Table 1 Human studies evaluating the efficacy and safety of LTP containing peach immunotherapy
First author, year, country | Study type/design | Study aim | Patient characteristics | Immunotherapy | Regimen | OFC | Immunological changes | Primary outcome/efficacy | Safety |
|---|---|---|---|---|---|---|---|---|---|
Beitia, 2021 [15] (Spain) | Prospective, open label | To describe the outcome of peach SLIT in LTP syndrome | 24 adults and five children treated with SLIT; 13 control individuals with LTP syndrome | SLIT with Pru p 3 | -4-day build-up cluster schedule until reaching a dose of 50 μg of Pru p 3 -Maintenance dose 12,5 μg/day of Pru p 3 for 3 years | -No entry OFC -single-blind OFC with unpeeled peach (145 g), was performed after 1 year. Patients who failed the first test repeat OFC after 6 months and 1 year | – | -16/22 patients continuing therapy for 3 years passed to OFC after 1 year -5/22 patients passed OFC within 2 years -4/29 patients discontinued therapy for poor compliance - 7/13 patients of control group have reaction with other foods -The severity of symptoms in the control group increased significantly (p < 0.001) | -21/29 patients with OAS in the first weeks of SLIT, self-resolved -3/29 patients discontinued immunotherapy due to adverse events |
Garcia-Gutierrez, 2021 [16] (Spain) | Case report | Try to stop the march of the LTP sensitization | A 46-year-old female with LTP syndrome reactive to hazelnut, mandarin, almond with contact dermatitis with peach | SLIT with Pru p 3 | -Rush schedule in 1 day -Maintenance dose 10 μg/day of Pru p 3 for 3 years | -No entry OFC - After 1-year single-blind OFC with peach (150 g) and mandarin 100 g) and aubergine (100 g) | After 2 years: -peach SPT decreased -total IgE increased -sIgE for Pru p 3 decreased - peach LTP IgG4 increased | -150 g of peach (1–1.2 mg of Pru p 3) tolerated after 1 year -100 g of aubergine and mandarin tolerated after 1 year -No other symptoms with other foods | No adverse reactions |
González Pérez, 2020 [17] (Spain) | Prospective, open label | To evaluate effectiveness of peach SLIT i in patients with other sensitizations | -18 patients (age 16–59 years) with LTP allergy including anaphylaxis -Presence of cofactors in 10 patients -17 patients with pollen rhinitis or asthma | SLIT with Pru p 3 | -Rapid 2-day schedule, for 2 patients with OAS 4-day initiation schedule | -No entry OFC -After 1 year single-Blind OFC with peach | After 3 years: -Pru p 3 IgE decreased -Pru p 3 IgG4 increased | -At exit OFC tolerance in all patients | - 2 patients with OAS during induction -No adverse reactions during maintenance |
Navarro, 2019 [18] (Spain), | Prospective, open label | To evaluate the effectiveness and safety of OIT with commercial peach juice | -24 patients (age 5–42 years) with a history of anaphylaxis in the previous 3 months -No control group | OIT with commercial fresh peach juice (Pru p 3 concentration is 21,16 μg/ml) | -1/1000 starting dose to 5 ml at visit 17 -Maintenance dose 200 ml/day, for 4 days/week | -No entry OFC -Single-blind OFC at visit 18 with peach juice (cumulative dose 200 ml) or a fresh peach | -Peach SPT decreased -No difference in SPT with LTP | -19/24 patients passed the OFC after 3.6 months | -No severe reaction -7/24 patients with mild oral symptoms -2/24 patients presented urticaria associated to cofactors -5 withdrew from study |
Moura, 2019 [19] (Portugal) | Retrospective, open label | To establish the safety of ultra-rush initiation protocol for peach SLIT | -15 patients (age 17–35 years) with a history of anaphylaxis with peach or other LTP foods -Presence of cofactors detected in 3 patients) | SLIT with Pru p 3 | -Standard protocol in 4 days (n = 5) and ultra-rush-protocol in 2 days (n = 10). Standard protocol reaches a cumulative dose of 78 μg, ultra-rush protocol 47 μg -Maintenance dose 10 μg/day | -no OFC | After 1 year: -sIgE for peach decreased in 8 patients and increased in 3 patients of ultra-rush group -sIgE for Pru p 3 decreased in 11 patients and increased in 3 patients of ultra-rush protocol and in 1 patient of standard protocol | -Ultra-rush-Protocol halved time to reach maintenance dose | -100% of patient in both groups with OAS during build-up phase -No systemic reaction -No increase of adverse reaction in ultra-rush-protocol -1 patient presented urticaria with exercise after ingestion of unpeeled apple after 1 year at the end of SLIT for 40 mouths |
