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近日，新基（Celgene）口服药物OTEZLA(APREMILAST)TABLET ORAL获FDA批准，用于适合光疗和系统疗法的中度至重度斑块型银屑病（Plaque Psoriasis）成人患者的治疗。Otezla是一种口服、选择性磷酸二酯酶4（PDE4）抑制剂，该药是FDA批准的首个也是唯一一个用于斑块型银屑病治疗的PDE4抑制剂。
2.2 Dosage Adjustment in Patients with Severe Renal Impairment OTEZLA dosage should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance (CLcr) of less than 30 mL per minute estimated by the Cockcroft–Gault equation) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. For initial dosage titration in this group, it is recommended that OTEZLA be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped. 3 DOSAGE FORMS AND STRENGTHS OTEZLA is available as diamond shaped, film coated tablets in the following dosage strengths: 10-mg pink tablet engraved with “APR” on one side and “10” on the other side 20-mg brown tablet engraved with “APR” on one side and “20” on the other side 30-mg beige tablet engraved with “APR” on one side and “30” on the other side. 4 CONTRAINDICATIONS OTEZLA is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Adverse Reactions (6.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Depression Treatment with OTEZLA is associated with an increase in adverse reactions of depression. Before using OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment with OTEZLA in such patients. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with OTEZLA if such events occur. Psoriatic arthritis: During the 0 to 16 week placebo-controlled period of the 3 controlled clinical trials, 1.0% (10/998) of subjects treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. During the clinical trials, 0.3% (4/1441) of subjects treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated subjects (0/495). Depression was reported as serious in 0.2% (3/1441) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/495). Instances of suicidal ideation and behavior have been observed in 0.2% (3/1441) of subjects while receiving OTEZLA, compared to none in placebo treated subjects (0/495). In the clinical trials, 2 subjects who received placebo committed suicide compared to none in OTEZLA-treated subjects. Psoriasis: During the 0 to 16 week placebo-controlled period of the 3 controlled clinical trials, 1.3% (12/920) of subjects treated with OTEZLA reported depression compared to 0.4% (2/506) treated with placebo. During the clinical trials, 0.1% (1/1308) of subjects treated with OTEZLA discontinued treatment due to depression compared with none in placebo-treated subjects(0/506). Depression was reported as serious in 0.1% (1/1308) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/506). Instances of suicidal behavior have been observed in 0.1% (1/1308) of subjects while receiving OTEZLA, compared to 0.2% (1/506) in placebo-treated subjects. In the clinical trials, one subject treated with OTEZLA attempted suicide while one who received placebo committed suicide. 5.2 Weight Decrease During the controlled period of the studies in psoriatic arthritis (PsA), weight decrease between 5%-10% of body weight was reported in 10% (49/497) of subjects treated with OTEZLA 30 mg twice daily compared to 3.3% (16/495) treated with placebo [see Adverse Reactions (6.1)]. During the controlled period of the trials in psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (96/784) of subjects treated with OTEZLA compared to 5% (19/382) treated with placebo. Weight decrease of ≥10% of body weight occurred in 2% (16/784) of subjects treated with OTEZLA 30 mg twice daily compared to 1% (3/382) subjects treated with placebo. Patients treated with OTEZLA should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of OTEZLA should be considered. 5.3 Drug Interactions Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of OTEZLA. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA is not recommended [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. 