Icotyde Drug Information
Generic name: ICOTROKINRA
Uses of Icotyde
ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.
Dosage & Administration of Icotyde
Recommended Evaluation and Immunizations Prior to Treatment Initiation Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment. Complete all age-appropriate vaccinations according to current immunization guidelines.
Recommended Dosage and Administration Instructions
The recommended dosage of ICOTYDE is 200 mg administered orally once daily. Administer ICOTYDE upon waking on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.
Swallow ICOTYDE whole. Do not crush, split, or chew tablets. If a patient misses a dose, instruct patients to take the missed dose as soon as possible with a return to normal dosing schedule the following day.
Alternative Preparation and Administration Instructions for Patients Who Have Difficulty Swallowing Tablets ICOTYDE 200 mg tablet can also be dispersed in water using the following instructions: Place one ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water. It may take a few minutes for the tablet to disperse. The tablet may not completely disperse.
The mixture may look yellow, milky, or cloudy, and small pieces may be seen in the water which are safe to swallow. Gently swirl the cup before drinking and swallowing the full mixture. Add at least 120 mL (4 ounces) of additional water to the cup and completely swallow the contents to make sure the whole dose is taken.
Complete administration of ICOTYDE within 15 minutes of dispersion in water.
Side Effects of Icotyde
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ICOTYDE was evaluated in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4) and two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2). Of these, 648 subjects were treated with ICOTYDE for at least one year.
Data from these four trials were pooled to evaluate the safety of ICOTYDE compared to placebo for 16 weeks. Adverse Reactions Weeks 0 to 16 Table 1: Adverse Reactions that Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently than in the Placebo Group in Trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16 percentages based on Cochran-Mantel-Haenszel (CMH) adjusted proportions. 15 3 Adverse reactions that occurred in < 1% of subjects in the ICOTYDE group and at a higher rate than in the placebo group through Week 16 in Trials PSO-1, PSO-2, PSO-3, and PSO-4 were: gastritis, abdominal discomfort, and one fatal case involving upper gastrointestinal bleeding in a subject with underlying risk factors. A relationship of this event to ICOTYDE is not established.
Adverse Reactions in Pediatric Subjects 12 Years of Age and Older The safety of ICOTYDE was evaluated in pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4). A total of 72 pediatric subjects were treated with ICOTYDE 200 mg orally once daily. The adverse reactions observed in pediatric subjects were consistent with the most common adverse reactions (≥ 1%) observed in the overall population.
| Adverse Reactions | ICOTYDE N=1296 n (%) | Placebo N=568 n (%) |
|---|---|---|
| Headache | 51 (4.1) | 19 (3.3) |
| Nausea | 15 (1.2) | 3 (0.5) |
| Cough | 15 (1.2) | 1 (0.2) |
| Fungal Infection Fungal infection includes tinea pedis (n=4), tinea versicolor (n=2), oral candidiasis (n=2), onychomycosis (n=1), skin candida (n=1), urinary tract candidiasis (n=1), vulvovaginal candidiasis (n=1), fungal skin infection (n=1), genital infection fungal (n=1), ear infection fungal (n=1), laryngitis fungal (n=1). Two subjects experienced more than 1 event. | 14 (1.1) | 0 (0) |
| Fatigue | 15 (1.0) | 3 (0.5) |
Warnings & Cautions for Icotyde
Infections Medicines that interact with the immune system may increase the risk of infection. In the 16-week placebo-controlled trials in subjects with moderate-to-severe plaque psoriasis, the rate of serious infections for ICOTYDE-treated subjects was 0.2% compared to 0.4% of subjects who received placebo. Avoid treatment with ICOTYDE in patients with any clinically important active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ICOTYDE. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection and/or is not responding to standard therapy, monitor the patient closely and discontinue ICOTYDE until the infection resolves.
Tuberculosis
Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment. Consider anti-TB therapy prior to initiating ICOTYDE in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after ICOTYDE treatment.
Avoid administering ICOTYDE to patients with active TB.
Immunizations
Avoid use of live vaccines in patients during treatment with ICOTYDE. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ICOTYDE, complete immunizations according to current immunization guidelines.
