Lokivetmab (anti-IL-31) for canine atopic dermatitis — LIKELY

In dogs with atopic dermatitis, does a single lokivetmab injection vs placebo reduce pruritus — and for how long?

Shelf #273 · gate-verified and displayed under the developer's blinded-trial rule

LIKELY: A single lokivetmab injection reduces pruritus in dogs with atopic dermatitis for at least a month at the higher doses tested, in a blinded, randomised, placebo-controlled dose-determination trial, and matches an established active drug in a second blinded trial. In Michels 2016 (211 client-owned dogs), lokivetmab 2 mg/kg gave a greater percentage reduction from baseline in owner-assessed pruritus (days 1–49) and clinician-assessed CADESI-03 scores (days 7–56) than placebo (P < 0.05), and the 0.5 and 2.0 mg/kg doses reduced pruritus vs placebo for at least 1 month, with level and duration of response increasing with dose. In Moyaert 2017 (274 dogs) — an active-comparator trial, not a placebo trial — monthly lokivetmab was noninferior to daily ciclosporin for pruritus reduction at day 28 (51.90% vs 43.72% reduction from baseline), while noninferiority for the CADESI-03 lesion score was not achieved (54.17 vs 56.86). Drafted Nov 10, 2026 (VetMed build, topic #273); all figures from abstracts fetched and verified at drafting.

Michels 2016: lokivetmab 2 mg/kg beat placebo on pruritus (days 1–49) and CADESI-03 (days 7–56) in 211 dogs

Blinded, randomised, placebo-controlled dose-determination trial (single injection, 56 days)

Who: Dogs: 211 client-owned dogs with a history of chronic atopic dermatitis, enrolled by clinicians at 15 referral clinics in a randomized, double blind, placebo-controlled trial — a single subcutaneous dose on day 0 of lokivetmab 0.125, 0.5 or 2.0 mg/kg, or placebo. Owners assessed pruritus on a visual analog scale on days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42, 49 and 56; clinicians assessed Canine AD Extent and Severity Index (CADESI-03) scores on days 0, 7, 14, 28, 42 and 56.

Result: Lokivetmab 2 mg/kg resulted in a greater percentage reduction from baseline in owner-assessed pruritus (days 1–49) and clinician-assessed CADESI-03 scores (days 7–56) compared with placebo (P < 0.05). Lower dose groups also differed from placebo, but later and for shorter durations: owner-assessed pruritus at 0.5 mg/kg on days 2–35 and at 0.125 mg/kg on days 7–21; CADESI-03 at 0.5 and 0.125 mg/kg on day 14. Lokivetmab at 0.5 and 2.0 mg/kg reduced pruritus compared with placebo for at least 1 month, and the level and duration of response increased with increasing dose.

Watch out: The record's abstract reports significance and duration but not the exact percentage magnitudes of the pruritus or lesion reductions, so this card claims direction, dose-response and duration — not a specific percentage effect. The record itself notes further studies are needed on variability in individual responses across a broader population.

Michels GM, Ramsey DS, Walsh KF, Martinon OM, Mahabir SP, Hoevers JD, Walters RR, Dunham SA. A blinded, randomized, placebo-controlled, dose determination trial of lokivetmab (ZTS-00103289), a caninized, anti-canine IL-31 monoclonal antibody in client owned dogs with atopic dermatitis. Vet Dermatol. 2016;27(6):478-e129. PMID: 27647569. Registry ID: none in the record. MeSH: Animals · Antibodies, Monoclonal · Dermatitis, Atopic · Dog Diseases · Dogs · Dose-Response Relationship, Drug · Double-Blind Method · Interleukins · Pruritus

Moyaert 2017: lokivetmab noninferior to ciclosporin for pruritus at day 28 (51.90% vs 43.72% reduction); lesion-score noninferiority not achieved

Blinded, randomised, active-comparator noninferiority trial vs ciclosporin (3 months, plus 6-month continuation)

Who: Dogs: 274 dogs with chronic atopic dermatitis enrolled from 40 practices in Belgium, The Netherlands, France and Germany, in a blinded, randomized clinical trial — randomised 1:1 to oral ciclosporin 5 mg/kg once daily or monthly injectable lokivetmab 1–3.3 mg/kg for three months; 81 animals completing the comparative phase entered a continuation phase on lokivetmab for a further six months. Owners assessed pruritus on a Visual Analog Scale; investigators assessed skin lesions with the CADESI-03 scale.

Result: Lokivetmab was noninferior to ciclosporin for pruritus reduction on day 28 (51.90% vs 43.72% percentage reduction from baseline). For day 28 CADESI-03 percentage reduction, noninferiority of lokivetmab (54.17) vs ciclosporin (56.86%) was not achieved, and at no time point were mean CADESI-03 scores significantly different between groups. In the continuation phase, 76.3% of animals (n = 45) were assessed as 'normal' for pruritus at study end. No abnormal health events associated with lokivetmab were observed in the three-month phase (142 dogs) or the six-month phase (81 dogs); the record notes a quick onset, within one day, at a minimum monthly dose of 1 mg/kg.

Watch out: The comparator is ciclosporin, not placebo — this trial corroborates lokivetmab against an established drug; it is not part of the placebo evidence, and this pack does not present it as such. Lesion-score noninferiority was not achieved at day 28 even though mean scores never differed significantly — both facts are on the face of the card.

Moyaert H, Van Brussel L, Borowski S, Escalada M, Mahabir SP, Walters RR, Stegemann MR. A blinded, randomized clinical trial evaluating the efficacy and safety of lokivetmab compared to ciclosporin in client-owned dogs with atopic dermatitis. Vet Dermatol. 2017;28(6):593-e145. PMID: 28906040. Registry ID: none in the record. MeSH: Animals · Antibodies, Monoclonal · Cyclosporine · Dermatitis, Atopic · Dog Diseases · Dogs · Female · Immunosuppressive Agents · Interleukins · Male

Synthesis: placebo-proven itch relief for at least a month per injection, corroborated against ciclosporin

Synthesis

Who: Synthesis of the cards above: Michels 2016 (blinded randomised placebo-controlled dose trial, 211 dogs) and Moyaert 2017 (blinded randomised trial vs ciclosporin, 274 dogs).

Result: The placebo-controlled trial establishes that lokivetmab works and that the effect is dose-dependent in level and duration, lasting at least a month at 0.5–2.0 mg/kg after a single injection. The second trial shows the monthly injection performing in the same range as daily ciclosporin for itch (noninferior at day 28), with the lesion-score noninferiority test formally missed. Together they support lokivetmab as a monthly injectable option whose best-proven effect is on pruritus, the hallmark sign of the disease.

Watch out: Both trials are manufacturer-programme studies; the placebo trial's abstract gives no exact effect percentages, which caps this shelf at LIKELY, and the active-comparator trial's missed lesion noninferiority is part of the balance, not a footnote.

Synthesis of Michels GM et al. PMID: 27647569; Moyaert H et al. PMID: 28906040. Registry IDs as on the individual cards.

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