6 ADVERSE REACTIONS 6.1 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 clinical practice. Psoriatic Arthritis Clinical Trials OTEZLA was evaluated in 3 multicenter, randomized, double-blind, placebo-controlled trials [Studies PsA-1, PsA-2, and PsA-3] of similar design in adult patients with active psoriatic arthritis [see Clinical Studies (14.1)]. Across the 3 studies, there were 1493 patients randomized equally to placebo, OTEZLA 20 mg twice daily or OTEZLA 30 mg twice daily. Titration was used over the first 5 days [see Dosage and Administration (2.1)]. Placebo patients whose tender and swollen joint counts had not improved by at least 20% were re-randomized 1:1 in a blinded fashion to either OTEZLA 20 mg twice daily or 30 mg twice daily at week 16 while OTEZLA patients remained on their initial treatment. Patients ranged in age from 18 to 83 years, with an overall median age of 51 years. The majority of the most common adverse reactions presented in Table 2 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for patients taking OTEZLA were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of patients with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for patients taking OTEZLA 30 mg twice daily and 1.2% for placebo-treated patients. Table 2: Adverse Reactions Reported in ≥2% of Patients on OTEZLA 30 mg Twice Daily and ≥1% Than That Observed in Patients on Placebo for up to Day 112 (Week 16)
b Of the reported adverse drug reactions none were serious. c n (%) indicates number of patients and percent. Other adverse reactions reported in patients on OTEZLA in clinical studies including extension studies: Immune system disorders: Hypersensitivity Investigations: Weight decrease Gastrointestinal Disorders: Frequent bowel movement, gastroesophageal reflux disease, dyspepsia Metabolism and Nutrition Disorders: Decreased appetite* Nervous System Disorders: Migraine Respiratory, Thoracic, and Mediastinal Disorders: Cough Skin and Subcutaneous Tissue Disorders: Rash 1 patient treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction. Psoriasis Clinical Trials The safety of OTEZLA® was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days [see Dosage and Administration (2.1)]. Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years. Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of subjects with psoriasis who discontinued treatment due to any adverse reaction was 6.1% for subjects treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated subjects. Table 3: Adverse Reactions Reported in ≥1% of Subjects on OTEZLA and With Greater Frequency Than in Subjects on Placebo; up to Day 112 (Week 16)
Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) subjects following discontinuation of treatment with OTEZLA. 7 DRUG INTERACTIONS 7.1 Strong CYP450 Inducers Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers (such as rifampin) and may result in loss of efficacy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OTEZLA during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972. Risk Summary Adequate and well-controlled studies with OTEZLA have not been conducted in pregnant women. In animal embryo-fetal development studies, the administration of apremilast to cynomolgus monkeys during organogenesis resulted in dose-related increases in abortion/embryo-fetal death at dose exposures 2.1-times the maximum recommended human therapeutic dose (MRHD) and no adverse effect at an exposure of 1.4-times the MRHD. In mice, there were no apremilast induced malformations up to exposures 4.0-times the MRHD. The incidences of malformations and pregnancy loss in human pregnancies have not been established for OTEZLA. However, all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. OTEZLA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations Labor or delivery The effects of OTEZLA on labor and delivery in pregnant women are unknown. In mice, dystocia was noted at doses corresponding to ≥4.0-times the MRHD (on an AUC basis at doses ≥80 mg/kg/day) of apremilast. Animal Data Monkey embryo-fetal development: In an embryo-fetal