No data are available on the response to live or inactive vaccines.
Pregnancy Safety for Icotyde
Pregnancy Risk Summary The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal reproduction study in rabbits, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively. There is a pregnancy safety study for ICOTYDE.
If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com. Data Animal Data In an embryo-fetal development study, icotrokinra was administered to pregnant rats during the period of organogenesis at oral doses of 70, 200, and 1000 mg/kg/day. No maternal or embryo-fetal toxicity was observed at doses up to 1000 mg/kg/day (297 times the MRHD based on AUC comparison).
In another embryo-fetal development study, icotrokinra was administered to pregnant rabbits during the period of organogenesis at oral doses of 50, 200, and 500 mg/kg/day. Maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs were observed at 500 mg/kg/day (157 times the MRHD based on AUC comparison). No maternal or embryo-fetal toxicity was noted at doses up to 200 mg/kg/day in rabbits (27 times the MRHD based on AUC comparison).
In a pre- and post-natal development study in rats, icotrokinra was administered to pregnant rats during pregnancy and lactation periods at oral doses of 20, 70, and 200 mg/kg/day.
Pediatric Use of Icotyde
Pediatric Use The safety and effectiveness of ICOTYDE have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Use of ICOTYDE for this indication is supported by evidence from two multi-center, randomized 52-week trials (Trial PSO-3 and Trial PSO-4) conducted in adults and pediatric subjects, including 72 pediatric subjects 12 years of age and older treated with ICOTYDE. The safety and effectiveness of ICOTYDE in pediatric patients younger than 12 years of age or who weigh less than 40 kg have not been established.
Clinical Studies of Icotyde
The efficacy of ICOTYDE was evaluated in four multi-center, randomized, double-blind, placebo and/or active comparator-controlled trials (Trial PSO-1, Trial PSO-2, Trial PSO-3, and Trial PSO-4 ) that included 2500 subjects (2428 adults and 72 pediatric subjects 12 years and older who weigh at least 40 kg) with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Adults with Moderate-to-Severe Plaque Psoriasis (Trials PSO-1 and PSO-2) Trial Design Trial PSO-1 and Trial PSO-2 enrolled 1505 adults with moderate-to-severe plaque psoriasis defined as Investigator's Global Assessment (IGA) score ≥3, a Psoriasis Area and Severity Index (PASI) score ≥12, and body surface area (BSA) involvement ≥10%. Subjects were randomized to either ICOTYDE 200 mg orally once daily, deucravacitinib 6 mg orally once daily or placebo.
At Week 16, subjects originally randomized to placebo received ICOTYDE 200 mg orally once daily thereafter. At Week 24, subjects originally randomized to deucravacitinib received ICOTYDE 200 mg orally once daily thereafter. Baseline Characteristics Baseline characteristics were consistent across both trials.
At baseline, subjects had a median affected BSA of 21%, a median PASI score of 18, and 14% had a history of psoriatic arthritis. The proportion of subjects with a baseline IGA score of 4 (severe) was 20%. At baseline, 72% had received prior systemic therapy, 33% of subjects had received prior phototherapy, and 26% had received prior biologic therapy.
Clinical Response Trial PSO-1 and Trial PSO-2 assessed responses at Week 16 for ICOTYDE compared to placebo for two co-primary endpoints: the proportion of subjects who achieved IGA 0/1 response (defined as IGA score of 0 or 1 with a ≥2-grade improvement from baseline) the proportion of subjects who achieved at least a 90% improvement in PASI scores from baseline (PASI 90). Other evaluated outcomes for ICOTYDE compared to placebo included IGA 0, PASI 75, PASI 100, Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0, and PSSD Itch Score improvement from baseline (≥4-point reduction). Tables 2 and 3 present the efficacy results in adults with moderate-to-severe plaque psoriasis for Trial PSO-1 and Trial PSO-2.
Subjects were randomized to receive either ICOTYDE (200 mg orally once daily) or placebo for 16 weeks. At baseline, subjects had a median affected BSA of 20%, a median PASI score of 17, and 13% had a history of psoriatic arthritis. At baseline, 72% had prior systemic treatment, 30% of subjects had received prior phototherapy, and 34% had received prior biologic therapy.