Gomez, 2017 [20] (Spain) | Prospective, open label | To evaluate peach and peanut desensitization and immunologic responses at 1 year after SLIT | -48 patients (30.8 years, 25–35) with systemic reactions to peach and/or peanut -36 patients treated with Pru p 3 SLIT and 12 controls -12/36 patients with peanuts allergy | SLIT with Pru p 3 | -4-day build-up cluster schedule -Maintenance dose 200 μg of Pru p 3 for 1 year | -DBPCFC with 150 g of peach and 14 g of peanut was performed at T0 and after 12 month of SLIT -No DBPCFC in patients with 2 anaphylaxis episodes in the last 2 years | After 1 year: -SPT for peach and peanuts decreased in treated group -sIgE Pru p 3 and Ara h 9 decrease -sIgG4 for Pru p 3 and Ara h 9 increased -Basophil reactivity increased for Pru p 3 and Ara h 9 | -After 1 year increased threshold in OFC with peanut and peach in treated patients (p < 0.001) - 3/36 patients did not pass DBPCFC after 1 year -5 patients withdrew in the active group, in the placebo one | -25/36 with mild adverse reactions -In 91% of treated patients no reaction with peach after 1 year - No reaction after 1 years of Pru p 3 SLIT in 7/12 patients with peanut allergy |
Garcia, 2010 [21] (Spain) | RCT | -To evaluate the effect of peach SLIT to IgE levels to Rosaceae allergens, -To monitor new-Sensitization to Rosaceae or pollen | -56 peach allergic adult patients (18–65 years) randomized 2:1 to receive SLIT with peach or placebo for 6 months -21 patients with systemic reaction (mainly sensitized to Pru p 3) -Sensitization to Mal d 1 in 18.5%, Mal d 4 24.1% at baseline | SLIT with peach peel extract (Pru p 3 quantified). Pru p 1 and profilin also present | Same protocol as adopted in Fernandez-Rivas (14 | DBPCFC with lyophilized peach peelings at T0 and after 6 months of SLIT (cumulative dose of Pru p 3 is 3249 μg, about 1,5 peaches) | - Peach SPT decreased in active group -sIgE for Pru p 3 increased in both groups | -IgE to Pru p 3 increased at 1 month in both active and placebo group but remained stable only in active group at 6 months -IgE to other allergens unchanged; no new sensitization detected -SPT to peach decreased in active group and were lower than controls at 6 months | / |
Pereira, 2009 [22] (Spain) | Case report | To evaluate efficacy and safety of SLIT | -A 40 year-old female with LTP syndrome | SLIT with Pru p 3 (concentraction of 40 μg/ml) | -Ultra-rush -protocol in 1 day -Maintenance dose of 10 μg/day for 5 days/week for 1 year | -DBPCFC with peach at T0 and after 4, 8 and 12 months after starting SLIT -OFC performed with 150 g of peach | -Pru p 3 SPT decreased -No change for Pru p 3 IgE, IgG, IgG1 and IgG4 | - Negative OFC after 4 months - After 3 months of non-diet restriction for vegetable, only nuts and pepper were excluded by diet | - OAS during build-up -No adverse reaction during maintenance doses |
Fernandez-Rivas, 2009 [14] (Spain) | -RCT | -To evaluate the change in response to DBPCFC with peach | -56 adults (18–65 years) with peach allergy randomized 2:1 to receive SLIT with peach or placebo for 6 months | SLIT with Pru p 3 | -rush- protocol (until 50 µg of Pru p 3) -Maintenance dose of 10 μg/day for 3 days at week for 6 months | DBPCFC with lyophilized peach peelings at T0 and after 6 months of SLIT (cumulative dose of Pru p 3 is 3249 μg, about 1,5 peaches) | -Pru p 3 SPT decreased in treatment patients -Pru p 3 sIgE increased in active and placebo arms -Pru p 3 IgG4 increased in active arm | -Active group tolerated a 3 to ninefold higher amount of peach, presented a 5.3 times decrease in Pru p 3 SPT and an IgG4 increase | -in 13/44 patients and 12 control side effects (OAS, gastrointestinal symptoms, urticaria and itching, rhinitis) -No serious effect reported |