developmental study, cynomolgus monkeys were administered apremilast at doses of 20, 50, 200, or 1000 mg/kg/day during the period of organogenesis (gestation Days 20 through 50). There was a dose-related increase in spontaneous abortions, with most abortions occurring during weeks 3 to 4 of dosing in the first trimester, at doses approximately 2.1-times the MRHD and greater (on an AUC basis at doses ≥50 mg/kg/day). No abortifacient effects were observed at a dose approximately 1.4-times the MRHD (on an AUC basis at a dose of 20 mg/kg/day). Although, there was no evidence for a teratogenic effect at doses of 20 mg/kg/day and greater when examined at day 100, aborted fetuses were not examined. Mouse embryo-fetal development: In an embryo-fetal development study, apremilast was administered at doses of 250, 500, or 750 mg/kg/day to dams during organogenesis (gestation Day 6 through 15). In a combined fertility and embryo-fetal development study, apremilast was administered at doses of 10, 20, 40 or 80 mg/kg/day starting 15 days before cohabitation and continuing through gestation Day 15. No teratogenic findings attributed to apremilast were observed in either study; however, there was an increase in postimplantation loss at doses corresponding to a systemic exposure of 2.3-times the MRHD and greater (≥20 mg/kg/day). At doses of ≥20 mg/kg/day skeletal variations included incomplete ossification sites of tarsals, skull, sternebra, and vertebrae. No effects were observed at a dose approximately 1.3-times the MRHD (10 mg/kg/day). Mouse pre- and postnatal development: In a pre- and postnatal study in mice, apremilast was administered to pregnant female mice at doses of 10, 80, or 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation, with weaning on day 21. Dystocia, reduced viability, and reduced birth weights occurred at doses corresponding to ≥4.0-times the MRHD (on an AUC basis at doses ≥80 mg/kg/day). No adverse effects occurred at a dose 1.3-times the MRHD (10 mg/kg/day). There was no evidence for functional impairment of physical development, behavior, learning ability, immune competence, or fertility in the offspring at doses up to 7.5-times the MRHD (on an AUC basis at a dose of 300 mg/kg/day). 8.3 Nursing Mothers It is not known whether OTEZLA or its metabolites are present in human milk; however apremilast was detected in milk of lactating mice. Because many drugs are present in human milk, caution should be exercised when OTEZLA is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of OTEZLA in pediatric patients less than 18 years of age have not been established. 8.5 Geriatric Use Of the 1493 subjects who enrolled in Studies PsA-1, PsA-2, and PsA-3 a total of 146 psoriatic arthritis subjects were 65 years of age and older, including 19 subjects 75 years and older. No overall differences were observed in the safety profile of elderly subjects ≥65 years of age and younger adult subjects <65 years of age in the clinical studies. Of the 1257 subjects who enrolled in two placebo-controlled psoriasis trials (PSOR 1 and PSOR 2), a total of 108 psoriasis subjects were 65 years of age and older, including 9 subjects who were 75 years of age and older. No overall differences were observed in the efficacy and safety in elderly subjects ≥65 years of age and younger adult subjects <65 years of age in the clinical trials. 8.6 Renal Impairment Apremilast pharmacokinetics were characterized in subjects with mild, moderate, and severe renal impairment as defined by a creatinine clearance of 60-89, 30-59, and less than 30 mL per minute, respectively, by the Cockcroft–Gault equation. While no dose adjustment is needed in patients with mild or moderate renal impairment, the dose of OTEZLA should be reduced to 30 mg once daily in patients with severe renal impairment [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment Apremilast pharmacokinetics were characterized in subjects with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment. No dose adjustment is necessary in these patients. 10 OVERDOSAGE In case of overdose, patients should seek immediate medical help. Patients should be managed by symptomatic and supportive care should there be an overdose. 11 DESCRIPTION The active ingredient in OTEZLA tablets is apremilast. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C22H24N2O7S and the molecular weight is 460.5. The chemical structure is:
b Statistically significantly different from placebo (p<0.05). OTEZLA 30 mg twice daily resulted in improvement for each ACR component, compared to placebo at Week 16 in Study PsA-1 (Table 5). Consistent results were observed in Studies PsA-2 and PsA-3. Table 5: ACR Components Mean Change from Baseline at Week 16 in Study PsA- 1
a Scale 0-78. b Scale 0-76. c VAS=Visual Analog Scale; 0=best, 100=worst. d HAQ-DI = Health Assessment Questionnaire-Disability Index; 0=best, 3=worst; measures the subject’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity. e CRP = C-reactive protein; Reference range 0-0.5 mg/dL N reflects randomized patients; actual number of patients evaluable for each endpoint may vary by timepoint. Treatment with OTEZLA resulted in improvement in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis. Physical Function Response OTEZLA 30 mg twice daily demonstrated a greater improvement compared to placebo in mean change from baseline for the Health Assessment Questionnaire Disability Index (HAQ-DI) score at Week 16 [-0.244 vs. -0.086, respectively; 95% CI for the difference was (-0.26, -0.06)] in Study PsA-1. The proportions of HAQ-DI responders (≥0.3 improvement from baseline) at Week 16 for the OTEZLA 30 mg twice daily group were 38%, compared to 27%, for the placebo group in Study PsA-1. Consistent results were observed in Studies PsA-2 and PsA-3. 14.2 Psoriasis Two multicenter, randomized, double-blind, placebo-controlled trials (Studies PSOR-1 and PSOR-2) enrolled a total of 1257 subjects 18 years of age and older with moderate to severe plaque psoriasis [body surface area (BSA) involvement of ≥10%, static Physician Global Assessment (sPGA) of ≥3 (moderate or severe disease), Psoriasis Area and Severity Index (PASI) score ≥12, candidates for phototherapy or systemic therapy]. Subjects were allowed to use low-potency topical corticosteroids on the face, axilla and groin. Subjects with scalp psoriasis were allowed to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. Study PSOR-1 enrolled 844 subjects and Study PSOR-2 enrolled 413 subjects. In both studies, subjects were randomized 2:1 to OTEZLA 30 mg BID or placebo for 16 weeks. Both studies assessed the proportion of subjects who achieved PASI-75 at Week 16 and the proportion of subjects who achieved a sPGA score of clear (0) or almost clear (1) at Week 16. Across both studies, subjects ranged in age from 18 to 83 years, with an overall median age of 46 years. The mean baseline BSA involvement was 25.19% (median 21.0%), the mean baseline PASI score was 19.07 (median 16.80), and the proportion of subjects with sPGA score of 3 (moderate) and 4 (severe) at baseline were 70.0% and 29.8%, respectively. Approximately 30% of all subjects had received prior phototherapy and 54% had received prior conventional systemic and/or biologic therapy for the treatment of psoriasis with 37% receiving prior conventional systemic therapy and 30% receiving prior biologic therapy. Approximately one-third of subjects had not received prior phototherapy, conventional systemic nor biologic therapy. A total of 18% of subjects had a history of psoriatic arthritis. Clinical Response in Subjects with Plaque Psoriasis The proportion of subjects who achieved PASI -75 responses, and sPGA score of clear (0) or almost clear (1), are presented in Table 6. Table 6: Clinical Response at Week 16 in Studies PSOR-1 and PSOR-2