Table 4 presents the efficacy results in adults and pediatric subjects 12 years of age and older for Trial PSO-3. Table 5 presents the efficacy results in pediatric subjects 12 years of age and older at Week 16 enrolled in Trial PSO-3. Additionally, subjects in Trial PSO-4 had at least one of the following baseline conditions: ss-IGA score ≥3 (at least moderate plaque psoriasis of the scalp), static Physician's Global Assessment of Genitalia (sPGA-G) score ≥3 (at least moderate plaque psoriasis of the genital area), and/or Physician's Global Assessment of Hands and/or Feet (hf-PGA) score ≥3 (at least moderate plaque psoriasis of the hands and/or feet).
At Week 16, subjects originally randomized to placebo switched to receive ICOTYDE 200 mg orally once daily, and subjects randomized to ICOTYDE at baseline remained on treatment through the end of study. The proportion of subjects with affected BSA less than 10% was 36% with a median affected BSA of 12%. The proportion of subjects with ss-IGA score of 3 or greater was 81%.
The proportion of subjects with sPGA-G score of 3 or greater was 45%. The proportion of subjects with hf-PGA score of 3 or greater was 23%. Scalp, genital and hand/foot subpopulations were not mutually exclusive.
At baseline, 73% had received prior systemic therapy, 39% of subjects had received prior phototherapy, and 33% had received prior biologic therapy. Clinical Response In Trial PSO-4, the primary endpoint was the proportion of subjects who achieved an IGA 0/1 response (defined as IGA score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16). Other secondary endpoints at Week 16 included proportion of subjects who achieved ss-IGA score of 0 (absence of disease) or 1 (very mild disease), Psoriasis Scalp Severity Index (PSSI) 90, improvement in scalp itch as measured by Scalp Itch Numerical Rating Scale (NRS) Score, sPGA-G score of 0 (clear) or 1 (minimal), improvement of genital itch severity as measured by a reduction of at least 4 points in the 11-point Genital Psoriasis Symptoms Scale (GPSS) Genital Itch NRS Score, and the patient-perceived impact of psoriasis of the genital area on limiting frequency of sexual activity (intercourse or other activities) as measured by the Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2.
Table 6: Efficacy Results in Adults and Pediatric Subjects 12 Years of Age and Older with Moderate-to-Severe Plaque Psoriasis of the Scalp or Genital Area at 9 43 Subgroup Analyses of Trials PSO-1, PSO-2, PSO-3 and PSO-4 An examination of age, gender, race, body weight, baseline disease severity, and previous treatment with systemic or biologic agents did not identify differences in response to ICOTYDE among these subgroups.
| Endpoint | ICOTYDE (N=311) n (%) | Placebo (N=156) n (%) | Deucravacitinib (N=307) n (%) | Difference, % (95% CI) | |
|---|---|---|---|---|---|
| Difference from Placebo | Difference from Deucravacitinib | ||||
| CI = Confidence interval; PASI = Psoriasis Area and Severity Index; IGA = Investigator's Global Assessment; PSSD = Psoriasis Symptoms and Signs Diary | |||||
