{
 "query": "guselkumab",
 "ingredient": "guselkumab",
 "slug": "guselkumab",
 "rxcui": "1928588",
 "brands": [
  "Tremfya"
 ],
 "names": [
  "guselkumab"
 ],
 "classes": [
  {
   "id": "L04AC",
   "name": "Interleukin inhibitors"
  }
 ],
 "alternatives": [
  "anakinra",
  "basiliximab",
  "bimekizumab",
  "brodalumab",
  "canakinumab",
  "daclizumab",
  "ixekizumab",
  "mirikizumab",
  "rilonacept",
  "risankizumab",
  "sarilumab",
  "satralizumab",
  "secukinumab",
  "siltuximab",
  "spesolimab",
  "tildrakizumab",
  "tocilizumab",
  "ustekinumab"
 ],
 "label": {},
 "faers": {
  "total": 35562,
  "serious": 9043,
  "death": 458,
  "hospitalization": 2670,
  "primary_suspect": 35552,
  "top_reactions": [
   [
    "Product Dose Omission Issue",
    11426
   ],
   [
    "Accidental Exposure To Product",
    3518
   ],
   [
    "Drug Ineffective",
    2459
   ],
   [
    "Needle Issue",
    2305
   ],
   [
    "Psoriasis",
    2240
   ],
   [
    "Device Issue",
    1980
   ],
   [
    "Device Malfunction",
    1655
   ],
   [
    "Off Label Use",
    1537
   ],
   [
    "Device Deployment Issue",
    1495
   ],
   [
    "Product Storage Error",
    1212
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    1028
   ],
   [
    "Device Defective",
    997
   ],
   [
    "Arthralgia",
    958
   ],
   [
    "Device Leakage",
    921
   ],
   [
    "Product Leakage",
    875
   ]
  ],
  "by_year": {
   "2019": 2089,
   "2020": 2195,
   "2021": 3115,
   "2022": 5057,
   "2023": 5776,
   "2024": 5014,
   "2025": 6819,
   "2026": 4211
  },
  "by_year_primary": {
   "2019": 2089,
   "2020": 2195,
   "2021": 3113,
   "2022": 5051,
   "2023": 5774,
   "2024": 5014,
   "2025": 6819,
   "2026": 4211
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20170713",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "JANSSEN BIOTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/13/2017"
 },
 "trials": {
  "total": 142,
  "completed": 52,
  "terminated": 11,
  "with_results": 38,
  "industry": 110,
  "phase3": 38,
  "results_share": 0.7307692307692307,
  "terminated_share": 0.07746478873239436
 },
 "pubmed": {
  "rct": 107,
  "meta": 11,
  "recent_rct": 71,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 20198987.19,
  "records": 190389,
  "by_name": [
   [
    "Tremfya",
    20198987.19
   ]
  ],
  "names_checked": [
   "guselkumab",
   "Tremfya"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 46093,
  "beneficiaries": 10860,
  "spend": 619021085.8,
  "by_brand": [
   {
    "brand": "Tremfya",
    "claims": 46079,
    "per_claim": 13428.775433,
    "is_generic": false
   },
   {
    "brand": "Tremfya Pen",
    "claims": 14,
    "per_claim": 16895.902143,
    "is_generic": false
   }
  ],
  "per_claim": 13429.828516260603
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 57,
   "letter": "D",
   "why": [
    "107 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $20,198,987 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are product dose omission issue, accidental exposure to product, needle issue. How would we recognize and handle those?",
  "Why this one over anakinra, basiliximab, bimekizumab? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}