Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France

Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®

时间窗: Up to 12 months

Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

Indications for Which Arcoxia® and Celebrex® Were Prescribed

时间窗: At study entry

The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.

Reasons for Misuse of Arcoxia® and Celebrex®

时间窗: Up to 12 months

Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

Type of Arcoxia® and Celebrex® Use

时间窗: Up to 12 months

The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption \>7 days) or intermittent (with interruption \>7 days) by the Investigating Physician at time of treatment discontinuation.

Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®

时间窗: Up to 12 months

Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.

Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®

时间窗: Up to 12 months

Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.

Dosage of Arcoxia® and Celebrex® at Initiation

时间窗: At study entry

Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.

Mean Dosage of Arcoxia® and Celebrex® During Treatment

时间窗: Up to 12 months

The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.

Duration of Prescription for Arcoxia® and Celebrex® at Enrollment

时间窗: Up to 3 months prior to study entry

The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.

Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®

时间窗: Up to 12 months

The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.

Total Duration of Treatment With Arcoxia® and Celebrex®

时间窗: Up to 12 months

The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.

Type of Arcoxia® and Celebrex® Use According to Duration of Treatment

时间窗: Up to 12 months

Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption \>7 days) or intermittent (with interruption \>7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.