| IGA 0 or 1 ("cleared" or "minimal") and a ≥2-grade improvement from baseline) | |||||
| Week 16 Co-primary endpoints comparing ICOTYDE to placebo. | 213 (68) | 17 (11) | 154 (50) | 58 (50, 64) | 18 (11, 26) |
| Week 24 | 230 (74) | - | 161 (52) | - | 22 (14, 29) |
| IGA 0 ("cleared") | |||||
| Week 16 | 114 (37) | 3 (2) | 48 (16) | 35 (29, 41) | 21 (14, 28) |
| Week 24 | 150 (48) | - | 63 (21) | - | 28 (21, 35) |
| PASI 75 | |||||
| Week 16 | 231 (74) | 18 (12) | 176 (57) | 63 (55, 69) | 17 (10, 24) |
| Week 24 | 254 (82) | - | 196 (64) | - | 18 (11, 25) |
| PASI 90 | |||||
| Week 16 | 171 (55) | 6 (4) | 91 (30) | 51 (44, 57) | 25 (18, 33) |
| Week 24 | 205 (66) | - | 127 (41) | - | 25 (17, 32) |
| PASI 100 | |||||
| Week 16 | 97 (31) | 2 (1) | 34 (11) | 30 (24, 36) | 20 (14, 26) |
| Week 24 | 129 (41) | - | 49 (16) | - | 26 (19, 32) |
| PSSD Symptom Score 0 Includes subjects with baseline PSSD Symptom Score >0. | |||||
| N | 286 | 142 | 272 | - | - |
| Week 16 | 68 (24) | 4 (3) | 25 (9) | 21 (15, 27) | 14 (8, 21) |
| PSSD Itch Score Improvement (≥4-point reduction from baseline) Includes subjects with baseline PSSD Itch Score ≥4. | |||||
| N | 251 | 115 | - | - | - |
| Week 4 | 56 (22) | 8 (7) | - | 15 (8, 22) | - |
| Week 16 | 155 (62) | 19 (17) | - | 45 (35, 54) | - |
| Endpoint | ICOTYDE (N=320) n (%) | Placebo (N=81) n (%) | Deucravacitinib (N=322) n (%) | Difference, % (95% CI) | |
|---|---|---|---|---|---|
| Difference from Placebo | Difference from Deucravacitinib | ||||
| CI = Confidence interval; PASI = Psoriasis Area and Severity Index; IGA = Investigator's Global Assessment; PSSD = Psoriasis Symptoms and Signs Diary Trial PSO-2 enrolled 731 subjects, of which 723 subjects were evaluable for efficacy. | |||||
| IGA 0 or 1 ("cleared" or "minimal") and a ≥2-grade improvement from baseline | |||||
| Week 16 Co-primary endpoints comparing ICOTYDE to placebo. | 227 (71) | 7 (9) | 177 (55) | 63 (53, 70) | 16 (9, 23) |
| Week 24 | 220 (69) | - | 179 (56) | - | 13 (6, 21) |
| IGA 0 ("cleared") | |||||
| Week 16 | 118 (37) | 1 (1) | 57 (18) | 36 (29, 42) | 19 (13, 26) |
| Week 24 | 128 (40) | - | 68 (21) | - | 19 (12, 26) |
| PASI 75 | |||||
| Week 16 | 249 (78) | 8 (10) | 198 (61) | 68 (59, 75) | 17 (10, 23) |
| Week 24 | 265 (83) | - | 216 (67) | - | 16 (9, 22) |
| PASI 90 | |||||
| Week 16 | 184 (58) | 1 (1) | 111 (34) | 57 (49, 62) | 23 (16, 30) |
| Week 24 | 208 (65) | - | 141 (44) | - | 21 (14, 29) |
| PASI 100 | |||||
| Week 16 | 102 (32) | 1 (1) | 46 (14) | 31 (24, 36) | 18 (11, 24) |
| Week 24 | 107 (33) | - | 52 (16) | - | 17 (11, 24) |
| PSSD Symptom Score 0 Includes subjects with baseline PSSD Symptom Score >0. | |||||
| N | 296 | 70 | 282 | - | - |
| Week 16 | 64 (22) | 0 | 36 (13) | 22 (15, 27) | 9 (3, 15) |
| PSSD Itch Score Improvement (≥4-point reduction from baseline) Includes subjects with baseline PSSD Itch Score ≥4. | |||||
| N | 256 | 60 | - | - | - |
| Week 4 | 54 (21) | 3 (5) | - | 16 (6, 22) | - |
| Week 16 | 154 (60) | 9 (15) | - | 46 (34, 56) | - |
| Endpoint | ICOTYDE (N=456) n (%) | Placebo (N=228) n (%) | Difference, % from Placebo (95% CI) |
|---|---|---|---|
