1% and 17·0% with ustekinumab (both P < 0·001). In patients where prior biologics had been successful or failed, 41·7% and 32·0% achieved PASI 100, compared with 21·1% and 11·3% with ustekinumab. Tolerability was similar, and did not appear to be influenced by previous treatment with biologics. CONCLUSIONS: The efficacy of brodalumab 210 mg Q2W was similar regardless of prior biological therapy (P = 0·31, 0·32 and 0·64 for PASI 75, 90 and 100, respectively). Almost twice as many patients achieved PASI 100 or complete clearance with brodalumab at week 12 compared with ustekinumab; the differences were most noticeable where previous biologics had failed. Both treatments were well tolerated. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/29488226/Impact_of_previous_biologic_use_on_the_efficacy_and_safety_of_brodalumab_and_ustekinumab_in_patients_with_moderate_to_severe_plaque_psoriasis:_integrated_analysis_of_the_randomized_controlled_trials_AMAGINE_2_and_AMAGINE_3_ DB - PRIME DP - Unbound Medicine ER -