b PASI=Psoriasis Area and Severity Index. c sPGA=Static Physician Global Assessment The median time to loss of PASI-75 response among the subjects re-randomized to placebo at Week 32 during the Randomized Treatment Withdrawal Phase was 5.1 weeks. 16 HOW SUPPLIED/STORAGE AND HANDLING OTEZLA is available as diamond-shaped, film-coated tablets in the following dosage strengths: 10-mg pink tablet engraved with “APR” on one side and “10” on the other side; 20-mg brown tablet engraved with “APR” on one side and “20” on the other side; 30-mg beige tablet engraved with “APR” on one side and “30” on the other side. Tablets are supplied in the following strengths and package configurations:
Store tablets below 30°C (86°F). 17 PATIENT COUNSELING INFORMATION Depression Before using OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with OTEZLA in such patients. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with OTEZLA if such events occur. [See Warnings and Precautions (5.1)]. Weight Decrease Patients treated with OTEZLA should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of OTEZLA should be considered [see Warnings and Precautions (5.2)]. Drug Interactions The use of strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA is not recommended [see Warnings and Precautions (5.3), Drug Interactions (7.1), and Clinical Pharmacology (12.3)]. Instruct patients to take OTEZLA only as prescribed. Advise patients OTEZLA can be taken with or without food. Advise patients that the tablets should not be crushed, split, or chewed. Advise patients about the side effects associated https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3acf6751-827d-11e2-9e96-0800200c9a66 美国食品药品管理局核准OralOTEZLA(apremilast)用于治疗中重度斑块状银屑病患者 • III期研究显示，OTEZLA可使斑块状银屑病出现显著的、有临床意义的改善 • 各项临床试验均显示，OTEZLA具有一致的安全性和耐受性 新泽西州萨米特 -- (美国商业资讯) -- Celgene Corporation (NASDAQ: CELG)今天宣布，美国食品药品管理局(FDA)已核准该公司的磷酸二酯酶4 (PDE4) 选择性抑制剂口服制剂OTEZLA® (apremilast)用于治疗适用于光疗或全身疗法的中重度斑块状银屑病患者。OTEZLA是首个也是唯一获准用于治疗斑块状银屑病的PDE4抑制剂。银屑病是免疫反应失控所致的皮肤慢性炎性疾病，全球患病人数超过1.25亿。 Dartmouth-Hitchcock医疗中心皮肤科主任M. Shane Chapman博士说：“OTEZLA为现有治疗无法充分改善症状的患者提供了重要的新治疗选择。临床试验显示，OTEZLA可减少中重度斑块状银屑病患者的红斑、增厚和脱屑。由于该产品说明书没有要求进行实验室常规监测，口服OTEZLA可能是那些正在寻求不同治疗体验的患者和医生欢迎的新选择。” OTEZLA获批主要基于2项多中心、安慰剂对照、随机双盲研究的安全性和有效性结果—— ESTEEM 1和ESTEEM 2——受试者为 中重度斑块状银屑病成人患者：体表面积(BSA)受累≥10%、医师静态总评(sPGA) of ≥3（中重度疾病）、银屑病面积和严重程度指数 (PASI)评分≥12以及适用于光疗或全身疗法。 Celgene Corporation炎症和免疫部总裁Scott Smith说：“OTEZLA为广大斑块状银屑病患者提供了有价值的治疗选择，包括初治患者和经治患者，以及既往用过生物制剂或传统全身药物的患者。FDA核准OTEZLA用于斑块状银屑病，加上既往核准用于银屑病关节炎，体现了Celgene拓展科研疆域、从而改善全球慢性炎性疾病患者生活的承诺。” ESTEEM研究显示，OTEZLA治疗16周后，按PASI评分衡量，斑块状银屑病的改善有统计学意义和临床意义。按sPGA评分衡量，2项研究均显示有临床改善（消失至几乎消失）。 3项临床试验的1,426例患者中评估了OTEZLA的安全性。OTEZLA的副作用有腹泻、恶心、上呼吸道感染、紧张性头痛和头痛。患者若在启用OTEZLA之前有抑郁症或自杀行为的病史，或在服用OTEZLA期间有上述病况或其他心境变化之发生或加重，均须告知医生。患者服用OTEZLA期间须定期测量体重。 国立银屑病基金会总裁兼首席执行官Randy Beranek说：“银屑病是严重的自身免疫障碍，常有合并症。有效治疗银屑病是掌控患者整体健康的重要组成部分。类似OTEZLA这样的新治疗至关重要，患者因此有了更多的选择，能够与他们的提供者密切合作适合自身的最佳治疗。” OTEZLA®在美国通过一个专科药店组成的完整网络进行发售和配方。有关OTEZLA分销和排他性治疗支持服务（包括理赔协助和24/7护士支持）的进一步信息，医师和患者请联系Otezla SupportPlus™ ， 2014年3月21日，美国食品药品管理局(FDA)核准OTEZLA用于活动性银屑病关节炎成人患者的治疗。 用于银屑病关节炎的新药申报(NDS)在2013年第二季度递交给加拿大卫生部门。加拿大的银屑病NDS、欧洲的银屑病关节炎/银屑病联合上市授权申请(MAA)均在2013年第四季度递交给卫生部门。 关于 ESTEEM ESTEEM 1和2是两项大样本、枢纽性、安慰剂对照随机III期研究，评估OTEZLA用于中重度斑块状银屑病患者，患者在筛选之前已获诊至少12个月，且为光疗和/或全身疗法的候选者。约1,250例患者先经过5天剂量递增阶段，然后按2:1比例随机接受OTEZLA 30毫克每天2次或安慰剂，治疗16周，然后是维持期，从第16周持续至第32周，期间安慰剂组患者换用OTEZLA 30毫克每天2次直至第32周，第32～52周是应答者的随机撤药期， 根据他们的最初OTEZLA随机分配和PASI-75应答。 关于OTEZLA OTEZLA是磷酸二酯酶4 (PDE4)的小分子抑制剂口服制剂，特定作用于单磷酸环腺苷酸(cAMP)。PDE4抑制可导致细胞内cAMP水平升高，后者据信可间接调控炎症介质的生成。OTEZLA对银屑病或银屑病关节炎患者发挥治疗作用的特定机制并未明确。 适应证 OTEZLA® (apremilast) 适用于治疗中重度斑块状银屑病患者，这些患者也是光疗或全身疗法的候选者。 OTEZLA也适用于治疗活动性银屑病关节炎成人患者。 其他重要安全性信息 已知对apremilast或OTEZLA的任何成份有变态反应的患者不得服用OTEZLA。服用OTEZLA期间，不得服用某些药物，因为它们可能降低OTEZLA的疗效。患者须将自己服用的所有药物告知医生，包括处方药和非处方药。女性须将自己是否妊娠、或是否打算哺乳告知医生。OTEZLA尚未在妊娠女性或哺乳女性中进行过研究。这些并非OTEZLA的全部可能的副作用。患者须向医生询问有关其他潜在的副作用，并将困扰自己或无法消除的任何副作用告知医生。 建议患者向FDA上报处方药的不良副作用。请访问www.fda.gov/medwatch或拨打1-800-332-1088。 关于银屑病 银屑病是免疫介导的非传染性慢性炎性皮肤病，病因不明。该病为慢性复发性疾病，严重程度不一，轻者为局限性斑块，重者殃及全身。斑块状银屑病是银屑病最常见类型。约80%的银屑病患者为斑块状银屑病，外观为突起的、红色的皮肤斑块，被银白色鳞片覆盖。斑块常形成于肘部、膝部、下背部和头皮。银屑病的男女患病率接近。全球银屑病患者估计有1.25亿。 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