| CI = Confidence interval; PASI = Psoriasis Area and Severity Index; IGA = Investigator's Global Assessment; PSSD = Psoriasis Symptoms and Signs Diary | |||
| IGA 0 or 1 ("cleared" or "minimal") and a ≥2-grade improvement from baseline | |||
| Week 16 Co-primary endpoints comparing ICOTYDE to placebo. | 295 (65) | 19 (8) | 56 (50, 62) |
| IGA 0 ("cleared") | |||
| Week 16 | 152 (33) | 3 (1) | 32 (27, 37) |
| PASI 75 | |||
| Week 16 | 315 (69) | 25 (11) | 58 (52, 64) |
| PASI 90 | |||
| Week 16 | 226 (50) | 10 (4) | 45 (40, 50) |
| PASI 100 | |||
| Week 16 | 123 (27) | 1 (<1) | 26 (22, 31) |
| PSSD Symptom Score 0 Includes subjects with baseline PSSD Symptom Score >0. | |||
| N | 408 | 208 | - |
| Week 16 | 82 (20) | 2 (<1) | 19 (15, 24) |
| PSSD Itch Score Improvement (≥4-point reduction from baseline) Includes subjects with baseline PSSD Itch Score ≥4. | |||
| N | 350 | 176 | - |
| Week 4 | 67 (19) | 9 (5) | 14 (9, 19) |
| Week 16 | 203 (58) | 23 (13) | 45 (37, 52) |
| Endpoint | ICOTYDE n (%) | Placebo n (%) | Difference, % from Placebo (95% CI) |
|---|---|---|---|
| CI = Confidence interval; PASI = Psoriasis Area and Severity Index; IGA = Investigator's Global Assessment | |||
| Number of randomized pediatric subjects | 44 | 22 | - |
| IGA 0 or 1 ("cleared" or "minimal") and a ≥2-grade improvement from baseline | 37 (84) | 6 (27) | 56 (33, 74) |
| PASI 90 | 31 (70) | 3 (14) | 56 (33, 73) |
| Endpoint | ICOTYDE n (%) | Placebo n (%) | Difference, % from Placebo (95% CI) |
|---|---|---|---|
| CI = Confidence interval; IGA = Investigator's Global Assessment; ss-IGA = Scalp-specific Investigator Global Assessment; PSSI = Psoriasis Scalp Severity Index; NRS = Numerical Rating Scale; sPGA-G = Static Physician's Global Assessment of Genitalia; GPSS = Genital Psoriasis Symptoms Scale; GenPs-SFQ = Genital Psoriasis Sexual Frequency Questionnaire | |||
| Number of randomized subjects | 208 | 103 | - |
| IGA 0 or 1 ("cleared" or "minimal") and a ≥2-grade improvement from baseline Primary endpoint comparing ICOTYDE to placebo. | 118 (57) | 6 (6) | 51 (42, 59) |
| Number of subjects with baseline ss-IGA score of ≥3 | 167 | 85 | - |
| ss-IGA 0 or 1 ("absence of disease" or "very mild disease") (scalp) | 110 (66) | 9 (11) | 56 (45, 64) |
| PSSI 90 | 96 (57) | 5 (6) | 52 (42, 60) |
| Number of subjects with baseline Scalp Itch NRS score ≥4 and baseline ss-IGA score ≥3 | 131 | 58 | - |
| Scalp Itch NRS score (≥4-point improvement) | 77 (59) | 5 (9) | 50 (38, 61) |
| Number of subjects with baseline sPGA-G score of ≥3 | 98 | 42 | - |
| sPGA-G 0 or 1 ("clear" or "minimal") (genitalia) | 75 (77) | 9 (21) | 55 (39, 68) |
| Number of subjects with baseline GPSS Genital Itch NRS score ≥4 and baseline sPGA-G score ≥3 | 69 | 31 | - |
| GPSS Genital Itch NRS score (≥4-point improvement) | 44 (64) | 4 (13) | 50 (31, 64) |
| Number of subjects with baseline GenPs-SFQ Item 2 score ≥2 and baseline sPGA-G score ≥3 | 55 | 25 | - |
| GenPs-SFQ Item 2 score 0 or 1 ("never" or "rarely") (genitalia) | 44 (80) | 9 (36) | 43 (20, 62) |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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